Clinical trial NCT05800990: Eating to Adjust the Timing System
Official title: Do Dietary Patterns Influence Your Weight Management and Circadian Rhythms?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dietary Intervention
Keywords: circadian rhythm
energy expenditure
appetite regulation
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2023-04-06
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Circadian phase of melatonin rhythm
timeFrame: Days 18-19
measure: Percentage of daily caloric intake in the biological evening
timeFrame: Days 8-14
Secondary outcomes:
measure: Circadian amplitude of melatonin rhythm
timeFrame: Days 18-19
measure: Circadian amplitude of subjective hunger rhythms
timeFrame: Days 18-19
measure: Circadian phase of resting energy expenditure
timeFrame: Days 18-19
Other outcomes:
measure: Diurnal variations of postprandial ghrelin responses
timeFrame: Days 17
measure: Diurnal profile of leptin
timeFrame: Days 17
measure: Diurnal profile of subjective hunger ratings
timeFrame: Day 17
measure: Circadian amplitude of resting energy expenditure
timeFrame: Days 18-19
measure: Diurnal profile of resting energy expenditure
timeFrame: Day 17
measure: Diurnal profile of respiratory exchange ratio
timeFrame: Day 17
measure: Circadian amplitude and phase of respiratory exchange ratio
timeFrame: Days 18-19
measure: Circadian phase and amplitude of glucose rhythm
timeFrame: Days 18-19
measure: Circadian phase and amplitude of insulin rhythm
timeFrame: Days 18-19
measure: Circadian phase and amplitude of cortisol rhythm
timeFrame: Days 18-19
measure: Circadian phase and amplitude of core body temperature rhythm
timeFrame: Days 18-19
measure: Diurnal profile of lipids
timeFrame: Day 17
measure: Circadian phase and amplitude of lipids
timeFrame: Days 18-19
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Frank AJL Scheer, PhD
role: PRINCIPAL_INVESTIGATOR
References: