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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 is a NA study that has completed, run by Albert Einstein College of Medicine. The registered enrollment target is 60 participants.

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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

Interventions

  • OTHER Ad libitum meal timing
  • OTHER Twice a day meals

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2019-06-20
Est. Completion 2022-06-16
Phase NA

Sponsor

Albert Einstein College of Medicine

175 total trials

What the Registry Record Tells You About NCT03809299

The ClinicalTrials.gov registry entry for NCT03809299 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Albert Einstein College of Medicine, which has 175 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Ad libitum meal timing is the first listed.

NCT03809299 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.