Eating to Adjust the Timing System
ConditionDietary Intervention
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorBrigham and Women's Hospital
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
dietary intervention
BehavioralResearch participants will be assigned to two dietary conditions.
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: Dietary A-B InterventionExperimental treatment 1 intervention
Group B: Dietary B-A InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Circadian phase of melatonin rhythm
Hourly plasma melatonin will be measured under the Constant Routine condition
Time frame
Days 18-192
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
Time frame
Days 8-14Secondary outcomes
1
Circadian amplitude of melatonin rhythm
Hourly circulating melatonin will be measured under the Constant Routine condition
Time frame
Days 18-192
Circadian amplitude of subjective hunger rhythms
Hourly subjective hunger will be measured by Visual Analog Scale under the Constant Routine condition
Time frame
Days 18-193
Circadian phase of resting energy expenditure
Every other hour energy expenditure will be measured by indirect calorimetry under the Constant Routine condition
Time frame
Days 18-19Other outcomes
1
Diurnal variations of postprandial ghrelin responses
Postprandial circulating ghrelin will be measured at test meals on Test Day
Time frame
Days 172
Diurnal profile of leptin
Circulating leptin will be measured hourly on Test Day
Time frame
Days 173
Diurnal profile of subjective hunger ratings
Hourly subjective hunger will be measured by Visual Analog Scale on Test Day
Time frame
Day 174
Circadian amplitude of resting energy expenditure
Every other hour resting energy expenditure will be measured by indirect calorimetry under the Constant Routine condition
Time frame
Days 18-19Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Brigham and Women's Hospital
Lead sponsor
National Institutes of Health (NIH)
Collaborator
Source ClinicalTrials.gov