The Big Breakfast Study

NCT ID: NCT03077295

Last Updated: 2019-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-05
• Study Completion Date: 2019-04-05

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

Conditions

Obesity; Weight Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

High Fibre

Intervention Type: OTHER

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).

High Protein

Intervention Type: OTHER

• 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.

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

Group Type: EXPERIMENTAL

High Fibre

Intervention Type: OTHER

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).

High Protein

Intervention Type: OTHER

• 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.

Interventions

High Fibre

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).

Intervention Type: OTHER

High Protein

• 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.

Intervention Type: OTHER

Other Intervention Names

HF; HP

Eligibility Criteria

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).

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Aberdeen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexandra Johnstone, PhD

Role: PRINCIPAL_INVESTIGATOR

Senior Research Fellow

Locations

The Rowett Institute

Aberdeen, , United Kingdom

Countries

United Kingdom

Other Identifiers

804

Identifier Type: -

Identifier Source: org_study_id