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The Big Breakfast Study

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ClinicalTrials.gov Identifier: NCT03077295
Recruitment Status : Completed
First Posted : March 10, 2017
Last Update Posted : June 20, 2019
Sponsor:
Information provided by (Responsible Party):
University of Aberdeen

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.

Condition or disease Intervention/treatment Phase
Obesity Weight Loss Other: High Fibre Other: High Protein Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Role of Breakfast Size and Composition for Appetite Control and Energy Balance
Actual Study Start Date : April 5, 2017
Actual Primary Completion Date : April 5, 2019
Actual Study Completion Date : April 5, 2019

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: 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 Name: HP




Primary Outcome Measures :
  1. Change in Energy Balance [ Time Frame: measured up to day 71 of study ]
    Chronic influence on energy balance (body weight, kg)


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03077295


Locations
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United Kingdom
The Rowett Institute
Aberdeen, United Kingdom, AB25 2ZD
Sponsors and Collaborators
University of Aberdeen
Investigators
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Principal Investigator: Alexandra Johnstone, PhD Senior Research Fellow

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Responsible Party: University of Aberdeen
ClinicalTrials.gov Identifier: NCT03077295     History of Changes
Other Study ID Numbers: 804
First Posted: March 10, 2017    Key Record Dates
Last Update Posted: June 20, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms