Role of Breakfast Size and Composition for Appetite Control and Energy Balance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Change in Energy Balance
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI ranging from 27-42 kg/m2;
- •those habitually consuming breakfast (at least 5 times a week).
排除标准
- •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).
研究组 & 干预措施
High Fibre to High-Protein (HF-HP)
- Phase 1: no intervention, habitual diet for 4 days and then 3day maintenance diet
- Phase 2: consumption of HF meals for 4 weeks
- Phase 3: washout for 1 week, controlled maintenance diet
- Phase 4: consumption of HP meals for 4 weeks
干预措施: High Fibre (Other)
High Fibre to High-Protein (HF-HP)
- Phase 1: no intervention, habitual diet for 4 days and then 3day maintenance diet
- Phase 2: consumption of HF meals for 4 weeks
- Phase 3: washout for 1 week, controlled maintenance diet
- Phase 4: consumption of HP meals for 4 weeks
干预措施: High Protein (Other)
High Protein to High-Fibre (HP-HF)
- Phase 1: no intervention, habitual diet for 4 days and then 3day maintenance diet
- Phase 2: consumption of HP meals for 4 weeks
- Phase 3: washout for 1 week, controlled maintenance diet
- Phase 4: consumption of HF meals for 4 weeks
干预措施: High Fibre (Other)
High Protein to High-Fibre (HP-HF)
- Phase 1: no intervention, habitual diet for 4 days and then 3day maintenance diet
- Phase 2: consumption of HP meals for 4 weeks
- Phase 3: washout for 1 week, controlled maintenance diet
- Phase 4: consumption of HF meals for 4 weeks
干预措施: High Protein (Other)
结局指标
主要结局
Change in Energy Balance
时间窗: measured up to day 71 of study
Chronic influence on energy balance (body weight, kg)
次要结局
- Acute effects on biomarkers of health after test meals(Baseline & week 4 of each treatment)
- Faecal sample analysis for gut health(up to 10 weeks)
- Acute effects on appetite after test meals(Baseline & week 4 of each treatment)
- Bone Density(Baseline & week 4 of each treatment)
- Acute effects on gastric emptying after test meals(Baseline & week 4 of each treatment)
- Resting Metabolic Rate (RMR) before & after test meals(Baseline & week 4 of each treatment)
- Total Body Water(Baseline & week 4 of each treatment)
- Body Composition(Baseline & week 4 of each treatment)