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Strengthening Circadian Signals for Improving Cardiometabolic Outcomes in Adults

N/A
Recruiting
Led By Phyllis Zee, MD, PhD
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

Summary

This trial will study the effects of meal timing and melatonin administration on cardiometabolic function in overweight and obese adults.

Who is the study for?
Adults aged 35-54 with a BMI of 25 to less than 45, regular sleep and eating schedules, an overnight fast of no more than 13 hours, and not suffering from severe medical conditions or taking certain medications. Excludes pregnant women, prisoners, those on recent weight loss programs or with sleep disorders.
What is being tested?
The trial is testing if meal timing and/or low-dose melatonin (1 mg) can improve cardiometabolic function by strengthening circadian rhythms in overweight adults. It's a placebo-controlled study with four different intervention groups over six weeks.
What are the potential side effects?
Potential side effects are not explicitly listed but may include typical reactions to melatonin such as drowsiness or changes in sleep patterns. Meal timing interventions generally have minimal side effects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 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
Matsuda Index
Melatonin Amplitude
Nocturnal Blood Pressure Dipping

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: MelatoninExperimental Treatment2 Interventions
This arm will continue to eat at their habitual meal times, and maintain their average habitual caloric and macronutrient intake. No extended overnight fasting will be imposed. This arm will include a 1mg melatonin supplementation given daily during the intervention.
Group II: Meal timing + PlaceboExperimental Treatment2 Interventions
This arm will consist of imposing a minimum overnight fasting period of 12 hours and a maximum of 16 hours (with exception of water and other non-caloric beverages), beginning 3 hours before their habitual bed time. This arm will also include a melatonin placebo (lactose) supplementation given daily during the intervention.
Group III: Meal timing + MelatoninExperimental Treatment2 Interventions
This arm will consist of imposing a minimum overnight fasting period of 12 hours and a maximum of 16 hours (with exception of water and other non-caloric beverages), beginning 3 hours before their habitual bed time. This arm will also include a 1mg melatonin supplementation given daily during the intervention.
Group IV: PlaceboPlacebo Group2 Interventions
This arm will continue to eat at their habitual meal times, and maintain their average habitual caloric and macronutrient intake. No extended overnight fasting will be imposed. This arm will also include a melatonin placebo (lactose) supplementation given daily during the intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebos
2019
Completed Phase 4
~2030

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,625 Previous Clinical Trials
937,189 Total Patients Enrolled
Phyllis Zee, MD, PhDPrincipal Investigator - Northwestern University
Northwestern Memorial Hospital
Finch U Of Hs/Chicago Medical Sch (Medical School)
Mc Gaw Mc/Northwestern University (Residency)
1 Previous Clinical Trials
100 Total Patients Enrolled

Media Library

Meal Timing Clinical Trial Eligibility Overview. Trial Name: NCT03490864 — N/A
Improving Cardiometabolic Outcomes in Adults Research Study Groups: Meal timing + Placebo, Meal timing + Melatonin, Melatonin, Placebo
Improving Cardiometabolic Outcomes in Adults Clinical Trial 2023: Meal Timing Highlights & Side Effects. Trial Name: NCT03490864 — N/A
Meal Timing 2023 Treatment Timeline for Medical Study. Trial Name: NCT03490864 — N/A
~14 spots leftby Sep 2025
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