Can Food Timing Reduce Your Diabetes Risk?

Mass General Brigham

Status: Enrolling

Conditions: Dietary Habits

Treatments: Behavioral: Night shift protocol - Diet order B-A; Behavioral: Day shift protocol - Diet order B-A; Behavioral: Night shift protocol - Diet order A-B; Behavioral: Day shift protocol - Diet order A-B

Study type: Interventional

Funder types: Other

Identifiers

NCT05862818

2023P001063

Details and patient eligibility

About

The goal of this clinical trial is to test whether food timing impacts metabolic health in healthy participants.

Participants will:

• complete 2 inpatient stays
• be provided with test meals
• have frequent blood draws

Full description

The investigators aim to investigate the influence of different food timing, without changing 24-h caloric and nutrient intake, on glucose and fat tolerance and energy expenditure in healthy people on a simulated day or night shift.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy with no acute or chronic medical and psychiatric disorders
• BMI: 18.5-29.9 kg/m2

Exclusion criteria

• Smokers, current tobacco or e-cigarette use
• Drug or alcohol dependency
• Pregnant

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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48 participants in 4 patient groups

Day shift protocol with diet A

Experimental group

Description:

Day shift protocol with diet A condition. Since this is a single-blind study, the details of the meal conditions cannot be released during the recruitment stage but will be made public once enrollment closes.

Treatment:

Behavioral: Day shift protocol - Diet order A-B

Behavioral: Day shift protocol - Diet order B-A

Day shift protocol with diet B

Experimental group

Description:

Day shift protocol with diet B condition. Since this is a single-blind study, the details of the meal conditions cannot be released during the recruitment stage but will be made public once enrollment closes.

Treatment:

Behavioral: Day shift protocol - Diet order A-B

Behavioral: Day shift protocol - Diet order B-A

Night shift protocol with diet A

Experimental group

Description:

Night shift protocol with diet A condition. Since this is a single-blind study, the details of the meal conditions cannot be released during the recruitment stage but will be made public once enrollment closes.

Treatment:

Behavioral: Night shift protocol - Diet order A-B

Behavioral: Night shift protocol - Diet order B-A

Night shift protocol with diet B

Experimental group

Description:

Night shift protocol with diet B condition. Since this is a single-blind study, the details of the meal conditions cannot be released during the recruitment stage but will be made public once enrollment closes.

Treatment:

Behavioral: Night shift protocol - Diet order A-B

Behavioral: Night shift protocol - Diet order B-A