Improving Cardiometabolic Outcomes in Older AdultsPPG6NCT03490825
Aging Program Project Grant 6
A study testing Melatonin 1 mg, Meal timing and Non-Meal timing in people with Improving Cardiometabolic Outcomes in Older Adults, run by Northwestern University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Improving Cardiometabolic Outcomes in Older Adults
- What is being tested?
- Melatonin 1 mg, Meal timing and Non-Meal timing
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2018to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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)
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhancing Circadian Signal to Improve Cardiometabolic Function in Aging
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.
- Being tested
- Melatonin 1 mg, Placebos, Meal timing, Non-Meal timing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melatonin 1 mgDietary 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.
PlacebosDietary 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 timingOther
Also called Extended overnight fasting (EOF)
Subjects are instructed to maintain an extended overnight fasting period of 12-16 hours.
Non-Meal timingOther
Also called Non-extended overnight fasting (nEOF)
Subjects are instructed to maintain their habitual meal timing.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Dietary Supplement: Placebos; Other: Non-Meal timing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Nocturnal Blood Pressure Dipping
Defined as a ratio of sleep blood pressure to wake blood pressure less than 0.90.
Measured: 8 weeks
Melatonin Amplitude
The melatonin amplitude will be calculated to determine the effects of the interventions on sleep and CMD outcomes.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2018
- Study start1 Mar 2018
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Improving Cardiometabolic Outcomes in Older AdultsStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Phyllis Zee, Northwestern University
- Investigators
- Phyllis Zee, MD, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03490825
- Sponsor's protocol ID
- STU00206014
- Acronym
- PPG6
- Status last verified
- Mar 2024
- First submitted
- 30 Mar 2018
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Circadian Signal to Improve Cardiometabolic Function in Aging
- ClinicalTrials.gov ID
- NCT03490825
- Acronym / sponsor ID
- PPG6 / STU00206014
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 6 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- 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
| Arm | Type | Receives |
|---|---|---|
| Meal timing + Melatonin | Experimental | Dietary Supplement: Melatonin 1 mg, Other: Meal timingThis 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. |
| Meal timing + Placebo | Experimental | Dietary Supplement: Placebos, Other: Meal timingThis 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. |
| Melatonin | Experimental | Dietary Supplement: Melatonin 1 mg, Other: Non-Meal timingThis 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. |
| Placebo | Placebo comparator | Dietary Supplement: Placebos, Other: Non-Meal timingThis 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. |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Melatonin 1 mgMelatonin (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. | Dietary supplement | Meal timing + Melatonin, Melatonin |
| PlacebosPlacebo 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. | Dietary supplement | Meal timing + Placebo, Placebo |
| Meal timingAlso: Extended overnight fasting (EOF)Subjects are instructed to maintain an extended overnight fasting period of 12-16 hours. | Other | Meal timing + Melatonin, Meal timing + Placebo |
| Non-Meal timingAlso: Non-extended overnight fasting (nEOF)Subjects are instructed to maintain their habitual meal timing. | Other | Melatonin, Placebo |
Primary outcome
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.
Nocturnal Blood Pressure Dipping
Time frame: 8 weeks
Defined as a ratio of sleep blood pressure to wake blood pressure less than 0.90.
Melatonin Amplitude
Time frame: 8 weeks
The melatonin amplitude will be calculated to determine the effects of the interventions on sleep and CMD outcomes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Phyllis Zee, MD, PhD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Melatonin 1 mg, Meal timing and Non-Meal timing in people with Improving Cardiometabolic Outcomes in Older Adults, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Matsuda Index (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.