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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 CriteriaYou will be eligible if you check “Yes” for the criteria below
PPG6 Trial Timeline
Study ObjectivesOutcome measures can provide a clearer picture of what you can expect from a treatment.
PPG6 Trial Design
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Who is running the clinical trial?
- Your mini mental status exam score is lower than 26, which means you may have trouble with your memory and thinking.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 are currently taking or have taken melatonin in the past month.You are currently taking hormone replacement therapy.You drink more than 4 cups of coffee or other caffeinated beverages every day.You have severe or unstable health problems.You have vision problems that cannot be corrected with glasses.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 regularly smoking at least 6 cigarettes per week.You have a history of brain or thinking problems.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.
- Group 1: Meal timing + Melatonin
- Group 2: Meal timing + Placebo
- Group 3: Placebo
- Group 4: Melatonin
- 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.
Frequently Asked Questions
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."
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."
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."
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."
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