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Meal Timing and Sleep for Metabolic Health in Healthy Subjects (DT2 Trial)

N/A

Recruiting

Led By Jonathan Jun, MD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Chronic use of sedative hypnotics, anxiolytics, opiates

Diabetes (type 1 or 2)

Must not have

Any known history of an inherited metabolic disorder

Use of medications that can affect circadian rhythm (beta blockers, melatonin)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 2 weeks prior to baseline (samples drawn every 30 minutes, up to 7 hours)

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at the effects of eating dinner at different times, based on an individual's natural sleep cycle. Blood samples will be taken to measure how well the body processes different nutrients.

Who is the study for?

This trial is for healthy adults aged 18-30, with a BMI of 18-30 kg/m2 and normal sleep patterns (bedtime before 1:00 A.M. and mid-sleep before 5 A.M.). Participants should not be smokers or have conditions like diabetes, sleep disorders, GERD that affects eating near bedtime, or use medications affecting circadian rhythms.

What is being tested?

The study investigates how the timing of dinner relative to one's own circadian rhythm impacts metabolism. It involves having an early or late dinner based on melatonin onset measurements and observing changes in metabolic markers like glucose and insulin levels.

What are the potential side effects?

Since this trial involves only meal timing adjustments without any drugs or medical interventions, there are no direct side effects expected from participating in the study itself.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I regularly use medications for anxiety, sleep, or pain.

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I have diabetes (type 1 or 2).

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of an inherited metabolic disorder.

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I am taking medications that could affect my sleep-wake cycle.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 2 weeks prior to baseline (samples drawn every 30 minutes, up to 7 hours)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 2 weeks prior to baseline (samples drawn every 30 minutes, up to 7 hours)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 2 weeks prior to baseline (samples drawn every 30 minutes, up to 7 hours) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Free Fatty Acids (FFA, mmol/L)

Change in Glucose (mg/dl)

Change in Insulin (mcU/ml)

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Late Dinner firstExperimental Treatment3 Interventions

Participants will be served dinner and a stable isotope of palmitate to measure fat oxidation, at a late dinner time (DLMO+1h) followed by a sleep study (DLMO+2h). This arm will cross-over to the other 2 arms in random order.

Group II: Late Dinner + Late Sleep firstExperimental Treatment3 Interventions

Participants will be served dinner and a stable isotope of palmitate to measure fat oxidation, at a late dinner time (DLMO+1h) followed by delayed bedtime (DLMO+6h). This arm will cross-over to the other 2 arms in random order.

Group III: Early Dinner firstExperimental Treatment3 Interventions

Participants will be served dinner and a stable isotope of palmitate to measure fat oxidation, at an early dinner time (DLMO-3h) followed by a sleep study (DLMO+2h). This arm will cross-over to the other 2 arms in random order.

0 / 4Eligibility criteria met