Eating to Adjust the Timing System

NCT ID: NCT05800990

Last Updated: 2025-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-08

Study Completion Date

2027-08-31

Brief Summary

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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

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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.

Conditions

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Dietary Intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

dietary intervention

Intervention Type BEHAVIORAL

Research participants will be assigned to two dietary conditions.

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.

Group Type EXPERIMENTAL

dietary intervention

Intervention Type BEHAVIORAL

Research participants will be assigned to two dietary conditions.

Interventions

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dietary intervention

Research participants will be assigned to two dietary conditions.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Frank AJL Scheer, PhD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Frank AJL Scheer, PhD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Frank A.J.L. Scheer, PhD

Role: CONTACT

617-732-7014

Jingyi Qian, PhD

Role: CONTACT

617-525-7423

Facility Contacts

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Arman Arab, PhD

Role: primary

617-278-0703

Rahul Reddy, Bsc

Role: backup

617-525-8259

Other Identifiers

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2023P000622

Identifier Type: -

Identifier Source: org_study_id

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