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Aging Program Project Grant 6 (PPG6 Trial)

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 older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks

Summary

This trial will study the effects of meal timing and melatonin supplements on cardiometabolic function in older adults.

Who is the study for?
This trial is for older adults aged 55-75 with a BMI of 25-45. Participants should be post-menopausal women or men, not diabetic, and have regular eating and sleeping patterns. They must not have cognitive impairment, depression, unstable medical conditions, or use certain medications including melatonin recently.
What is being tested?
The study tests if meal timing combined with melatonin supplements can improve cardiometabolic functions in older adults. It compares the effects of meal timing alone, melatonin alone, both interventions together, and placebos over short-term and extended periods.
What are the potential side effects?
Potential side effects may include changes in sleep patterns due to melatonin or digestive discomfort from new meal timings. However, specific side effects will depend on individual responses to the interventions.

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 EOF 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/Starch) 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 EOF will be imposed. This arm will also include a melatonin placebo (Lactose/Starch) 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
1,649 Previous Clinical Trials
958,671 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: NCT03490825 — N/A
Improving Cardiometabolic Outcomes in Older Adults Research Study Groups: Meal timing + Melatonin, Meal timing + Placebo, Placebo, Melatonin
Improving Cardiometabolic Outcomes in Older Adults Clinical Trial 2023: Meal Timing Highlights & Side Effects. Trial Name: NCT03490825 — N/A
Meal Timing 2023 Treatment Timeline for Medical Study. Trial Name: NCT03490825 — N/A
~13 spots leftby Dec 2025