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Recruiting NCT05862818

Can Food Timing Reduce Your Diabetes Risk?

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: Day shift protocol - Diet order A-B, Day shift protocol - Diet order B-A, Night shift protocol - Diet order A-B, Night shift protocol - Diet order B-A.
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 food timing impacts metabolic health in healthy participants. Participants will: * complete 2 inpatient stays * be provided with test meals * have frequent blood draws

Detailed 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.

Interventions

  • Behavioral Day shift protocol - Diet order A-B
    Research participants will be assigned to day shift condition and Diet A-B order condition.
  • Behavioral Day shift protocol - Diet order B-A
    Research participants will be assigned to day shift condition and Diet B-A order condition.
  • Behavioral Night shift protocol - Diet order A-B
    Research participants will be assigned to simulated night shift condition and Diet A-B order condition.
  • Behavioral Night shift protocol - Diet order B-A
    Research participants will be assigned to simulated night shift condition and Diet B-A order condition.

Primary outcome measures

  • Difference in glucose tolerance between Meal Conditions and Shift Work [Time frame: 24 hours]
  • Difference in diet-induced thermogenesis between Meal Conditions and Shift Work [Time frame: 24 hours]
  • Difference in plasma triglyceride level between Meal Conditions and Shift Work [Time frame: 24 hours]
Secondary outcome measures (6)
  • Difference in insulin sensitivity between Meal Conditions and Shift Work [Time frame: 24 hours]
  • Difference in beta-cell function between Meal Conditions and Shift Work [Time frame: 24 hours]
  • Difference in 24-h glycemia between Meal Conditions and Shift Work [Time frame: 24 hours]
  • Difference in postprandial incretin level between Meal Conditions and Shift Work [Time frame: 24 hours]
  • Difference in substrate oxidation between Meal Conditions and Shift Work [Time frame: 24 hours]
  • Difference in plasma free fatty acids level between Meal Conditions and Shift Work [Time frame: 24 hours]

Eligibility criteria

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

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: NCT05862818 · 2023P001063

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗