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NCT03490864 · ClinicalTrials.gov registry record · NA
Strengthening Circadian Signals
A NA study of Improving Cardiometabolic Outcomes in Adults, sponsored by Northwestern University.
- Completed
- Registry status
- NA
- Development phase
- 43
- Enrollment target
- 1
- Study location
NCT03490864 is a NA study of Improving Cardiometabolic Outcomes in Adults that has completed, run by Northwestern University. The registered enrollment target is 43 participants. The trial reports 1 study location across 1 state.
The verdict
NCT03490864, a NA study of Improving Cardiometabolic Outcomes in Adults, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- NA
- Development phase
- 43 participants
- Enrollment target
- 1
- Study location
Study Summary
There is a growing body of evidence from both laboratory and field studies that disrupted circadian function, particularly decreased amplitude and stability of rhythmic behaviors represent significant risk factors for cardiometabolic disease (CMD) in humans. The exciting evidence of the ubiquity of circadian clocks in all tissues and their critical role in metabolism, not only opens up new avenues for understanding the mechanistic interactions between central and peripheral clocks in cardiometabolic disease pathogenesis, but also to develop therapeutic interventions to re-establish synchrony between central and peripheral clocks with each other and with the external physical and social environments. Feeding has been shown to synchronize clocks in peripheral tissues. Animal studies have demonstrated that restricting feeding to the active period decreases CMD risk, while in humans decreased caloric intake in the evening is associated with a lower body mass index (BMI). The amplitude of melatonin can be considered a marker of robustness of central circadian function, but melatonin also has physiological effects beyond circadian regulation throughout the body. Recent observations have demonstrated that having a low melatonin level is a risk factor for incident diabetes and hypertension independent of sleep duration. Together, the evidence suggests that strategies aimed at synchronizing feeding behavior and enhancing the nocturnal melatonin signal can positively impact cardiometabolic function. We propose to take an innovative approach that combines the recent data on the role of feed/fast patterns on clock regulated metabolic activity and the reemergence of scientific interest of the central and peripheral effects of melatonin on cardiometabolic function to elucidate the physiological and molecular mechanisms that underlie the relationship between circadian dysregulation and obesity associated CMD risk. This will be accomplished by strengthening the amplitude of circad
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 | 43 participants |
| Start Date | 2018-05-16 |
| Est. Completion | 2024-07-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03490864
The ClinicalTrials.gov registry entry for NCT03490864 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Improving Cardiometabolic Outcomes in Adults appearing as the primary indexed condition, and to 4 interventions - of which Melatonin 1 mg is the first listed.
NCT03490864 reports 1 study location spanning 1 distinct geographic area - top geographies include Illinois.
Frequently Asked Questions
What is clinical trial NCT03490864 about?
NCT03490864 is a clinical study titled "Strengthening Circadian Signals". There is a growing body of evidence from both laboratory and field studies that disrupted circadian function, particularly decreased amplitude and stability of rhythmic behaviors represent significant risk factors for cardiometabolic disease (CMD) in humans. The exciting evidence of the ubiquity of ...
What is the current status of trial NCT03490864?
This trial is currently completed. It is a NA study. The enrollment target is 43 participants. The study started on 2018-05-16. Estimated completion is 2024-07-31.
What conditions does trial NCT03490864 study?
This clinical trial studies the following conditions: Improving Cardiometabolic Outcomes in Adults.
What interventions are being tested in trial NCT03490864?
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 NCT03490864?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03490864 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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