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The Big Breakfast Study

Primary Purpose

Obesity, Weight Loss

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
High Fibre
High Protein
Sponsored by
University of Aberdeen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • The Rowett Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

High Fibre to High-Protein (HF-HP)

High Protein to High-Fibre (HP-HF)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in Energy Balance
Chronic influence on energy balance (body weight, kg)

Secondary Outcome Measures

Acute effects on appetite after test meals
Appetite questionnaires recorded on Visual Analogue Scales every 30mins on test days
Acute effects on biomarkers of health after test meals
blood samples analysed for Glucose, Lipids and Hormones
Acute effects on gastric emptying after test meals
gastric emptying (stable isotope, Octanoic acid labelled breath samples)
Resting Metabolic Rate (RMR) before & after test meals
Chronic influence on metabolism or Thermic Effect of Food (TEF) using indirect calorimetry measurement
Faecal sample analysis for gut health
Chronic influence on changes in gut microbiota
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
Body Composition
Air Displacement Plethysmography (BodPod) to measure body fat as part of the 4 compartment model
Total Body Water
Deuterium Dilution to measure Total Body Water (TBW) as part of the 4 compartment model

Full Information

First Posted
December 1, 2016
Last Updated
June 19, 2019
Sponsor
University of Aberdeen
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1. Study Identification

Unique Protocol Identification Number
NCT03077295
Brief Title
The Big Breakfast Study
Official Title
Role of Breakfast Size and Composition for Appetite Control and Energy Balance
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
April 5, 2017 (Actual)
Primary Completion Date
April 5, 2019 (Actual)
Study Completion Date
April 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aberdeen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Weight Loss

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Fibre to High-Protein (HF-HP)
Arm Type
Experimental
Arm Description
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
Arm Title
High Protein to High-Fibre (HP-HF)
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
High Fibre
Other Intervention Name(s)
HF
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
High Protein
Other Intervention Name(s)
HP
Intervention Description
• 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.
Primary Outcome Measure Information:
Title
Change in Energy Balance
Description
Chronic influence on energy balance (body weight, kg)
Time Frame
measured up to day 71 of study
Secondary Outcome Measure Information:
Title
Acute effects on appetite after test meals
Description
Appetite questionnaires recorded on Visual Analogue Scales every 30mins on test days
Time Frame
Baseline & week 4 of each treatment
Title
Acute effects on biomarkers of health after test meals
Description
blood samples analysed for Glucose, Lipids and Hormones
Time Frame
Baseline & week 4 of each treatment
Title
Acute effects on gastric emptying after test meals
Description
gastric emptying (stable isotope, Octanoic acid labelled breath samples)
Time Frame
Baseline & week 4 of each treatment
Title
Resting Metabolic Rate (RMR) before & after test meals
Description
Chronic influence on metabolism or Thermic Effect of Food (TEF) using indirect calorimetry measurement
Time Frame
Baseline & week 4 of each treatment
Title
Faecal sample analysis for gut health
Description
Chronic influence on changes in gut microbiota
Time Frame
up to 10 weeks
Title
Bone Density
Description
Dual Energy X-ray Absorptiometry (DXA) Scan to measure fat mass, fat free mass & bone density as part of the 4 compartment model
Time Frame
Baseline & week 4 of each treatment
Title
Body Composition
Description
Air Displacement Plethysmography (BodPod) to measure body fat as part of the 4 compartment model
Time Frame
Baseline & week 4 of each treatment
Title
Total Body Water
Description
Deuterium Dilution to measure Total Body Water (TBW) as part of the 4 compartment model
Time Frame
Baseline & week 4 of each treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandra Johnstone, PhD
Organizational Affiliation
Senior Research Fellow
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Rowett Institute
City
Aberdeen
ZIP/Postal Code
AB25 2ZD
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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The Big Breakfast Study

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