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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 55 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
The study is designed as a randomized controlled trial where each participant will receive one of four intervention types. Subjects will be randomized at baseline visit to one of four arms using a randomized block design to achieve balanced groups. Randomization will be stratified by sex. The allocation will be created using an online randomization tool. This study will include a 6 week four arm field intervention to evaluate the independent effect of meal timing or melatonin as well as their combined effects
Primary Purpose
Basic Science
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Meal timing + Melatonin 		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.
  • Dietary Supplement: Melatonin 1 mg
    Melatonin (1mg) will be administered daily during the intervention. Melatonin capsules will be obtained from Life Extension (Ft. Lauderdale, FL). The investigational drug pharmacy (IDP) at Northwestern Memorial Hospital will encapsulate the melatonin pills so the placebo (lactose) and melatonin pills appear identical. We have worked with this IDP on other projects. The investigators on this study have experience in administering melatonin for investigational and clinical purposes.
  • Other: Meal timing
    Subjects are instructed to maintain an extended overnight fasting period of 12-16 hours.
    Other names:
    • Extended overnight fasting (EOF)
Experimental
Meal timing + Placebo 		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.
  • Dietary Supplement: Placebos
    Placebo will be administered daily during the intervention. The investigational drug pharmacy (IDP) at Northwestern Memorial Hospital will encapsulate the pills so the placebo (lactose/starch) and melatonin pills appear identical. We have worked with this IDP on other projects. The investigators on this study have experience in administering melatonin for investigational and clinical purposes.
  • Other: Meal timing
    Subjects are instructed to maintain an extended overnight fasting period of 12-16 hours.
    Other names:
    • Extended overnight fasting (EOF)
Experimental
Melatonin 		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.
  • Dietary Supplement: Melatonin 1 mg
    Melatonin (1mg) will be administered daily during the intervention. Melatonin capsules will be obtained from Life Extension (Ft. Lauderdale, FL). The investigational drug pharmacy (IDP) at Northwestern Memorial Hospital will encapsulate the melatonin pills so the placebo (lactose) and melatonin pills appear identical. We have worked with this IDP on other projects. The investigators on this study have experience in administering melatonin for investigational and clinical purposes.
  • Other: Non-Meal timing
    Subjects are instructed to maintain their habitual meal timing.
    Other names:
    • Non-extended overnight fasting (nEOF)
Placebo Comparator
Placebo 		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.
  • Dietary Supplement: Placebos
    Placebo will be administered daily during the intervention. The investigational drug pharmacy (IDP) at Northwestern Memorial Hospital will encapsulate the pills so the placebo (lactose/starch) and melatonin pills appear identical. We have worked with this IDP on other projects. The investigators on this study have experience in administering melatonin for investigational and clinical purposes.
  • Other: Non-Meal timing
    Subjects are instructed to maintain their habitual meal timing.
    Other names:
    • Non-extended overnight fasting (nEOF)

Recruiting Locations

Northwestern University
Chicago, Illinois 60611
Contact:
Kathyrn Reid, PhD
312-503-1528
k-reid@northwestern.edu

More Details

NCT ID
NCT03490825
Status
Recruiting
Sponsor
Northwestern University

Study Contact

Phyllis Zee, MD, PhD
312-503-4409
p-zee@northwestern.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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