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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

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

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

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