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Meal timing for Improving Cardiometabolic Outcomes in Older Adults (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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
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
1,645 Previous Clinical Trials
958,494 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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Your mini mental status exam score is lower than 26, which means you may have trouble with your memory and thinking.You are currently taking or have taken melatonin in the past month.You drink more than 4 cups of coffee or other caffeinated beverages every day.You are currently taking hormone replacement therapy.You have severe or unstable health problems.You have vision problems that cannot be corrected with glasses.You have a history of regularly smoking at least 6 cigarettes per week.You have had weight loss surgery (bariatric surgery).You are allergic to heparin.You tend to sleep regularly between 1 am and 5 am.You typically sleep less than 9 hours per night.You have a history of brain or thinking problems.You have a hormone-related condition called PCOS (polycystic ovary syndrome) or other hormonal disorders.You are currently taking medications for mental health, sleep, energy, or pain relief.You have a gastrointestinal (GI) disease that needs special dietary changes.You have or had a sleep disorder like chronic insomnia, restless leg syndrome, sleep apnea, or other sleep-related conditions.You should sleep for at least 6.5 hours or more each night.You have a history of any major mental health disorder as defined by the DSM-V.
Research Study Groups:
This trial has the following groups:- Group 1: Meal timing + Melatonin
- Group 2: Meal timing + Placebo
- Group 3: Placebo
- Group 4: Melatonin
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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