Dietary Intervention to Mitigate Adverse Consequences of Night Work

Mass General Brigham

Status: Enrolling

Conditions: Dietary Habits

Treatments: Behavioral: dietary intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04868526

R01HL153969 (U.S. NIH Grant/Contract)

2021P000683

Details and patient eligibility

About

The goal of this clinical trial is to test whether our dietary intervention can prevent or lessen the negative health effects of night shift work in healthy participants.

Participants will:

• complete 2 inpatient stays
• be provided with identical meals
• have frequent blood draws
• provide urine, saliva, stool and rectal swab samples

Full description

Shift work increases the risk for diabetes possibly due to the adverse metabolic effects of circadian misalignment. As shift work is not foreseen to disappear, the development of individually-targeted therapies for metabolic health in these vulnerable shift workers is urgently needed. This research will determine whether our dietary intervention can mitigate the adverse metabolic effects of circadian misalignment, which may help in the design of evidence-based dietary interventions to improve the metabolic health in shift workers.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18-45 yr old
• BMI 20.0-29.9
• European/Hispanic/African-American ancestry
• No acute, chronic or debilitating medical conditions (e.g. metabolic, cardiovascular, respiratory, neurological, cancers, etc.)

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

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

Control-Dietary Intervention

Experimental group

Description:

Control condition first, then the Dietary 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 intervention-Control

Experimental group

Description:

Dietary intervention first, then the Control condition. 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