Eating to Adjust the Timing System

NCT05800990 | Recruiting

• 1 other identifier: 2023P000622
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Keywords

circadian rhythm; energy expenditure; appetite regulation

Outcome Measures

Primary Outcomes (2)

• Circadian phase of melatonin rhythm

  Hourly plasma melatonin will be measured under the Constant Routine condition

  Days 18-19

• 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

  Days 8-14

Secondary Outcomes (3)

• Circadian amplitude of melatonin rhythm

  Days 18-19

• Circadian amplitude of subjective hunger rhythms

  Days 18-19

• Circadian phase of resting energy expenditure

  Days 18-19

Other Outcomes (13)

• Diurnal variations of postprandial ghrelin responses

  Days 17

• Diurnal profile of leptin

  Days 17

• Diurnal profile of subjective hunger ratings

  Day 17

Study Arms (2)

Dietary A-B Intervention

EXPERIMENTAL

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.

Behavioral: dietary intervention

Dietary B-A Intervention

EXPERIMENTAL

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.

Behavioral: dietary intervention

Interventions

dietary intervention BEHAVIORAL

Research participants will be assigned to two dietary conditions.

Dietary A-B Intervention; Dietary B-A Intervention

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Interventions

Diet Therapy

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Frank AJL Scheer, PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frank A.J.L. Scheer, PhD

CONTACT

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

Jingyi Qian, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: April 6, 2023
• Study Start: November 8, 2024
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)