The Big Breakfast Study

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Weight Loss
• Intervention / Treatment: Other: High Fibre; Other: High Protein

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

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Aberdeen, United Kingdom, AB25 2ZD
    • The Rowett Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: 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).; Other Names: HF; 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.; Other Names: HP
Experimental: 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	Other: 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).; Other Names: HF; 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.; Other Names: HP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Energy Balance	Chronic influence on energy balance (body weight, kg)	measured up to day 71 of study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute effects on appetite after test meals	Appetite questionnaires recorded on Visual Analogue Scales every 30mins on test days	Baseline & week 4 of each treatment
Acute effects on biomarkers of health after test meals	blood samples analysed for Glucose, Lipids and Hormones	Baseline & week 4 of each treatment
Acute effects on gastric emptying after test meals	gastric emptying (stable isotope, Octanoic acid labelled breath samples)	Baseline & week 4 of each treatment
Resting Metabolic Rate (RMR) before & after test meals	Chronic influence on metabolism or Thermic Effect of Food (TEF) using indirect calorimetry measurement	Baseline & week 4 of each treatment
Faecal sample analysis for gut health	Chronic influence on changes in gut microbiota	up to 10 weeks
Bone Density	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	Air Displacement Plethysmography (BodPod) to measure body fat as part of the 4 compartment model	Baseline & week 4 of each treatment
Total Body Water	Deuterium Dilution to measure Total Body Water (TBW) as part of the 4 compartment model	Baseline & week 4 of each treatment

Collaborators and Investigators

• Sponsor: University of Aberdeen
• Investigators: Principal Investigator: Alexandra Johnstone, PhD, Senior Research Fellow

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2017
• Primary Completion (Actual): April 5, 2019
• Study Completion (Actual): April 5, 2019

Study Registration Dates

• First Submitted: December 1, 2016
• First Submitted That Met QC Criteria: March 6, 2017
• First Posted (Actual): March 10, 2017

Study Record Updates

• Last Update Posted (Actual): June 20, 2019
• Last Update Submitted That Met QC Criteria: June 19, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: 804

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No