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Danone Institute International Providing consultancy and research in health economics for the NHS, pharmaceutical and health care industries since 1986 DANONE INSTITUTE INTERNATIONAL Systematic Review of Yoghurt for Weight Management Outcomes Final Protocol JULIE GLANVILLE, Associate Director JAQUI EALES,Associate HANNAH WOOD, Information Specialist 26 SEPTEMBER 2014 Contents Page No. Acknowledgements Abbreviations Section 1: Introduction 2 1.1 Defining Yoghurt 2 Section 2: Objectives 4 Section 3: Methods 5 3.1 Research Question 5 3.2 Search Strategy 8 3.3 Selection of Eligible Studies 11 3.4 Data Extraction 11 3.5 Quality Assessment 12 3.6 Data synthesis 12 Section 4: Report 14 4.1 Draft Report 14 4.2 Final Report 14 Section 5: Timeline 15 References Appendices: Appendix A: PRISMA flow diagram Appendix B: PRISMA checklist Appendix C: Protocol changes All reasonable precautions have been taken by YHEC to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall YHEC be liable for damages arising from its use. Abbreviations BMI Body mass index CI Confidence interval CRD Centre for reviews and dissemination DII Danone Institute International EFSA European food safety authority HRQoL Health-related quality of life OR Odds ratio PRISMA Preferred Reporting Items for Systematic Reviews and Meta-Analyses SR Systematic review RCT Randomized control trial RR Risk ratio WMD Weighted mean difference YHEC York Health Economics Consortium i Section 1: Introduction York Health Economics Consortium (YHEC) has been commissioned by Danone Institute International (DII) to conduct a systematic review (SR) of the effect of yoghurt consumption on weight management outcomes. This document is the protocol for this work, and sets out how YHEC will approach this task and its constituent tasks. 1.1 DEFINING YOGHURT The Codex Alimentarius international food standards define yoghurt as a form of fermented milk that contains symbiotic cultures of Streptococcus thermophiles and Lactobacillus delbrueckii subsp. Bulgaricus. To be called a yoghurt a fermented milk product must contain milk protein, milk fat, lactic acid, ethanol, microorganisms and yeasts in the proper proportions (Table 1)(1). Probiotic yogurt is differentiated from conventional yoghurt through the addition of further strains of probiotic bacteria (2). This review focuses on the effectiveness of yoghurt containing the symbiotic cultures Streptococcus thermophiles and Lactobacillus delbrueckii subsp. Bulgaricus, as defined by the Codex Alimentarius. Table 1: The composition of fermented milk products (1) Fermented Milk Yoghurt, Alternate Kefir Kumys Culture Yoghurt and Acidophilus milk Milk protein Min. 2.7% Min. 2.7% Min. 2.7% Milk fat Less than 10% Less than 15% Less than 10% Less than 10% Titrable acidity, Min. 0.3% Min. 0.6% Min. 0.6% Min. 0.7% expressed as % lactic acid (%m/m) Ethanol(% vol/w) Min. 0.5% Sum of Min. 107 Min. 107 Min. 107 Min. 107 microorganisms constituting the starter culture (cfu/g, In total) Labelled Min. 106 Min. 106 microorganisms (cfu.g, total) Yeasts (cfu/g) Min. 104 Min. 104 Vol. = volume; cfu/g = colony-forming units per gram; Min. = minimum. The beneficial health effects of yoghurt have been the subject of investigation for over a century. A range of research designs have been employed in the construction of an international evidence base, including observational studies and experimental studies (3, 4). The efficacy of yoghurt has been investigated in relation to a wide range of separate and Section 1 2 overlapping outcomes including weight management (5), type 2 diabetes (6), cardio-vascular disease risk (7), bone health (8), dental health (9), the risk of various forms of cancer (10), gastro-intestinal health (11), diarrhoea symptoms (12), lactose intolerance (13), malnutrition (14), immunological parameters(15), and overall mortality (16). Meta-analyses and systematic reviews have been conducted in relation to only a few of these outcomes. Their limited results suggest that consuming yoghurt may reduce the risk of developing type 2 diabetes (17-19), but may have no effect on the risk of developing colorectal cancer (20), hypertension (21) or on overall mortality (22). In recent years considerable attention has been paid to understanding the health benefits of probiotic yoghurts, with increasing numbers of systematic reviews having been conducted in this area. DII now wish to conduct a systematic review of the effect of standard yoghurt consumption on outcomes related to weight management. There is particular interest in identifying data for specific subgroups of the general apparently healthy adult population, such as those at risk of diabetes, and for investigating the effects in different ethnic groups. Section 1 3 Section 2: Objectives The objective of this project is to produce a systematic review of the effect of standard yoghurt consumption on weight management outcomes. Section 2 4 Section 3: Methods A systematic review involves the systematic and transparent identification, selection, extraction and synthesis of studies relevant to the research question (23). The first stage of this protocol is to define the research question and the inclusion and exclusion criteria (Table 3.1). 3.1 RESEARCH QUESTION To be included in the systematic review, studies must meet all of the following inclusion criteria. 3.1.1 Study types Relevant comparative studies will be limited to the following study types: Randomized controlled trials (RCTs) including quasi-RCTs; Controlled clinical trials; Comparative observational studies (including cross sectional studies, cohort studies and case control studies). Studies with relevant comparative designs published as abstracts, conference presentations or unpublished reports will be included in the review if they report all items from Section 3.1. Trial protocols, where the study results have not yet been reported, will be noted in a table of forthcoming studies. We will examine any relevant systematic reviews of evidence on the effects of yoghurt on weight management outcomes to identify any additional studies that might be eligible to be included in the systematic review. The following non-comparative study designs will not be eligible for inclusion: Case reports; Case series. Letters, comments and editorials and studies not published in English will not be eligible for inclusion in the systematic review. 3.1.2 Participants To be included in the review eligible studies will examine the effects of yoghurt on weight management in the apparently healthy adult population (18-65 years). Studies that contain a Section 3 5 mixed population with a proportion of the population aged over 65 years of age or younger than 18 will be treated as eligible if there are separate results presented for the 18-65 age group. Studies that contain a mixed population with a proportion of the population aged over 65 years of age will be treated as eligible, if there is a total of 20% or less of the study population who are either aged 65 or younger than 18 years of age. Studies reporting data for specific subgroups of the general population who are at high risk will also be eligible, for example people with insulin resistance, diabetes or obesity (BMI between 30 and 40). Studies only examining the effects of yoghurt on weight management in the following populations will be excluded: Study populations comprising only people with severe or morbid obesity (BMI ≥40.00)1; Study populations with a single specific disease or symptom such as anaemia, which are not representative of the apparently healthy general population; People training for or undertaking physical activity at a professional level (e.g. professional sports people, soldiers or fire service personnel); Any animal population; In vitro studies; Studies using technologies that mimic stomachs. 3.1.3 Interventions Studies eligible for inclusion in this review will include the following interventions: Yoghurt, or any of its synonyms (Yogurt; Yoghourt; Yaourt; Joghurt; Yogourt; Yaghourt; Yahourth; Yoghurd; Joghourt; Jogourt; Maas (Amasi); Dahi; Doi; Perugu; Thayir; Mosaru; Curd; Matsun; Matsoon; Matsoun; Matxoun; Madzoon; Madzoun; Mancun; Matson; Matsoni; Dadiah; Dadih; Stragisto). Studies will not be eligible for inclusion where yoghurt is featured as an intervention in combination with another substance (e.g. CLA/vitamins/Olibra) which is the main focus of the study. In those studies, yoghurt is being used as a carrier substance for an active ingredient and hence is not the focus of the investigation. Studies reporting the following interventions will not be eligible for inclusion: Probiotic yoghurt; Fermented milk, kefir and kumys; 1 World Health Organiszation. Global database on body mass index [web page]. Geneva: WHO; 2014. http://apps.who.int/bmi/index.jsp?introPage=intro_3.html Section 3 6 Fermented baby formula; Milk. For the purposes of this review, yoghurt which is reported to contain any bacteria other than Streptococcus thermophilius and Lactobacillus delbrueckii subsp. Bulgaricus will not be eligible for inclusion. Only studies reporting oral consumption of yoghurt will be eligible for inclusion in the review. Topical application of yoghurt as an intervention will not be eligible for inclusion. 3.1.4 Comparators Eligible studies must compare yoghurt with one or more of the following interventions:
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