Skip to main content
OpenTrials
Completed

NCT Number: NCT03490825

Aging Program Project Grant 6

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

55 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

Other

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

Other names: Extended overnight fasting (EOF)

Non-Meal timing

Other

Subjects are instructed to maintain their habitual meal timing.

Other names: Non-extended overnight fasting (nEOF)

Primary outcomes

  1. Matsuda Index

    Time frame: 8 weeks

    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.

  2. Nocturnal Blood Pressure Dipping

    Time frame: 8 weeks

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

  3. Melatonin Amplitude

    Time frame: 8 weeks

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

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

Enhancing Circadian Signal to Improve Cardiometabolic Function in Aging

Acronym: PPG6

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Apr 6, 2018
Registry last updated
May 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.