Aging Program Project Grant 6

NCT ID: NCT03490825

Last Updated: 2025-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2024-05-31

Brief 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.

Conditions

Improving Cardiometabolic Outcomes in Older Adults

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Melatonin 1 mg

Intervention Type: DIETARY_SUPPLEMENT

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.

Meal timing

Intervention Type: OTHER

Subjects are instructed to maintain an extended overnight fasting period of 12-16 hours.

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.

Group Type: EXPERIMENTAL

Placebos

Intervention Type: DIETARY_SUPPLEMENT

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.

Meal timing

Intervention Type: OTHER

Subjects are instructed to maintain an extended overnight fasting period of 12-16 hours.

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.

Group Type: EXPERIMENTAL

Melatonin 1 mg

Intervention Type: DIETARY_SUPPLEMENT

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.

Non-Meal timing

Intervention Type: OTHER

Subjects are instructed to maintain their habitual meal timing.

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.

Group Type: PLACEBO_COMPARATOR

Placebos

Intervention Type: DIETARY_SUPPLEMENT

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.

Non-Meal timing

Intervention Type: OTHER

Subjects are instructed to maintain their habitual meal timing.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

Meal timing

Subjects are instructed to maintain an extended overnight fasting period of 12-16 hours.

Intervention Type: OTHER

Non-Meal timing

Subjects are instructed to maintain their habitual meal timing.

Intervention Type: OTHER

Other Intervention Names

Extended overnight fasting (EOF); Non-extended overnight fasting (nEOF)

Eligibility Criteria

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.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Phyllis Zee

Professor of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Phyllis Zee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern University

Chicago, Illinois, United States

Countries

United States

Other Identifiers

STU00206014

Identifier Type: -

Identifier Source: org_study_id