The Big Breakfast Study

University of Aberdeen

Status: Completed

Conditions: Weight Loss; Obesity

Treatments: Other: High Protein; Other: High Fibre

Study type: Interventional

Funder types: Other

Identifiers

NCT03077295

804

Details and patient eligibility

About

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.

Full 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

Enrollment: 19 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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19 participants in 2 patient groups

High Fibre to High-Protein (HF-HP)

Experimental group

Description:

* 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

Treatment:

Other: High Fibre

Other: High Protein

High Protein to High-Fibre (HP-HF)

Experimental group

Description:

* 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

Treatment:

Other: High Fibre

Other: High Protein