Effect of Dietary Patterns on Energy Balance Control and Circadian Rhythms

Study Overview
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Brief Summary
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The goal of this clinical trial is to to test the effects of dietary composition, on the rhythms of food intake and appetite regulation, and rhythms of energy expenditure. Participants will: complete 2 field-based dietary interventions be provided with standard meals record daily food intakes in a real-time manner complete 2 inpatient stays be provided with standard meals have frequent blood draws provide urine, saliva, stool and rectal swab samples

Detailed Description
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Obesity is an ongoing epidemic and a serious public health problem. Recent insights into the involvement of the circadian system (i.e., an internal biological rhythm) in energy expenditure and appetite control offer a new perspective to understand the relationship between dietary composition and weight management. Particularly, dietary composition may impact whole-body physiology in part through changes in the circadian system. The study protocol is designed to test the effects of dietary composition, on the rhythms of food intake and appetite regulation, and rhythms of energy expenditure. This study seeks to understand the relationship between dietary composition and weight control in order to lay the groundwork for evidence-based dietary intervention to combat obesity.

Official Title
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Effect of Dietary Patterns on Energy Balance Control and Circadian Rhythms

Conditions
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Dietary Habits

Intervention / Treatment
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* Behavioral: dietary intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-45 yr old BMI 18.5-29.9 No acute, chronic or debilitating medical conditions (e.g. metabolic, cardiovascular, respiratory, neurological, cancers, etc.) Exclusion Criteria: Currently smoking/vaping or 5 or more years of smoking/vaping History of drug or alcohol dependency History of psychiatric illness or disorder

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dietary A-B Intervention<br>The Dietary A first, then the Dietary B intervention. Since this is a single blind study, the details of the dietary interventions cannot be released during recruitment stage but will be made public once enrollment closes. | Behavioral: dietary intervention<br>* Research participants will be assigned to two dietary conditions.<br>|
| Experimental: Dietary B-A Intervention<br>The Dietary B first, then the Dietary A intervention. Since this is a single blind study, the details of the dietary interventions cannot be released during recruitment stage but will be made public once enrollment closes. | Behavioral: dietary intervention<br>* Research participants will be assigned to two dietary conditions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Circadian phase of melatonin rhythm | Hourly plasma melatonin will be measured under the Constant Routine condition | Days 18-19 | 
| Percentage of daily caloric intake in the biological evening | Percentage of caloric intake within the 4 hours before bedtime will be derived from real-time record of food and beverage intake during the intervention period | Days 7-14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Circadian amplitude of melatonin rhythm | Hourly circulating melatonin will be measured under the Constant Routine condition | Days 18-19 | 
| Circadian amplitude of subjective hunger rhythms | Hourly subjective hunger will be measured by Visual Analog under the Constant Routine condition | Days 18-19 | 
| Circadian phase of resting energy expenditure | Hourly energy expenditure will be measured by indirect calorimetry under the Constant Routine condition | Days 18-19 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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circadian rhythm, energy expenditure, appetite regulation