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Meal timing for Improving Cardiometabolic Outcomes in Older Adults(PPG6 Trial)

Northwestern University, Chicago, IL
Meal timing +3 moreN/ARecruitingLed by Phyllis Zee, MD, PhDResearch Sponsored by Northwestern University

PPG6 Trial Summary

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

PPG6 Trial Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
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You should sleep for at least 6.5 hours or more each night.
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You tend to sleep regularly between 1 am and 5 am.
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You typically sleep less than 9 hours per night.

PPG6 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Matsuda Index
Melatonin Amplitude
Nocturnal Blood Pressure Dipping

PPG6 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
~2300

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,548 Previous Clinical Trials
909,663 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the capacity of enrollees for this clinical research?

"Affirmative. Clinicaltrials.gov verifies that this medical trial, first posted on March 1st 2018 and most recently updated November 15th 2022, is actively recruiting patients with a goal of 100 enrollees at one location."

Answered by AI

Is the age limit of this clinical trial restricted to those over sixty years old?

"Participants in this trial must be aged between 55 and 75 years."

Answered by AI

Does this experiment have any restrictions on who can join?

"This research requires 100 eligible senior citizens aged 55 to 75 with improved cardiometabolic health. A few of the necessary qualifications include post-menopausal women, BMI between 25 and 45, a typical mid-sleep time from 1am to 5am, regular eating schedule (at least two meals daily), sleep duration of at least 6.5 hours per day, no more than nine hours in bed each night, and an average overnight fast not exceeding 13 hours across three days' worth of food intake tracking."

Answered by AI

Does this research currently have open enrollment?

"As per the clinicaltrials.gov, this research initiative is accepting participants now. The trial was initially published on March 1st 2018 and was recently revised on November 15th 2022."

Answered by AI
~15 spots leftby Nov 2024