- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03305237
The Meal Time Study
The Big Breakfast Study: Chrono-nutrition Influence on Energy Expenditure and Body Weight
This weight loss study will investigate the impact of calorie distribution across a day (large breakfast meals and smaller evening meals versus small breakfast meals and large evening meals) on body weight, and physiological and behavioral mechanisms regulating energy balance.
Participants will undergo 2 x 4 week energy restriction protocols in a randomized cross over design; big breakfast (45% of calories in the morning meal, 20% at dinner) and big dinner (45% of calories in the evening meal, 20% at breakfast). We predict that timing of eating will influence energy balance, because morning energy expenditure is amplified in comparison to the evening. This study will allow us to assess whether the increased energy expenditure in the morning is linked to natural biological circadian rhythm or behavioral adaptions.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Dietary advice for weight management is broadly based on the assumption that a 'calorie is a calorie' and it does not matter when calories are consumed across the day. Recent evidence has challenged this assumption, suggesting that we may utilize calories more efficiently when consumed in the morning relative to the evening, and this could be used as a beneficial strategy for weight loss - this is a newly developing field of investigation which merges circadian biology with nutrition (chrono-nutrition).
Timing of food consumption is a modifiable factor influencing energy balance and body weight (and thus, disease risk). Previous research has shown that calories ingested at different times of the day have different effects on energy utilization, leading to differential weight loss, even at iso-caloric amounts. This study will aim to increase our understanding of the underlying behavioral and physiological mechanisms associated with differential weight loss and energy balance when calories are consumed predominantly in the morning versus in the evening.
This study will be a cross-over study comparing large breakfast versus large evening meals (percent daily calories split between breakfast, lunch and dinner as 45-35-20 (breakfast-loaded) or 20-35-45 (evening-loaded)) during energy restriction (Fed to measured RMR) on energy balance, through differences in both physiological and behavioural changes in energy expenditure and substrate utilization.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Aberdeen, United Kingdom, AB25 2ZD
- The Rowett Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 allergies which prevent consumption of the study diet.
- diagnosis of diabetes, hypertension, renal, hepatic, haematological disease, coronary heart disease, metabolic disease, gastrointestinal 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) which will adversely affect the study outcomes (i.e. medications affecting, circadian timing, sleep or metabolic function).
- those on any specific diet regimes
- those on any weight loss programmes (that may be affecting lifestyle, physical activity and diet).
- Extremes of chronotypes, sleep patterns and physical activity.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: big breakfast (BB) to big dinner (BD)
Phase 1: no intervention, habitual diet for 4 days and then 4day maintenance diet Phase 2: consumption of BB energy restriction diets for 4 weeks Phase 3: washout for 1 week, controlled maintenance diet Phase 4: consumption of BD energy restriction diets for 4 weeks
|
Weight loss diet (Calories fed to measured RMR) with calories distributed predominantly at breakfast (percent daily calories split between breakfast, lunch and dinner as 45-35-20%).
The diet will be high protein (30% protein, 35% fat and 35% CHO) with all meals provided.
Weight loss diet (Calories fed to measured RMR) with calories distributed predominantly at dinner (percent daily calories split between breakfast, lunch and dinner as 20-35-45%).
The diet will be high protein (30% protein, 35% fat and 35% CHO) with all meals provided.
|
EXPERIMENTAL: big dinner (BD) to big breakfast (BB)
Phase 1: no intervention, habitual diet for 4 days and then 4day maintenance diet Phase 2: consumption of BD energy restriction diets for 4 weeks Phase 3: washout for 1 week, controlled maintenance diet Phase 4: consumption of BB energy restriction diets for 4 weeks
|
Weight loss diet (Calories fed to measured RMR) with calories distributed predominantly at breakfast (percent daily calories split between breakfast, lunch and dinner as 45-35-20%).
The diet will be high protein (30% protein, 35% fat and 35% CHO) with all meals provided.
Weight loss diet (Calories fed to measured RMR) with calories distributed predominantly at dinner (percent daily calories split between breakfast, lunch and dinner as 20-35-45%).
The diet will be high protein (30% protein, 35% fat and 35% CHO) with all meals provided.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Energy balance
Time Frame: Measured up to day 71 of study
|
Change in energy balance during each diet protocol (body weight (kg))
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Measured up to day 71 of study
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total Daily Energy Expenditure
Time Frame: 4 x 2 weeks. Throughout weeks 2-5 and 7-10.
|
Total energy expenditure measured by DLW for the 4 week BB and BD diet phases
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4 x 2 weeks. Throughout weeks 2-5 and 7-10.
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Resting Metabolic Rate (RMR)
Time Frame: Baseline,week 1, week 5, week 6, week 10.
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RMR measured with indirect calorimetry (ventilated hood)
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Baseline,week 1, week 5, week 6, week 10.
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Thermic effect of food (TEF)
Time Frame: Week 1, week 5, week 6, week 10.
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TEF measured with indirect calorimetry (ventilated hood) for 6 hours after a breakfast meal
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Week 1, week 5, week 6, week 10.
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Body Volume
Time Frame: Week 1, week 5, week 6, week 10.
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Measured with Air Displacement plethysmography (BODPOD),
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Week 1, week 5, week 6, week 10.
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Bone Mineral Content
Time Frame: Week 1, week 5, week 6, week 10.
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Measured with Dual energy x-ray absorptiometry (DEXA)
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Week 1, week 5, week 6, week 10.
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Total Body Water
Time Frame: Week 1, week 5, week 6, week 10.
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Measured with deuterium dilution
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Week 1, week 5, week 6, week 10.
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Body Composition
Time Frame: Week 1, week 5, week 6, week 10.
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4 compartment model to assess changes in body composition (Combined from the measures of body weight, body volume, total body water and bone mineral)
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Week 1, week 5, week 6, week 10.
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Gastric emptying
Time Frame: Week 1, week 5, week 6, week 10.
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Gastric emptying measured using stable isotope, Octanoic acid labelled breath samples.
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Week 1, week 5, week 6, week 10.
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Waist and hip circumference
Time Frame: Week 1, week 5, week 6, week 10.
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Change in waist and hip circumferences and waist to hip ratio
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Week 1, week 5, week 6, week 10.
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Gut appetite hormones
Time Frame: Week 1, week 5, week 6, week 10.
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Change in plasma fasting and 2 hr post-meal appetite hormones
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Week 1, week 5, week 6, week 10.
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Plasma glucose
Time Frame: Week 1, week 5, week 6, week 10.
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Change in plasma fasting and 2 hr post-meal glucose
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Week 1, week 5, week 6, week 10.
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Plasma insulin
Time Frame: Week 1, week 5, week 6, week 10.
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Change in plasma fasting and 2 hr post-meal insulin
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Week 1, week 5, week 6, week 10.
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Blood lipids
Time Frame: Week 1, week 5, week 6, week 10.
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Change in plasma fasting and 2 hr post-meal blood lipids
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Week 1, week 5, week 6, week 10.
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Daily Subjective Appetite
Time Frame: Hourly measures for 3 days in week 1,week 5, week 6, week 10.
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Changes in subjective appetite (hunger, fullness, desire to eat) measured using visual analogue scale questionnaires every waking hour for 3 days.
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Hourly measures for 3 days in week 1,week 5, week 6, week 10.
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Postprandial Subjective Appetite
Time Frame: Week 1, week 5, week 6, week 10.
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Changes in subjective appetite (hunger, fullness, desire to eat) measured using visual analogue scale questionnaires every 30 minutes for 6 hours after test meals.
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Week 1, week 5, week 6, week 10.
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Faecal sample analysis for gut health
Time Frame: Week 1, week 5, week 6, week 10.
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Chronic influence on changes in gut microbiota
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Week 1, week 5, week 6, week 10.
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Physical activity
Time Frame: Measured continuously for 24 hours for 3 days in week 1,week 5, week 6, week 10.
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Change in physical activity levels measured with accelerometer (actigraph)
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Measured continuously for 24 hours for 3 days in week 1,week 5, week 6, week 10.
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24 hour blood glucose
Time Frame: Measured continuously for 24 hours for 3 days in week 1,week 5, week 6, week 10.
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Changes in 24 hour blood glucose levels measured with a continuous glucose monitor
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Measured continuously for 24 hours for 3 days in week 1,week 5, week 6, week 10.
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 806
- MR/P012205/1 (OTHER_GRANT: Medical Research Council)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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