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Recruiting NCT04868526

Dietary Intervention to Mitigate Adverse Consequences of Night Work

No phase Interventional Dietary Habits

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: dietary intervention.
Who it may be relevant to
Registry conditions: Dietary Habits. Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Detailed 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.

Interventions

  • Behavioral dietary intervention
    Research participants will be assigned to two dietary conditions.

Primary outcome measures

  • Change in glucose tolerance from Baseline to Test Day [Time frame: Baseline (Day 2) and Test Day (Day 4)]
  • Changes in microbial community structure/composition/function of oral and gut microbiome from Baseline to Test Day [Time frame: Baseline (Day 2) and Test Day (Day 4)]
Secondary outcome measures (4)
  • Change in insulin sensitivity (Oral Minimal Model method) from Baseline to Test Day [Time frame: Baseline (Day 2) and Test Day (Day 4)]
  • Change in levels of serum markers of gut microbiota from Baseline to Test Day [Time frame: Baseline (Day 2) and Test Day (Day 4)]
  • Change in levels of serum markers of intestinal barrier integrity from Baseline to Test Day [Time frame: Baseline (Day 2) and Test Day (Day 4)]
  • Change in level of serum markers of inflammatory state from Baseline to Test Day [Time frame: Baseline (Day 2) and Test Day (Day 4)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Basic science

Study locations

United States · 1 center
  • Brigham and Women's Hospital — Boston

Identifiers

NCT: NCT04868526 · 2021P000683 · R01HL153969

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗