Eating to Adjust the Timing System
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: dietary intervention.
- Who it may be relevant to
- Registry conditions: Dietary Intervention. Basic parameters: 18 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Do Dietary Patterns Influence Your Weight Management and Circadian Rhythms?
Overview
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
- Behavioral dietary intervention
Research participants will be assigned to two dietary conditions.
Primary outcome measures
- Circadian phase of melatonin rhythm [Time frame: Days 18-19]
- Percentage of daily caloric intake in the biological evening [Time frame: Days 8-14]
Secondary outcome measures (3)
- Circadian amplitude of melatonin rhythm [Time frame: Days 18-19]
- Circadian amplitude of subjective hunger rhythms [Time frame: Days 18-19]
- Circadian phase of resting energy expenditure [Time frame: Days 18-19]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Brigham and Women's Hospital — Boston
Identifiers
NCT: NCT05800990 · 2023P000622