The Meal Time Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Big Breakfast Study: Chrono-nutrition Influence on Energy Expenditure and Body Weight

Conditions
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Obesity, Weight Loss

Intervention / Treatment
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* Other: Big Breakfast
* Other: Big Dinner


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: big breakfast (BB) to big dinner (BD)<br>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 | Other: Big Breakfast<br>* 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.<br>Other: Big Dinner<br>* 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.<br>|
| Experimental: big dinner (BD) to big breakfast (BB)<br>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 | Other: Big Breakfast<br>* 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.<br>Other: Big Dinner<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Energy balance | Change in energy balance during each diet protocol (body weight (kg)) | Measured up to day 71 of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Daily Energy Expenditure | Total energy expenditure measured by DLW for the 4 week BB and BD diet phases | 4 x 2 weeks. Throughout weeks 2-5 and 7-10. | 
| Resting Metabolic Rate (RMR) | RMR measured with indirect calorimetry (ventilated hood) | Baseline,week 1, week 5, week 6, week 10. | 
| Thermic effect of food (TEF) | TEF measured with indirect calorimetry (ventilated hood) for 6 hours after a breakfast meal | Week 1, week 5, week 6, week 10. | 
| Body Volume | Measured with Air Displacement plethysmography (BODPOD), | Week 1, week 5, week 6, week 10. | 
| Bone Mineral Content | Measured with Dual energy x-ray absorptiometry (DEXA) | Week 1, week 5, week 6, week 10. | 
| Total Body Water | Measured with deuterium dilution | Week 1, week 5, week 6, week 10. | 
| Body Composition | 4 compartment model to assess changes in body composition (Combined from the measures of body weight, body volume, total body water and bone mineral) | Week 1, week 5, week 6, week 10. | 
| Gastric emptying | Gastric emptying measured using stable isotope, Octanoic acid labelled breath samples. | Week 1, week 5, week 6, week 10. | 
| Waist and hip circumference | Change in waist and hip circumferences and waist to hip ratio | Week 1, week 5, week 6, week 10. | 
| Gut appetite hormones | Change in plasma fasting and 2 hr post-meal appetite hormones | Week 1, week 5, week 6, week 10. | 
| Plasma glucose | Change in plasma fasting and 2 hr post-meal glucose | Week 1, week 5, week 6, week 10. | 
| Plasma insulin | Change in plasma fasting and 2 hr post-meal insulin | Week 1, week 5, week 6, week 10. | 
| Blood lipids | Change in plasma fasting and 2 hr post-meal blood lipids | Week 1, week 5, week 6, week 10. | 
| Daily Subjective Appetite | Changes in subjective appetite (hunger, fullness, desire to eat) measured using visual analogue scale questionnaires every waking hour for 3 days. | Hourly measures for 3 days in week 1,week 5, week 6, week 10. | 
| Postprandial Subjective Appetite | Changes in subjective appetite (hunger, fullness, desire to eat) measured using visual analogue scale questionnaires every 30 minutes for 6 hours after test meals. | Week 1, week 5, week 6, week 10. | 
| Faecal sample analysis for gut health | Chronic influence on changes in gut microbiota | Week 1, week 5, week 6, week 10. | 
| Physical activity | Change in physical activity levels measured with accelerometer (actigraph) | Measured continuously for 24 hours for 3 days in week 1,week 5, week 6, week 10. | 
| 24 hour blood glucose | Changes in 24 hour blood glucose levels measured with a continuous glucose monitor | Measured continuously for 24 hours for 3 days in week 1,week 5, week 6, week 10. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Weight loss, Chrono-nutrition, Diet, energy expenditure