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NCT03490825 · ClinicalTrials.gov registry record · NA
Aging Program Project Grant 6
A NA study of Improving Cardiometabolic Outcomes in Older Adults, sponsored by Northwestern University.
- Completed
- Registry status
- NA
- Development phase
- 32
- Enrollment target
- 1
- Study location
NCT03490825: Completed NA study of Improving Cardiometabolic Outcomes in Older Adults, sponsored by Northwestern University.
NCT03490825 is a NA study of Improving Cardiometabolic Outcomes in Older Adults that has completed, run by Northwestern University. The registered enrollment target is 32 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03490825, a NA study of Improving Cardiometabolic Outcomes in Older Adults, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- NA
- Development phase
- 32 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Melatonin 1 mg
- DIETARY_SUPPLEMENT Placebos
- OTHER Meal timing
- OTHER Non-Meal timing
Study Locations (1)
Illinois
- Northwestern University - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2018-03-01 |
| Est. Completion | 2024-05-31 |
| Phase | NA |
What the finished NCT03490825 record still lists
NCT03490825 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Improving Cardiometabolic Outcomes in Older Adults appearing as the primary indexed condition, and to 4 interventions - of which Melatonin 1 mg is the first listed.
NCT03490825 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT03490825 about?
NCT03490825 is a clinical study titled "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 publ...
What is the current status of trial NCT03490825?
This trial is currently completed. It is a NA study. The enrollment target is 32 participants. The study started on 2018-03-01. Estimated completion is 2024-05-31.
What conditions does trial NCT03490825 study?
This clinical trial studies the following conditions: Improving Cardiometabolic Outcomes in Older Adults.
What interventions are being tested in trial NCT03490825?
The interventions under investigation include: Melatonin 1 mg (DIETARY_SUPPLEMENT), Placebos (DIETARY_SUPPLEMENT), Meal timing (OTHER), Non-Meal timing (OTHER).
Who is sponsoring clinical trial NCT03490825?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03490825 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03490825's enrollment target sits among peer trials
32 1578th of 2000 higher than 409 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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