The Big Breakfast Study

NCT03077295 | Completed DMC

• 1 other identifier: 804
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Weight Loss

Outcome Measures

Primary Outcomes (1)

• Change in Energy Balance

  Chronic influence on energy balance (body weight, kg)

  measured up to day 71 of study

Secondary Outcomes (8)

• Acute effects on appetite after test meals

  Baseline & week 4 of each treatment

• Acute effects on biomarkers of health after test meals

  Baseline & week 4 of each treatment

• Acute effects on gastric emptying after test meals

  Baseline & week 4 of each treatment

• Resting Metabolic Rate (RMR) before & after test meals

  Baseline & week 4 of each treatment

• Faecal sample analysis for gut health

  up to 10 weeks

Study Arms (2)

High Fibre to High-Protein (HF-HP)

EXPERIMENTAL

* 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; Other: High Protein

High Protein to High-Fibre (HP-HF)

EXPERIMENTAL

* 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; Other: High Protein

Interventions

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).

Also known as: HF

High Fibre to High-Protein (HF-HP); High Protein to High-Fibre (HP-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.

Also known as: HP

High Fibre to High-Protein (HF-HP); High Protein to High-Fibre (HP-HF)

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI ranging from 27-42 kg/m2;
• those habitually consuming breakfast (at least 5 times a week).

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Aberdeen: lead

Study Sites (1)

The Rowett Institute

Aberdeen, AB25 2ZD, United Kingdom

Location

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Alexandra Johnstone, PhD

  Senior Research Fellow

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2016
• First Posted: March 10, 2017
• Study Start: April 5, 2017
• Primary Completion: April 5, 2019
• Study Completion: April 5, 2019
• Last Updated: June 20, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)