ObesityNCT03077295
The Big Breakfast Study
A study testing High Fibre and High Protein in people with Obesity and Weight Loss, run by University of Aberdeen at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Weight Loss
- What is being tested?
- High Fibre and High Protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Apr 2017to 5 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI ranging from 27-42 kg/m2;
- those habitually consuming breakfast (at least 5 times a week).
Who cannot join
- 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
Show all 10Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Breakfast Size and Composition for Appetite Control and Energy Balance
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.
Read the 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
- Conditions
- Obesity, Weight Loss
- Being tested
- High Fibre, High Protein
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High FibreOther
Also called HF
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 ProteinOther
Also called HP
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: High Fibre; Other: High Protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Energy Balance
Chronic influence on energy balance (body weight, kg)
Measured: measured up to day 71 of study
Secondary outcomes (8)
Acute effects on appetite after test meals
Appetite questionnaires recorded on Visual Analogue Scales every 30mins on test days
Measured: Baseline & week 4 of each treatment
Acute effects on biomarkers of health after test meals
blood samples analysed for Glucose, Lipids and Hormones
Measured: Baseline & week 4 of each treatment
Acute effects on gastric emptying after test meals
gastric emptying (stable isotope, Octanoic acid labelled breath samples)
Measured: Baseline & week 4 of each treatment
Resting Metabolic Rate (RMR) before & after test meals
Chronic influence on metabolism or Thermic Effect of Food (TEF) using indirect calorimetry measurement
Measured: Baseline & week 4 of each treatment
Faecal sample analysis for gut health
Chronic influence on changes in gut microbiota
Measured: up to 10 weeks
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
Measured: Baseline & week 4 of each treatment
Body Composition
Air Displacement Plethysmography (BodPod) to measure body fat as part of the 4 compartment model
Measured: Baseline & week 4 of each treatment
Total Body Water
Deuterium Dilution to measure Total Body Water (TBW) as part of the 4 compartment model
Measured: Baseline & week 4 of each treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2017
- Study start5 Apr 2017
- Primary completion5 Apr 2019
- Study completion5 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandra Johnstone, PhD, Principal investigator, Senior Research Fellow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03077295
- Sponsor's protocol ID
- 804
- Status last verified
- Jun 2019
- First submitted
- 1 Dec 2016
- Last updated
- 20 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Breakfast Size and Composition for Appetite Control and Energy Balance
- ClinicalTrials.gov ID
- NCT03077295
- Acronym / sponsor ID
- 804
- Conditions
- Obesity, Weight Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Study start
- 5 Apr 2017 (actual)
- Primary completion
- 5 Apr 2019 (actual)
- Study completion
- 5 Apr 2019 (actual)
- First posted
- 10 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Fibre to High-Protein (HF-HP) | Experimental | Other: High Fibre, Other: High Protein* 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 |
| High Protein to High-Fibre (HP-HF) | Experimental | Other: High Fibre, Other: High Protein* 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 |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI ranging from 27-42 kg/m2;
- those habitually consuming breakfast (at least 5 times a week).
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High FibreAlso: HFHigh 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 | High Fibre to High-Protein (HF-HP), High Protein to High-Fibre (HP-HF) |
| High ProteinAlso: HP• 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 | High Fibre to High-Protein (HF-HP), High Protein to High-Fibre (HP-HF) |
Primary outcome
Change in Energy Balance
Time frame: measured up to day 71 of study
Chronic influence on energy balance (body weight, kg)
8 secondary outcomes
Acute effects on appetite after test meals
Time frame: Baseline & week 4 of each treatment
Acute effects on biomarkers of health after test meals
Time frame: Baseline & week 4 of each treatment
Acute effects on gastric emptying after test meals
Time frame: Baseline & week 4 of each treatment
Resting Metabolic Rate (RMR) before & after test meals
Time frame: Baseline & week 4 of each treatment
Faecal sample analysis for gut health
Time frame: up to 10 weeks
Bone Density
Time frame: Baseline & week 4 of each treatment
Body Composition
Time frame: Baseline & week 4 of each treatment
Total Body Water
Time frame: Baseline & week 4 of each treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandra Johnstone, PhD principal investigator
Senior Research Fellow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Fibre and High Protein in people with Obesity and Weight Loss, run by University of Aberdeen at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Energy Balance (time frame: measured up to day 71 of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2019; AzTrials last refreshed its copy on 27 Oct 2026.