The Big Breakfast Study

Obesity Clinical Trial

Official title:

Role of Breakfast Size and Composition for Appetite Control and Energy Balance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03077295
• Other study ID #: 804
• Status: Completed
• Phase: N/A
• Start date: April 5, 2017
• Est. completion date: April 5, 2019

Study information

• Verified date: June 2019
• Source: University of Aberdeen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: April 5, 2019
• Est. primary completion date: April 5, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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).

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

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).
• 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.

Locations

Country	Name	City	State
United Kingdom	The Rowett Institute	Aberdeen

Sponsors (1)

Lead Sponsor	Collaborator
University of Aberdeen

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Energy Balance	Chronic influence on energy balance (body weight, kg)	measured up to day 71 of study
Secondary	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
Secondary	Acute effects on biomarkers of health after test meals	blood samples analysed for Glucose, Lipids and Hormones	Baseline & week 4 of each treatment
Secondary	Acute effects on gastric emptying after test meals	gastric emptying (stable isotope, Octanoic acid labelled breath samples)	Baseline & week 4 of each treatment
Secondary	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
Secondary	Faecal sample analysis for gut health	Chronic influence on changes in gut microbiota	up to 10 weeks
Secondary	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
Secondary	Body Composition	Air Displacement Plethysmography (BodPod) to measure body fat as part of the 4 compartment model	Baseline & week 4 of each treatment
Secondary	Total Body Water	Deuterium Dilution to measure Total Body Water (TBW) as part of the 4 compartment model	Baseline & week 4 of each treatment