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NCT03365531 · ClinicalTrials.gov registry record · NA
RCT of Caloric Restriction vs. Alternate-Day Fasting in Non-Alcoholic Fatty Liver Disease
A NA study, sponsored by University of Florida.
- Terminated
- Registry status
- NA
- Development phase
- 7
- Enrollment target
NCT03365531: Clinical Trial NA study, sponsored by University of Florida.
NCT03365531 is a NA study that was terminated before completion, run by University of Florida. The registered enrollment target is 7 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03365531, a NA study, was terminated before completion, sponsored by University of Florida.
- TERMINATED
- Registry status
- NA
- Development phase
- 7 participants
- Enrollment target
Study Summary
Non-alcoholic fatty liver disease (NAFLD) in patients with diabetes (T2DM) is increasing in prevalence and can lead to cirrhosis. Lifestyle intervention with caloric restriction (CR) is the cornerstone of treatment but remission is variable. Alternatively, the PI has shown alternate day fasting (ADF) is safe and well tolerated in obese patients and there might be additional beneficial effects. The objective is to combine the expertise of the PI with this novel intervention and the expertise of Dr. Cusi in NAFLD to explore the effects of ADF vs CR in patients with NAFLD and T2DM to test the following hypotheses: H1: In patients with NAFLD and T2DM, the ADF intervention will result in more favorable metabolic changes than CR: H1a: Hepatic triglyceride by MRS will decrease more with ADF than CR (Primary Outcome) and remain lower following a period of free living H1b: There will be greater improvements in glucose homeostasis following ADF vs CR H1c: There will be greater improvement in lipid metabolism following ADF vs CR and changes in ketone metabolism will predict changes in hepatic triglyceride content H2: ADF will have similar safety and tolerability and result in a similar degree of weight loss in participants with NAFLD and DM compared to CR
Primary Outcome
To determine changes in hepatic triglyceride by MRS after 4 weeks of ADF (Primary outcome) and after 4 weeks of ad lib diet
Interventions
- OTHER Alternate Daily Fasting (ADF)
- OTHER Caloric Restriction (CR)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2018-03-01 |
| Est. Completion | 2019-07-01 |
| Phase | NA |
Why NCT03365531 stopped before completion
NCT03365531 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 2 interventions - of which Alternate Daily Fasting (ADF) is the first listed.
NCT03365531 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03365531 about?
NCT03365531 is a clinical study titled "RCT of Caloric Restriction vs. Alternate-Day Fasting in Non-Alcoholic Fatty Liver Disease". Non-alcoholic fatty liver disease (NAFLD) in patients with diabetes (T2DM) is increasing in prevalence and can lead to cirrhosis. Lifestyle intervention with caloric restriction (CR) is the cornerstone of treatment but remission is variable. Alternatively, the PI has shown alternate day fasting (ADF...
What is the current status of trial NCT03365531?
This trial is currently terminated. It is a NA study. The enrollment target is 7 participants. The study started on 2018-03-01. Estimated completion is 2019-07-01.
What interventions are being tested in trial NCT03365531?
The interventions under investigation include: Alternate Daily Fasting (ADF) (OTHER), Caloric Restriction (CR) (OTHER).
Who is sponsoring clinical trial NCT03365531?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03365531's enrollment target sits among peer trials
7 1982nd of 2000 higher than 18 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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