The Big Breakfast Study
2019年6月19日 更新者：University of Aberdeen
Role of Breakfast Size and Composition for Appetite Control and Energy Balance
This weight loss study will investigate the impact of diet composition and meal size (large breakfast meals and smaller evening meals) on body weight, energy balance and eating behaviour, by altering calorie (meal) distribution.
研究概览
详细说明
The aim of this study is to further strengthen our understanding of the role of dietary components (in particular fibre and protein) in a healthy diet. The information gained from this research will lead to better policy advice, particularly in relation to healthy weight management, metabolic control, mental health and intestinal health. It will also lay the foundations to produce healthier primary products and aid the food industry in developing new and healthier products (e.g. products that aid hunger control and satiety). This will be addressed through four interlinked objectives:
O1: Healthy weight management and improved metabolic and mental health O2: Identification of gut bacteria and compounds of relevance to vascular and gut health O3: Linking fibre consumption to intestinal microbial communities and health O4: Mathematical modelling of interactions between diet and gut microbial communities
研究类型
介入性
注册 (实际的)
19
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
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Aberdeen、英国、AB25 2ZD
- The Rowett Institute
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
20年 至 60年 (成人)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- BMI ranging from 27-42 kg/m2;
- those habitually consuming breakfast (at least 5 times a week).
Exclusion Criteria:
- women who are pregnant, planning to be pregnant or breastfeeding
- subjects with food allergy
- diagnosis of diabetes, hypertension, renal, hepatic, haematological disease or coronary heart disease
- having given a pint of blood for transfusion purposes within the last month
- unsuitable veins for blood sampling
- inability to understand the participant information sheet
- inability to speak, read and understand the English language
- those on any prescription medications (other than oral contraceptives)
- those on any specific diet regimes
- those on any weight loss programmes (that may be affecting lifestyle, physical activity and diet).
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：High Fibre to High-Protein (HF-HP)
|
High fibre/carbohydrate (50% CHO, 35% fat and 15% Protein) with 45% calories at breakfast and 20% evening meal provided and buffet lunch.
Total dietary fibre will be at least 30g/d for 2000kcal intake and provided as a mixed soluble and insoluble fibre sources to maintain palatability of the diet (e.g.
wheat bran, fava bean, lentil, buckwheat).
其他名称：
• High protein diet (30% protein, 35% fat and 35% CHO) with 45% calories at breakfast and 20% evening meal provided and buffet lunch.
Protein will be a mixed meat matrix to include poultry, fish, red meat, prawns, eggs, dairy.
Total dietary fibre will be no more than 15g/d for 2000kcal intake.
其他名称：
|
|
实验性的：High Protein to High-Fibre (HP-HF)
|
High fibre/carbohydrate (50% CHO, 35% fat and 15% Protein) with 45% calories at breakfast and 20% evening meal provided and buffet lunch.
Total dietary fibre will be at least 30g/d for 2000kcal intake and provided as a mixed soluble and insoluble fibre sources to maintain palatability of the diet (e.g.
wheat bran, fava bean, lentil, buckwheat).
其他名称：
• High protein diet (30% protein, 35% fat and 35% CHO) with 45% calories at breakfast and 20% evening meal provided and buffet lunch.
Protein will be a mixed meat matrix to include poultry, fish, red meat, prawns, eggs, dairy.
Total dietary fibre will be no more than 15g/d for 2000kcal intake.
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Energy Balance
大体时间：measured up to day 71 of study
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Chronic influence on energy balance (body weight, kg)
|
measured up to day 71 of study
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Acute effects on appetite after test meals
大体时间：Baseline & week 4 of each treatment
|
Appetite questionnaires recorded on Visual Analogue Scales every 30mins on test days
|
Baseline & week 4 of each treatment
|
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Acute effects on biomarkers of health after test meals
大体时间：Baseline & week 4 of each treatment
|
blood samples analysed for Glucose, Lipids and Hormones
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Baseline & week 4 of each treatment
|
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Acute effects on gastric emptying after test meals
大体时间：Baseline & week 4 of each treatment
|
gastric emptying (stable isotope, Octanoic acid labelled breath samples)
|
Baseline & week 4 of each treatment
|
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Resting Metabolic Rate (RMR) before & after test meals
大体时间：Baseline & week 4 of each treatment
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Chronic influence on metabolism or Thermic Effect of Food (TEF) using indirect calorimetry measurement
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Baseline & week 4 of each treatment
|
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Faecal sample analysis for gut health
大体时间：up to 10 weeks
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Chronic influence on changes in gut microbiota
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up to 10 weeks
|
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Bone Density
大体时间：Baseline & week 4 of each treatment
|
Dual Energy X-ray Absorptiometry (DXA) Scan to measure fat mass, fat free mass & bone density as part of the 4 compartment model
|
Baseline & week 4 of each treatment
|
|
Body Composition
大体时间：Baseline & week 4 of each treatment
|
Air Displacement Plethysmography (BodPod) to measure body fat as part of the 4 compartment model
|
Baseline & week 4 of each treatment
|
|
Total Body Water
大体时间：Baseline & week 4 of each treatment
|
Deuterium Dilution to measure Total Body Water (TBW) as part of the 4 compartment model
|
Baseline & week 4 of each treatment
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Alexandra Johnstone, PhD、Senior Research Fellow
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年4月5日
初级完成 (实际的)
2019年4月5日
研究完成 (实际的)
2019年4月5日
研究注册日期
首次提交
2016年12月1日
首先提交符合 QC 标准的
2017年3月6日
首次发布 (实际的)
2017年3月10日
研究记录更新
最后更新发布 (实际的)
2019年6月20日
上次提交的符合 QC 标准的更新
2019年6月19日
最后验证
2019年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.