Effect of Dietary Patterns on Energy Balance Control and Circadian Rhythms
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Dietary A-B Intervention 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
Research participants will be assigned to two dietary conditions.
|
| Experimental: Dietary B-A Intervention 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
Research participants will be assigned to two dietary conditions.
|
Outcome Measures
Primary Outcome Measures
- Circadian phase of melatonin rhythm [Days 18-19]
Hourly plasma melatonin will be measured under the Constant Routine condition
- Percentage of daily caloric intake in the biological evening [Days 7-14]
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
Secondary Outcome Measures
- Circadian amplitude of melatonin rhythm [Days 18-19]
Hourly circulating melatonin will be measured under the Constant Routine condition
- Circadian amplitude of subjective hunger rhythms [Days 18-19]
Hourly subjective hunger will be measured by Visual Analog under the Constant Routine condition
- Circadian phase of resting energy expenditure [Days 18-19]
Hourly energy expenditure will be measured by indirect calorimetry under the Constant Routine condition
Other Outcome Measures
- Diurnal variations of postprandial ghrelin responses [Days 17]
Postprandial circulating ghrelin will be measured at test meals on Test Day
- Diurnal profile of leptin [Days 17]
Circulating leptin will be measured hourly on Test Day
- Diurnal profile of subjective hunger ratings [Day 17]
Hourly subjective hunger will be measured by Visual Analog on Test Day
- Circadian amplitude of resting energy expenditure [Days 18-19]
Hourly resting energy expenditure will be measured by indirect calorimetry under the Constant Routine condition
- Diurnal profile of resting energy expenditure [Day 17]
Resting energy expenditure will be measured at 1-2 hours interval by indirect calorimetry on Test Day
- Diurnal profile of respiratory exchange ratio [Day 17]
Respiratory exchange ratio will be measured at 1-2 hours interval by indirect calorimetry on Test Day
- Circadian amplitude and phase of respiratory exchange ratio [Days 18-19]
Hourly respiratory exchange ratio will be measured by indirect calorimetry under the Constant Routine condition
- Circadian phase and amplitude of glucose rhythm [Days 18-19]
Hourly circulating glucose will be measured under the Constant Routine condition
- Circadian phase and amplitude of insulin rhythm [Days 18-19]
Hourly circulating insulin will be measured under the Constant Routine condition
- Circadian phase and amplitude of cortisol rhythm [Days 18-19]
Hourly circulating cortisol will be measured under the Constant Routine condition
- Circadian phase and amplitude of core body temperature rhythm [Days 18-19]
Core body temperature will be measured continuously under the Constant Routine condition
- Diurnal profile of lipids [Day 17]
Hourly circulating lipids will be measured on Test Day
- Circadian phase and amplitude of lipids [Days 18-19]
Hourly circulating lipids will be measured under Constant Routine condition
Eligibility Criteria
Criteria
Inclusion Criteria:
-
18-45 yr old
-
BMI 18.5-29.9
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Brigham and Women's Hospital | Boston | Massachusetts | United States | 02115 |
Sponsors and Collaborators
- Brigham and Women's Hospital
- National Heart, Lung, and Blood Institute (NHLBI)
Investigators
- Principal Investigator: Frank AJL Scheer, PhD, Brigham and Women's Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022A006894