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NCT03809299 · ClinicalTrials.gov registry record · NA
2-A-Day Study: Twice a Day Meals Study.
A NA study, sponsored by Albert Einstein College of Medicine.
- Completed
- Registry status
- NA
- Development phase
- 60
- Enrollment target
NCT03809299: Completed NA study, sponsored by Albert Einstein College of Medicine.
NCT03809299 is a NA study that has completed, run by Albert Einstein College of Medicine. The registered enrollment target is 60 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03809299, a NA study, has completed, sponsored by Albert Einstein College of Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
Study Summary
Caloric restriction increases lifespan and/or healthspan across multiple species. However implementation of long-term CR in humans is problematic and unacceptable to many individuals. As a result, intermittent fasting models have been developed to improve adherence. Such models have been shown to improve blood pressure, insulin sensitivity, decrease hepatic fat content and body weight. Investigators established an isocaloric twice-a-day (ITAD) feeding plan in mice, wherein test mice were acclimatized to consume over two hour periods (8-10am and 5-7pm), the same amount of food as ad-libitum mice. This intervention prevented obesity and age-associated type 2 diabetes via system-wide activation of autophagy. The investigators will perform further studies of the same feeding model in humans in a randomized crossover design. The objective is to test the hypothesis that restricting eating periods to twice a day (TAD), when compared to isocaloric ad lib meal timing (ALMT), will have beneficial effects on glucose metabolism, body composition, energy expenditure and autophagy in human subjects at risk for diabetes
Primary Outcome
insulin sensitivity as measured by the Matsuda Index
Interventions
- OTHER Ad libitum meal timing
- OTHER Twice a day meals
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2019-06-20 |
| Est. Completion | 2022-06-16 |
| Phase | NA |
What the finished NCT03809299 record still lists
NCT03809299 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Ad libitum meal timing is the first listed.
NCT03809299 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03809299 about?
NCT03809299 is a clinical study titled "2-A-Day Study: Twice a Day Meals Study.". Caloric restriction increases lifespan and/or healthspan across multiple species. However implementation of long-term CR in humans is problematic and unacceptable to many individuals. As a result, intermittent fasting models have been developed to improve adherence. Such models have been shown to im...
What is the current status of trial NCT03809299?
This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2019-06-20. Estimated completion is 2022-06-16.
What interventions are being tested in trial NCT03809299?
The interventions under investigation include: Ad libitum meal timing (OTHER), Twice a day meals (OTHER).
Who is sponsoring clinical trial NCT03809299?
This trial is sponsored by Albert Einstein College of Medicine, which has 175 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03809299's enrollment target sits among peer trials
60 1164th of 2000 higher than 745 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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