Dietary Intervention
Conditions
Keywords
circadian rhythm, energy expenditure, appetite regulation
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.
Interventions
BEHAVIORALdietary intervention
Research participants will be assigned to two dietary conditions.
Sponsors
National Institutes of Health (NIH)
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.) * Without medication use (except oral contraceptives)
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 * People with food allergies/intolerances or following specific diets
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Diurnal profile of subjective hunger ratings | Day 17 | Hourly subjective hunger will be measured by Visual Analog Scale on Test Day |
| Circadian amplitude of resting energy expenditure | Days 18-19 | Every other hour resting energy expenditure will be measured by indirect calorimetry under the Constant Routine condition |
| Diurnal profile of resting energy expenditure | Day 17 | Indirect calorimetry will be done 30 minutes before each test meal and three 30-minute postprandial tests starting at 30, 90, and 240 min after each test meal on Test day by indirect calorimetry |
| Diurnal profile of respiratory exchange ratio | Day 17 | Respiratory exchange ratio will be measured 30 minutes before each test meal and three 30-minute postprandial tests starting at 30, 90, and 240 min after each test meal on Test Day by indirect calorimetry |
| Circadian phase and amplitude of core body temperature rhythm | Days 18-19 | Core body temperature will be measured continuously 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 amplitude and phase of respiratory exchange ratio | Days 18-19 | Every other hour respiratory exchange ratio will be measured by indirect calorimetry 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 |
| 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 |
Countries
United States
Contacts
Primary ContactFrank A.J.L. Scheer, PhD
Backup ContactJingyi Qian, PhD
Outcome results
None listed