Aging Program Project Grant 6 (PPG6)

  • STATUS
    Recruiting
  • days left to enroll
    63
  • participants needed
    100
  • sponsor
    Northwestern University
Updated on 18 April 2022
Accepts healthy volunteers

Summary

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.

Details
Condition Improving Cardiometabolic Outcomes in Older Adults
Treatment placebos, Melatonin 3 mg, Meal timing, Meal timing, Non-Meal timing, Melatonin 1 mg
Clinical Study IdentifierNCT03490825
SponsorNorthwestern University
Last Modified on18 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Older adults 55-75 years old
Females must be post-menopausal
BMI 25-45
Regular eating schedule (consuming at least 2 meals/day) and sleeping schedules (deviation of ≤ 2 hours in daily mid-sleep time)
Self-report sleep duration of ≥ 6.5 hours
Habitual mid-sleep time of 1-5 am
Habitual time in bed less than 9 hours
HbA1c <6.5
Habitual overnight fast of ≤ 13 hour (Determined by a mean overnight fast ≤ 13 hours over 3 days of self-monitoring of food intake)

Exclusion Criteria

History or current diagnosis of a primary sleep disorder (Chronic insomnia, restless leg syndrome, parasomnias, sleep apnea)
AHI ≥30
History of anemia
Diagnosis of diabetes or currently on any medications for diabetes
Endocrine dysfunction including PCOS
History of cognitive or other neurological disorders
History of DSM-V criteria for any major psychiatric disorder
Beck depression Index (BDI) of ≥16 indicating moderate depression
Mini mental status Exam <26 indicating cognitive impairment
Unstable or serious medical conditions
Individuals with pacemakers, defibrillators, mediation pumps, or any other implanted device
Any GI disease that requires dietary adjustment
Current or use within last month of melatonin
Current use of psychoactive, hypnotic, stimulants, or pain medications
Current use of hormone replacement therapy
Shift work or other self-imposed irregular sleep schedules
History of habitual smoking (≥6 cigarettes/week)
Caffeine consumption >400 mg/day
Medically managed or self-reported weight loss program within past 6 months
Bariatric weight loss surgery
Blindness or visual impairment other than glasses
Allergic to heparin
Adults unable to consent will be excluded
Pregnant women will be excluded
Prisoners will be excluded
Individuals who are not yet adults (infants, children, teenagers) will be excluded
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