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open access protocol effects of diet on obesity related bmj open first published as 10 1136 bmjopen 2021 050579 on 13 january 2022 downloaded from anthropometric characteristics in adults a ...

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                Open access                                                                                                                                                      Protocol
                                                    Effects of diet on obesity- related                                                                                                                   BMJ Open: first published as 10.1136/bmjopen-2021-050579 on 13 January 2022. Downloaded from 
                                                    anthropometric characteristics in adults: 
                                                    a protocol for an umbrella review of 
                                                    meta- analyses of randomised 
                                                    controlled trials
                                                                               1                          1                     1                1                 2
                                                    Shunlian Fu     ,  Qian Zhou      ,  Lijun Yuan,  Zinan Li,  Qiu Chen
               To cite: Fu S, Zhou Q, Yuan L,       ABSTRACT                                                                   Strengths and limitations of this study
               et al.  Effects of diet on           Introduction  There have been many meta- analyses of 
               obesity- related  anthropometric     randomised controlled trials on the influence of different 
               characteristics in adults: a         diets on obesity- related anthropometric characteristics in                ► The included outcomes contain as comprehensive a 
               protocol for an umbrella review      adults. However, whether diet interventions can effectively                    range of obesity-rela    ted anthropometric character-
               of meta- analyses of randomised      decrease obesity- related anthropometric characteristics                       istics as possible.
               controlled trials. BMJ Open          remains unclear. The objective of this study is to                         ► A substantial number of original research papers 
               2022;12:e050579. doi:10.1136/                                                                                       and participants are included.
               bmjopen-2021-050579                  summarise and synthesise the evidence on the effects                       ► This paper covers types of food as comprehensively 
               ► Prepublication history and         of diet on obesity- related anthropometric characteristics                     as possible.
               additional supplemental material     in adults by an umbrella review of meta- analyses of                       ► We will try to address the heterogeneity of included 
               for this paper are available         randomised controlled trials.                                                  systematic reviews.
               online. To view these files,         Methods and analysis  We will first retrieve English                       ► This umbrella review will be limited by including only 
               please visit the journal online      articles only published before 15 December 2021 by                             full texts in English language.
               (http://dx.doi.org/10.1136/          searching PubMed, Embase and Web of Science. Only 
               bmjopen-2021-050579).                articles that are meta- analyses of randomised controlled 
                                                    trials will be included. Three researchers will independently 
               Received 24 February 2021            screen the titles and abstracts of retrieved articles and                                 1–5
               Accepted 21 December 2021                                                                                     economics.            What is more concerning is 
                                                    check the data extracted from each eligible meta-analysis.          
                                                    In each meta-analysis,     we will consider calculating the              that the number of individuals with obesity                                  http://bmjopen.bmj.com/
                                                                                                                             and overweight continues to rise.2–7 Many 
                                                    effect size of the mean difference of the effect of each                 studies have documented an association 
                                                    diet on obesity- related anthropometric characteristics                  between obesity and various chronic diseases 
                                                    in adults using a random- effect model or a fixed- effect 
                                                    model according to heterogeneity. Study heterogeneity                    such as cancer, type 2 diabetes, cardiovas-
                                                                          2 statistics) and small- study effects             cular disease, hypertension, stroke, dyslip-
                                                    (Cochrane’s Q and I
                                                                                                                                                                                       2–6 8–10
                                                    (Egger’s test or Begg’s test) will be considered. Evidence of            idaemia and reproductive disorder.                                    
                                                    each effect size will be graded according to the NutriGrade              People usually use a multifactorial stepwise 
                                                    scoring system. We will use AMSTAR- 2 (A Measurement                     approach consisting of behavioural therapy,                                   on January 4, 2023 by guest. Protected by copyright.
                                                    Tool to Assess Systematic Reviews V.2) to assess the                     lifestyle and dietary interventions, and 
                                                    methodological quality of each meta- analysis.                           medical pharmacotherapy to manage obesity. 
               © Author(s) (or their                Ethics and dissemination  This umbrella review will                      However, interventions that are mostly based 
               employer(s)) 2022. Re- use           provide information on the effects of different diets on                 on educational, behavioural or pharmaco-
               permitted under CC BY- NC. No        obesity- related anthropometric characteristics in adults. 
               commercial re- use. See rights       Ethical approval is not necessary for this study. We will                logical measures are not very effective in 
                                                                                                                                                                                 11 12
               and permissions. Published by        publish the completed umbrella review and related data                   preventing and treating obesity.                           Over-
               BMJ.                                 online.                                                                  weight/obesity is often caused by a long- term 
               1Hospital of Chengdu University      PROSPERO registration number  CRD42021232826.                            energy imbalance between intake and expen-
               of Traditional Chinese Medicine,                                                                                                                             13
               Chengdu, Sichuan, China                                                                                       diture, leading to weight gain.  Diet charac-
               2Department of Endocrinology,                                                                                 terised by a low intake of high- energy- dense 
               Hospital of Chengdu University       INTRODUCTION                                                             foods and a high intake of low- energy- dense 
                                                                                                                                                                                               13
               of Traditional Chinese Medicine,     The problem of obesity and overweight has                                foods can counteract such an imbalance.  
               Chengdu, Sichuan, China              become extremely serious either in adults  Diet is a major modifiable determinant of 
               Correspondence to                    or in children, and in 2016 more than half                               obesity, and diet quality has been defined as 
               Dr Qiu Chen;                         of adults in the world were overweight or                                the degree to which a diet reduces the risk of 
                chenqiu1005@ cdutcm. edu. cn        obese, putting a huge burden on global  non- communicable  diseases.14 15 Therefore, 
                                                                Fu S, et al. BMJ Open 2022;12:e050579. doi:10.1136/bmjopen-2021-050579                                                          1
                      Open access 
                    dietary intervention is the cornerstone of addressing the                                                                         inclusion criteria and exclusion criteria. A detailed flow                                                                         BMJ Open: first published as 10.1136/bmjopen-2021-050579 on 13 January 2022. Downloaded from 
                    obesity epidemic.                                                                                                                 chart of article selection is shown in online supplemental 
                         Diet can produce changes in anthropometric param-                                                                            figure 1. The second step is to make a forest plot showing 
                    eters and body composition of overweight and obese                                                                                the effect of different diets on different parameters. We 
                                      16                                                                                                              will score the included literature. If there are several 
                    patients.  Some studies found that whole grains, fruits, 
                    nuts, beans and fish are associated with a reduced risk of                                                                        included articles describing the effects of the same food 
                    obesity, while refined grains, red meat and sugary bever-                                                                         on the same obesity-related parameters, we will select the  
                                                                                                                  13 17 18                            one with the highest score and present them in a forest 
                    ages are associated with an increased risk.                                                                  After 
                    extensive research, intervention studies have shown short-                                                                        plot.
                    term effects between optimal intake of food and treat-                                                                            Eligibility criteria
                    ment of obesity. However, there is little information on 
                    the role of specific food groups and their optimal intake                                                                         Types of participants
                    in preventing obesity. Also, there has been no study that                                                                         The general human population will be considered, 
                    focused on any existing evidence on the effect of dietary                                                                         regardless of sex, race and region.
                    factors (single food and beverages, alcohol, macronutri-                                                                          Types of exposure (intervention)
                    ents and micronutrients) on obesity-related anthropo                                                                   -          The intervention is the different types of diet. Based on 
                    metric characteristics, including body mass index (BMI),                                                                                                                                            13 23 24
                    waist circumference (WC), body fat, hip circumference                                                                             previously published literature,                                               we will divide diets 
                    (HC) and waist to hip ratio (WHR). Thus, it is critical                                                                           into the following: dietary patterns, including ketogenic 
                    to develop and evaluate the validity of dietary differences                                                                       diet, Mediterranean diet, etc; food groups, foods and 
                    and assess diet quality in a population, as well as test their                                                                    beverages, including whole grain, fruit, nut, legume, dairy 
                    ability to predict weight and adiposity. A clear public                                                                           products, eggs, meat, fish, fats (eg, butter), oil, tea, garlic, 
                    health plan that assesses the strength, precision and influ-                                                                      gum, refined grains, sugar-sweetened beverages, etc; and  
                                                                                                                     19–21                            macronutrients, micronutrients (vitamins, minerals) and 
                    ence of potential bias needs to be established.                                                                                   fibre.
                         Therefore, we plan to establish a clear public health plan 
                    that provides potential new insights that can be used in                                                                          Types of comparator
                    future research on developing preventive nutrition strat-                                                                         Foods that were different from the intervention group 
                    egies and a convenient tool to screen for those at risk of                                                                        will be considered as the control group.
                    undernutrition or overnutrition. In this umbrella review 
                    of meta- analyses, we aimed to conduct an umbrella review                                                                         Types of outcome
                    of meta-analyses                   of randomised controlled trials (RCT) to                                                       The main outcome is the pooled mean difference in WC 
                    comprehensively summarise and synthesise the evidence                                                                             (in centimetres), pooled mean difference in BMI (in 
                    on the effects of diet on obesity-related anthropometric                                                                          kilograms per square metre), pooled mean difference in 
                    characteristics in adults. Furthermore, we aimed to assess                                                                        fat mass (body fat; in kilograms) or pooled mean differ-                                                                           http://bmjopen.bmj.com/
                    methodological quality using validated tools to identify                                                                          ence in HC (in centimetres). The secondary outcome is 
                    the optimal intake of these food groups to reduce the risk                                                                        pooled mean difference in weight change (in kilograms), 
                    of each outcome separately.                                                                                                       pooled mean difference in lean mass (in kilograms), 
                                                                                                                                                      pooled mean difference in free fat mass (in kilograms) or 
                    METHODS AND ANALYSIS                                                                                                              pooled mean difference in WHR.
                    Protocol registration and reporting of findings
                    We have registered the article with the International                                                                             Inclusion criteria
                    Prospective Register of Systematic Reviews (https://                                                                              We considered including meta-analyses of RCT because                                                                                on January 4, 2023 by guest. Protected by copyright.
                    www.crd.york.ac.uk/prospero/) on 23 January 2021. We                                                                              the results of RCT are more convincing than the results of 
                                                                                                                                                                                                    25
                    referred to the Preferred Reporting Items for Systematic                                                                          other types of studies.  We aimed to study the influence 
                                                                                                                               22                     of diet on obesity-related parameters                                            in adults. Because 
                                                          Analysis Protocols                     2015 checklist  (see 
                    Review and Meta-
                    online supplemental table 1). We will provide any amend-                                                                          body weight, WC and other anthropometric parameters 
                    ments to the protocol as supplementary materials in the                                                                           in adults are not as susceptible to growth and develop-
                    publication of the final results.                                                                                                 ment, the results on the influence of diet on these anthro-
                    Patient and public involvement                                                                                                    pometric parameters could be more reliable. To better 
                    The study is an umbrella review focusing on the effects                                                                           and more accurately evaluate the impact of these foods 
                    of diet on obesity-related anthropometric characteris                                                                  -          on obesity-related                        parameters, we will only consider 
                    tics. We did not set any restrictions to region or sex of                                                                         including articles where the outcomes contain at least 
                    the included population. There is no patient or public                                                                            two of the following items: WC, BMI, fat mass (body fat) 
                    involvement in this study.                                                                                                        and HC. Meanwhile, to better compare the influence 
                                                                                                                                                      of different foods on obesity-related parameters,                                                         we will 
                    Study design                                                                                                                      unify the units of these weight parameters as follows: WC 
                    We divide the process into two steps. The first step is                                                                           in centimetres, BMI in kilograms per square metre, fat 
                    to screen out the included literature according to the                                                                            mass in kilograms and HC in centimetres. At the same 
                    2                                                                                                                                         Fu S, et al. BMJ Open 2022;12:e050579. doi:10.1136/bmjopen-2021-050579
                                                                                                                             Open access
           time, to quantitatively study the effects of these foods on         number of included studies, intervention diet, control                BMJ Open: first published as 10.1136/bmjopen-2021-050579 on 13 January 2022. Downloaded from 
           obesity- related parameters, we will consider including             diet, number of included studies, number of subjects 
           articles that reported pooled mean difference in obesity-           included in the intervention group, number of subjects 
           related parameters between the intervention and the                 included in the control group, duration of interven-
           control group.                                                      tion, study population, outcomes of interest, baseline of 
                                                                               outcomes of interest and the final results after the inter-
           Exclusion criteria                                                  vention. All data will be recorded in Excel according to 
           We will not include articles on the effects of diet on obesity-     previously designed content.
           related parameters among pregnant and lactating women 
           given that pregnant and lactating women are highly                  Assessment of methodological quality and of certainty in the 
           influenced by other factors. We will not include confer-            findings
           ences, abstracts, correspondence, etc. If an article has            We will assess the quality of included systematic reviews 
           incomplete data, we will exclude the article if complete            using AMSTAR- 2 (A Measurement Tool to Assess System-
                                                                                                    27
           data cannot be obtained after contacting the author. We             atic Reviews V.2),  which includes 16 items (7 critical 
           will not include articles that examine the effects of diet          domains and 9 non- critical domains). According to the 
           on obesity- related parameters among people with infec-             tool, two reviewers will classify the results of the included 
           tious diseases, severe acute and chronic diseases, etc. We          systematic reviews as high, moderate, low and critically 
           will also exclude articles where we could not identify the          low. If the study has no or one non- critical weakness, we 
           effect of the intervention food on obesity-related parame      -    will appraise it as high; if more than one non-critical weak    -
           ters. To quantitatively study the effects of diet on obesity-       ness, we will appraise it as moderate; if one critical flaw 
           related parameters, we will not include systematic reviews          with or without non-critical weakness, we will appraise it  
           without  meta- analysis.                                            as low; and if more than one critical flaw with or without 
                                                                               non- critical weakness, we will appraise it as critically low.
           Information source and search strategy                                                                                  28
                                                                                  In addition, we will carry out NutriGrade  grading 
           We will only retrieve English articles published before 15          for obesity- related parameters for each diet to assess 
           December 2021 by searching PubMed and Embase. We                                                                  28
                                                                               certainty in the findings. The NutriGrade  scoring system 
           did not set any restrictions when searching. We will only           comprises seven items with a total score of 10 for system-
           include articles that are meta- analyses of RCT. There have         atic reviews and meta- analyses of RCT. The following are 
           been several umbrella reviews that summarised the role              the seven items: (1) risk of bias, study quality and study 
                                                    23 24 26
           of diet in type 2 diabetes incidence,            and by refer-      limitations (3 points); (2) precision (1 point); (3) hetero-
           ring to their search terms we determined the following              geneity (1 point); (4) directness of evidence (1 point); 
           keywords: diet or beverages or soy or sugar or egg or               (5) publication bias (1 point); (6) funding bias (1 point); 
           macronutrient or micronutrient. More details are shown              and (7) study design (2 points). Studies with a total score 
           in online supplemental tables 2 and 3. We will import the           of  ≥8, 6–7.99, 4–5.99 and 0–3.99 points are graded as                http://bmjopen.bmj.com/
           search results into the EndNote V.X9 software and use               having high, moderate, low and very low confidence in 
           it to remove duplicate articles. We will also include grey          the effect estimate, respectively.
           literature. If necessary, we will contact the corresponding 
           authors of the included systematic reviews to collect               Data analysis
           missing data on the main endpoints or to ask regarding              First, we will recalculate the summary effect and 95% CI 
           unclear information.                                                using a random- effect model by DerSimonian and Laird 
                                                                               after adjusting for most confounders in the published 
           Data extraction                                                     meta- analyses. If the same outcome is presented by                    on January 4, 2023 by guest. Protected by copyright.
           Two researchers will separately check the data extracted            sex or race in the published meta-analysis, we will first  
           from each eligible meta-analysis. If there is a disagree       -    combine the effect size using fixed-effect methods before  
           ment, a third researcher will join the analysis. We will            conducting the overall meta-analysis. Second, we will use  
           extract the following data from the included meta-                   2
                                                                               I  statistics or Cochran’s Q test to determine the magni-
           analyses: first author and year of publication, number of                                     29
                                                                               tude of heterogeneity.  For Cochrane’s Q test, we will 
           included studies, intervention diet, control diet, number           consider the result as significant heterogeneity when 
           of included studies, number of subjects included in the                          2
                                                                               p<0.1; for I  statistics, we will classify the result as signif-
           intervention group, number of subjects included in the                                                 2
                                                                               icant heterogeneity when the I  value is ≤50%. Third, we 
           control group, duration of intervention, study popula-              will estimate publication bias and small- study effect by 
           tion, outcomes of interest and pooled effect size of the            Egger’s test (as confirmed by a p value of <0.1) or Begg’s 
           mean difference of outcomes of interest, along with 95%                                                         30
                                                                               test (as confirmed by a p value of <0.1).  If the published 
           CI, p values, heterogeneity (I index), publication bias             meta- analysis has missing information, we will not recal-
           (Egger’s test and Begg’s test values) and the quality of            culate the meta- analysis and will only extract the effect 
           the studies included in each meta-analysis. For primar         y    size. In addition, a series of subgroup analyses, such as 
           studies included in the meta-analyses,        we will extract       classification by disease, sex and race, will be performed. 
           the following data: first author and year of publication,           We will also show our results according to food groups, 
           Fu S, et al. BMJ Open 2022;12:e050579. doi:10.1136/bmjopen-2021-050579                                                             3
                   Open access 
                 such as whole grains, refined grains, fruit, nut, legume,                                                    ETHICS AND DISSEMINATION                                                                                       BMJ Open: first published as 10.1136/bmjopen-2021-050579 on 13 January 2022. Downloaded from 
                 dairy products, eggs, meat, fish, fats, oil, tea, garlic,                                                    This is an umbrella review. We will not conduct any exper-
                 gum and sugar- sweetened beverages. Finally, we will use                                                     iments on humans or animals so we will not consider an 
                 AMSTAR- 2 to assess the methodological quality in tabular                                                    ethical review. We will publish the results of this umbrella 
                 form for each review. NutriGrade will be used to evaluate                                                    review in a peer- reviewed journal.
                 the quality of evidence, which will be presented in tabular 
                 form. All statistical analyses will be conducted using                                                       Contributors  All authors contributed to the design of this protocol. SF, QZ, LY, 
                 Review Manager (RevMan, V.5.3 for Macintosh; The                                                             ZL and QC initiated the project. The protocol was drafted by SF and was refined 
                 Cochrane Collaboration) and the PASW V.20.0 statistical                                                      by QZ. Statistical advice was provided by QC. SF was responsible for drafting the 
                                                                                                                              manuscript. All authors contributed to the manuscript and read and approved the 
                 package for Macintosh (SPSS).                                                                                final manuscript.
                                                                                                                              Funding  The article is funded by the ‘Pilot project of collaboration between 
                                                                                                                              traditional Chinese medicine and western medicine for major and difficult diseases’ 
                                                                                                                              (CYW2019079) and the funder was not involved in the writing.
                 DISCUSSION                                                                                                   Competing interests  None declared.
                 By an umbrella review of meta-analyses of RCT                                         , Dinu et              Patient consent for publication  Not required.
                    31
                 al  published an article on the effects of popular diets                                                     Provenance and peer review  Not commissioned; externally peer reviewed.
                 on anthropometric and cardiometabolic parameters.                                                            Supplemental material  This content has been supplied by the author(s). It has 
                 However, they only sorted out the effects of dietary                                                         not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been 
                 patterns on BMI and weight, as well as other cardiometa-                                                     peer- reviewed. Any opinions or recommendations discussed are solely those 
                                                                                             32                               of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and 
                 bolic parameters. Akhlaghi and colleagues  thought soy 
                 showed no overall statistically significant effect on weight,                                                responsibility arising from any reliance placed on the content. Where the content 
                                                                                                  33                          includes any translated material, BMJ does not warrant the accuracy and reliability 
                 WC or fat mass. However, Mu and colleagues  held that                                                        of the translations (including but not limited to local regulations, clinical guidelines, 
                 soy products significantly reduced body weight, BMI,                                                         terminology, drug names and drug dosages), and is not responsible for any error 
                 body fat per cent and WC in overweight or obese Asian                                                        and/or omissions arising from translation and adaptation or otherwise.
                 populations, and more significant effects were observed                                                      Open access  This is an open access article distributed in accordance with the 
                                                                                                                   34         Creative Commons Attribution Non Commercial (CC BY- NC 4.0) license, which 
                 in non- menopausal women. Asbaghi and colleagues                                                             permits others to distribute, remix, adapt, build upon this work non-commercially                , 
                 found that magnesium supplementation did not affect                                                          and license their derivative works on different terms, provided the original work is 
                                                                                                       35
                 body weight, BMI and WC, while Askari et al  found                                                           properly cited, appropriate credit is given, any changes made indicated, and the use 
                 a significant reduction in BMI following magnesium                                                           is non- commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
                                                                               36
                 supplementation and Rafiee et al  found that magne-                                                          ORCID iDs
                 sium supplementation was associated with lower WC only                                                       Shunlian Fu http://orcid.org/0000-0003-2002-6606
                 in obese subjects.                                                                                           Qian Zhou http://orcid.org/0000-0001-6957-9821
                     Generally, interventional studies that investigate the 
                 relationship between food intake and obesity-related                                                                                                                                                                        http://bmjopen.bmj.com/
                 anthropometric characteristics are often performed                                                           REFERENCES
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...Open access protocol effects of diet on obesity related bmj first published as bmjopen january downloaded from anthropometric characteristics in adults a for an umbrella review meta analyses randomised controlled trials shunlian fu qian zhou lijun yuan zinan li qiu chen to cite s q l abstract strengths and limitations this study et al introduction there have been many the influence different diets included outcomes contain comprehensive however whether interventions can effectively range rela ted character decrease istics possible remains unclear objective is substantial number original research papers e doi participants are summarise synthesise evidence paper covers types food comprehensively prepublication history additional supplemental material by we will try address heterogeneity available systematic reviews online view these files methods analysis retrieve english be limited including only please visit journal articles before december full texts language http dx org searching pub...

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