Eating to Adjust the Timing System
- Conditions
- Dietary Intervention
- Interventions
- Behavioral: dietary intervention
- Registration Number
- NCT05800990
- Lead Sponsor
- Brigham and Women's Hospital
- Brief Summary
The goal of this clinical trial is to test the effects of dietary composition on the rhythms of food intake, appetite regulation, and rhythms of energy expenditure.
Participants will:
complete 2 field-based dietary interventions be provided with standard meals record daily food intake in a real-time manner complete 2 inpatient stays be provided with standard meals have frequent blood draws provide urine, saliva, and stool samples
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 24
- 18-45 yr old
- BMI 18.5-29.9
- No acute, chronic or debilitating medical conditions (e.g. metabolic, cardiovascular, respiratory, neurological, cancers, etc.)
- Without medication use (except oral contraceptives)
- Currently smoking/vaping or 5 or more years of smoking/vaping
- History of drug or alcohol dependency
- History of psychiatric illness or disorder
- People with food allergies/intolerances or following specific diets
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Dietary A-B Intervention dietary 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. Dietary B-A Intervention dietary 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.
- Primary Outcome Measures
Name Time Method 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 8-14 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
Name Time Method 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 Scale under the Constant Routine condition
Circadian phase of resting energy expenditure Days 18-19 Every other hour energy expenditure will be measured by indirect calorimetry under the Constant Routine condition
Trial Locations
- Locations (1)
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States