Aging Program Project Grant 6

NCT03490825 | Completed

• 1 other identifier: STU00206014
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Matsuda Index

  The matsuda index of whole body index sensitivity will be calculated to explore the effect of sleep and circadian rhythms on the relationship between EOF, melatonin, and CMD.

  8 weeks

• Nocturnal Blood Pressure Dipping

  Defined as a ratio of sleep blood pressure to wake blood pressure less than 0.90.

  8 weeks

• Melatonin Amplitude

  The melatonin amplitude will be calculated to determine the effects of the interventions on sleep and CMD outcomes.

  8 weeks

Study Arms (4)

Meal timing + Melatonin

EXPERIMENTAL

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; Other: Meal timing

Meal timing + Placebo

EXPERIMENTAL

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; Other: Meal timing

Melatonin

EXPERIMENTAL

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; Other: Non-Meal timing

Placebo

PLACEBO COMPARATOR

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; Other: Non-Meal timing

Interventions

Melatonin 1 mg 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 + Melatonin; Melatonin

Placebos 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 + Placebo; Placebo

Meal timing OTHER

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

Also known as: Extended overnight fasting (EOF)

Meal timing + Melatonin; Meal timing + Placebo

Non-Meal timing OTHER

Subjects are instructed to maintain their habitual meal timing.

Also known as: Non-extended overnight fasting (nEOF)

Melatonin; Placebo

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Interventions

Melatonin

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Phyllis Zee, MD, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Model Details: 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

Study Record Dates

• First Submitted: March 30, 2018
• First Posted: April 6, 2018
• Study Start: March 1, 2018
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: May 23, 2025

Record last verified: 2024-03

Locations

US (1)