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Completed

NCT Number: NCT03077295

The Big Breakfast Study

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.

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Key information

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Rowett Institute

Aberdeen, AB25 2ZD, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

High Fibre

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).

Other names: HF

HIgh Protein

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.

Other names: HP

Primary outcomes

  1. Change in Energy Balance

    Time frame: measured up to day 71 of study

    Chronic influence on energy balance (body weight, kg)

Secondary outcomes

  1. Acute effects on appetite after test meals

    Time frame: Baseline & week 4 of each treatment

    Appetite questionnaires recorded on Visual Analogue Scales every 30mins on test days

  2. Acute effects on biomarkers of health after test meals

    Time frame: Baseline & week 4 of each treatment

    blood samples analysed for Glucose, Lipids and Hormones

  3. Acute effects on gastric emptying after test meals

    Time frame: Baseline & week 4 of each treatment

    gastric emptying (stable isotope, Octanoic acid labelled breath samples)

  4. Resting Metabolic Rate (RMR) before & after test meals

    Time frame: Baseline & week 4 of each treatment

    Chronic influence on metabolism or Thermic Effect of Food (TEF) using indirect calorimetry measurement

  5. Faecal sample analysis for gut health

    Time frame: up to 10 weeks

    Chronic influence on changes in gut microbiota

  6. Bone Density

    Time frame: Baseline & week 4 of each treatment

    Dual Energy X-ray Absorptiometry (DXA) Scan to measure fat mass, fat free mass & bone density as part of the 4 compartment model

  7. Body Composition

    Time frame: Baseline & week 4 of each treatment

    Air Displacement Plethysmography (BodPod) to measure body fat as part of the 4 compartment model

  8. Total Body Water

    Time frame: Baseline & week 4 of each treatment

    Deuterium Dilution to measure Total Body Water (TBW) as part of the 4 compartment model

Sponsors and collaborators

Lead sponsor

University of Aberdeen

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 10, 2017
Registry last updated
Jun 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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