Eating to Adjust the Timing System

Brigham and Women's Hospital24 enrolled

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

Conditions

Dietary Intervention

Interventions

dietary interventionBEHAVIORAL

Research participants will be assigned to two dietary conditions.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Brigham and Women's Hospital

Boston, Massachusetts, United States

RECRUITING

Outcomes

Primary Outcomes

Circadian phase of melatonin rhythm

Hourly plasma melatonin will be measured under the Constant Routine condition

Time frame: 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

Time frame: Days 8-14

Secondary Outcomes

Circadian amplitude of melatonin rhythm

Hourly circulating melatonin will be measured under the Constant Routine condition

Time frame: Days 18-19

Circadian amplitude of subjective hunger rhythms

Hourly subjective hunger will be measured by Visual Analog Scale under the Constant Routine condition

Time frame: Days 18-19

Circadian phase of resting energy expenditure

Every other hour energy expenditure will be measured by indirect calorimetry under the Constant Routine condition

Time frame: Days 18-19

Central 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

Data from ClinicalTrials.gov

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