Aging Program Project Grant 6
(PPG6 Trial)

Recruiting in Palo Alto (17 mi)

Overseen ByPhyllis Zee, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Northwestern University

Trial Summary

What is the purpose of this trial?This study aims to enhance circadian signals to improve cardiometabolic functions in older adults though meal timing interventions and melatonin supplements. Cardiometabolic disease (CMD) is prevalent among older adults, but despite vigorous research to prevent it, it remains on of the greatest public health challenges. Previous research has shown that extended overnight fasting and melatonin supplements may enhance circadian signals which in turn would enhance cardiometabolic function in older adults. This study will place subjects in one of four intervention groups, 1) Meal timing + Melatonin, 2) Meal timing + Placebo, 3) Melatonin, or 4) Placebo in order test out the effects of meal timing and melatonin both separately and together and cardio metabolic functions. The study will explore the effects of these interventions in acute-based setting and extended-based settings. This will allow us to test out the hypotheses of the study that meal timing can improve amplitude of circadian signals and improve cardiometabolic functions and sleep quality as well as melatonin improving cardiometabolic function and sleep quality. Finally, we will determine if the the addition of melatonin will further enhance the effects of the meal timing intervention for improving cardiometabolic function and sleep.

Eligibility Criteria

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.

Inclusion Criteria

Older adults 55-75 years old

BMI 25-45

Females must be post-menopausal

+6 more

Exclusion Criteria

Your mini mental status exam score is lower than 26, which means you may have trouble with your memory and thinking.

Individuals with pacemakers, defibrillators, mediation pumps, or any other implanted device

Shift work or other self-imposed irregular sleep schedules

+23 more

Participant Groups

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.

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.