Recruiting

Observational Study

Sponsor:

Brigham and Women's Hospital

Code:

NCT05800990

Conditions

Dietary Intervention

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

dietary intervention

Study Details

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

Conditions

Dietary Intervention

Study ID

NCT05800990

Start date

Nov 8, 2024

Status verified date

Sep, 2025

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

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

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Dietary A-B 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.

experimental: Dietary B-A 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.

Interventions

dietary intervention

Research participants will be assigned to two dietary conditions.

Primary outcome measure

  • Circadian phase of melatonin rhythm [ Time Frame: Days 18-19 ]
  • Percentage of daily caloric intake in the biological evening [ Time Frame: Days 8-14 ]

Central Contacts and Locations

Central contacts

Frank A.J.L. Scheer, PhD

617-732-7014FSCHEER@BWH.HARVARD.EDU

Jingyi Qian, PhD

617-525-7423jqian@bwh.harvard.edu

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Arman Arab, PhD

617-278-0703aarab1@mgb.org

Rahul Reddy, Bsc

617-525-8259rmreddy@bwh.harvard.edu

Principal Investigator:

Frank A.J.L. Scheer, PhD

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Sep 29, 2025

Last verified

Sep, 2025

Keywords

  • circadian rhythm
  • energy expenditure
  • appetite regulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2025-09-29.