Clinical trial NCT03077295: The Big Breakfast Study
Official title: Role of Breakfast Size and Composition for Appetite Control and Energy Balance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Weight Loss
Lead sponsor: University of Aberdeen
Sponsor class: OTHER
First posted: 2017-03-10
Enrollment: 19
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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

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).

Primary outcomes:
measure: Change in Energy Balance
timeFrame: measured up to day 71 of study
Secondary outcomes:
measure: Acute effects on appetite after test meals
timeFrame: Baseline & week 4 of each treatment
measure: Acute effects on biomarkers of health after test meals
timeFrame: Baseline & week 4 of each treatment
measure: Acute effects on gastric emptying after test meals
timeFrame: Baseline & week 4 of each treatment
measure: Resting Metabolic Rate (RMR) before & after test meals
timeFrame: Baseline & week 4 of each treatment
measure: Faecal sample analysis for gut health
timeFrame: up to 10 weeks
measure: Bone Density
timeFrame: Baseline & week 4 of each treatment
measure: Body Composition
timeFrame: Baseline & week 4 of each treatment
measure: Total Body Water
timeFrame: Baseline & week 4 of each treatment
Other outcomes:
Locations:
city: Aberdeen
country: United Kingdom
facility: The Rowett Institute
Study officials:
affiliation: Senior Research Fellow
name: Alexandra Johnstone, PhD
role: PRINCIPAL_INVESTIGATOR
References: