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Early vs Late Dinner for Obesity (DTOP 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

For the Obesity-Prediabetes (OPD) cohort: Male and female adults, age 18-50, with BMI ≥30 kg/m2 and prediabetes

For the Normal-Weight Healthy (NWH) cohort: Healthy male and female adults, age 18-50, with BMI 18-24.9 kg/m2 inclusively

Must not have

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

Gastrointestinal disorders that can lead to obstruction of the digestive tract (i.e. diverticular disease, history of bowel obstruction, inflammatory bowel disease, motility disorder)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 4 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will study how the timing of our food intake in relation to our body's internal clock affects our weight and metabolism.

Who is the study for?

Adults aged 18-50 with obesity and prediabetes (BMI ≥30 kg/m2) or healthy subjects with a BMI of 18-24.9 can join this study. Participants must understand the procedures, not have metabolic disorders, gastrointestinal surgeries, severe sleep issues, or be on certain medications that affect metabolism.

What is being tested?

The trial is testing how eating dinner early versus late affects weight and metabolism in relation to our body's natural clock. It uses precise methods to measure the body's circadian rhythm and its impact on health when aligning meal times.

What are the potential side effects?

There may be minimal side effects as this study primarily involves changing dinner times rather than medication intake; however, discomfort from adhering to new eating schedules could occur.

Eligibility Criteria

Inclusion Criteria

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

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I am 18-50 years old, overweight, and have prediabetes.

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I am a healthy adult aged 18-50 with a BMI between 18-24.9.

Exclusion Criteria

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

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I am taking medication that can affect my body's daily rhythms.

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I have a condition that could block my digestive system.

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

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I have diabetes or take diabetes medication other than metformin.

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I have a history of an inherited metabolic disorder.

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I have difficulty swallowing.

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I have had surgery on my digestive system.

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I have kidney disease.

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I am in or past menopause, confirmed by hormone levels or irregular periods.

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I have lost or gained more than 5% of my body weight in the last 3 months.

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I have had weight loss surgery in the past.

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My weight is either below 40 kg or above 180 kg.

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I have a sleep disorder like insomnia or sleep apnea that's not treated.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 4 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

24-hour total fat oxidation

Secondary study objectives

14-hour post-dinner cumulative dietary fat oxidation

4-hour post-prandial area-under-the-curve (AUC) glucose levels

4-hour post-prandial area-under-the-curve insulin levels

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Late Dinner FirstExperimental Treatment4 Interventions

Participants will be served dinner and a stable isotope of oral \[2H31\] palmitate to measure fat oxidation, at a late dinner time (after DLMO). This arm will then cross-over to Early Dinner as the second metabolic visit.

Group II: Early Dinner FirstExperimental Treatment4 Interventions

Participants will be served dinner and a stable isotope of oral \[2H31\] palmitate to measure fat oxidation, at an early dinner time (before DLMO). This arm will then cross-over to Late Dinner as the second metabolic visit.

0 / 15Eligibility criteria met