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The Big Breakfast Study

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03077295
Enrollment
19
Registered
2017-03-10
Start date
2017-04-05
Completion date
2019-04-05
Last updated
2019-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Weight Loss

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

Interventions

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 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.

Sponsors

University of Aberdeen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
Change in Energy Balancemeasured up to day 71 of studyChronic influence on energy balance (body weight, kg)

Secondary

MeasureTime frameDescription
Acute effects on biomarkers of health after test mealsBaseline & week 4 of each treatmentblood samples analysed for Glucose, Lipids and Hormones
Acute effects on gastric emptying after test mealsBaseline & week 4 of each treatmentgastric emptying (stable isotope, Octanoic acid labelled breath samples)
Resting Metabolic Rate (RMR) before & after test mealsBaseline & week 4 of each treatmentChronic influence on metabolism or Thermic Effect of Food (TEF) using indirect calorimetry measurement
Acute effects on appetite after test mealsBaseline & week 4 of each treatmentAppetite questionnaires recorded on Visual Analogue Scales every 30mins on test days
Bone DensityBaseline & week 4 of each treatmentDual Energy X-ray Absorptiometry (DXA) Scan to measure fat mass, fat free mass & bone density as part of the 4 compartment model
Body CompositionBaseline & week 4 of each treatmentAir Displacement Plethysmography (BodPod) to measure body fat as part of the 4 compartment model
Total Body WaterBaseline & week 4 of each treatmentDeuterium Dilution to measure Total Body Water (TBW) as part of the 4 compartment model
Faecal sample analysis for gut healthup to 10 weeksChronic influence on changes in gut microbiota

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026