The Big Breakfast Study
- Conditions
- Weight LossObesity
- Interventions
- Other: High FibreOther: High Protein
- Registration Number
- NCT03077295
- Lead Sponsor
- University of Aberdeen
- Brief Summary
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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19
- BMI ranging from 27-42 kg/m2;
- those habitually consuming breakfast (at least 5 times a week).
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description High Fibre to High-Protein (HF-HP) High Fibre * 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 High Protein to High-Fibre (HP-HF) High Protein * 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 High Protein to High-Fibre (HP-HF) High Fibre * 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 High Fibre to High-Protein (HF-HP) High Protein * 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
- Primary Outcome Measures
Name Time Method Change in Energy Balance measured up to day 71 of study Chronic influence on energy balance (body weight, kg)
- Secondary Outcome Measures
Name Time Method Body Composition Baseline & week 4 of each treatment Air Displacement Plethysmography (BodPod) to measure body fat as part of the 4 compartment model
Acute effects on biomarkers of health after test meals Baseline & week 4 of each treatment blood samples analysed for Glucose, Lipids and Hormones
Faecal sample analysis for gut health up to 10 weeks Chronic influence on changes in gut microbiota
Acute effects on appetite after test meals Baseline & week 4 of each treatment Appetite questionnaires recorded on Visual Analogue Scales every 30mins on test days
Bone Density 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
Acute effects on gastric emptying after test meals Baseline & week 4 of each treatment gastric emptying (stable isotope, Octanoic acid labelled breath samples)
Resting Metabolic Rate (RMR) before & after test meals Baseline & week 4 of each treatment Chronic influence on metabolism or Thermic Effect of Food (TEF) using indirect calorimetry measurement
Total Body Water Baseline & week 4 of each treatment Deuterium Dilution to measure Total Body Water (TBW) as part of the 4 compartment model
Trial Locations
- Locations (1)
The Rowett Institute
🇬🇧Aberdeen, United Kingdom