Eating to Adjust the Timing System (EATS)

Mass General Brigham

Status: Enrolling

Conditions: Dietary Intervention

Treatments: Behavioral: dietary intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05800990

2023P000622

Details and patient eligibility

About

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

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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24 participants in 2 patient groups

Dietary A-B Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: dietary intervention

Dietary B-A Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: dietary intervention