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NCT03513523 · ClinicalTrials.gov registry record · NA
Study to Assess the Relationship Between Daily Dosing of NRPT and Changes in Liver Fat in Healthy Volunteers
A NA study of Fatty Liver, sponsored by Elysium Health.
- Completed
- Registry status
- NA
- Development phase
- 111
- Enrollment target
- 9
- Study locations
NCT03513523: Completed NA study of Fatty Liver, sponsored by Elysium Health.
NCT03513523 is a NA study of Fatty Liver that has completed, run by Elysium Health. The registered enrollment target is 111 participants, below the 205-participant average among 20 other Fatty Liver trials with a reported enrollment target (46% lower). The trial reports 9 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03513523, a NA study of Fatty Liver, has completed, sponsored by Elysium Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 111 participants
- Enrollment target
- 9
- Study locations
Study Summary
The purpose of this study is to determine if there is a relationship between daily consumption of NRPT, over a six-month (26-week) period, and changes in liver fat accumulation, compared to placebo and change from Baseline in healthy volunteers. In addition, an exploratory assessment of markers of inflammation and liver fat metabolism will be examined.
Primary Outcome
Change from Baseline in Fatty Liver Index (FLI) will be evaluated within each subject and compared between treatment groups. FLI: = (e\^0.953\*loge (triglycerides) + 0.139\*BMI + 0.718\*loge (GGT) + 0.053\*waist circumference - 15.745) / (1 + e\^0.953\*loge (triglycerides) + 0.139\*BMI + 0.718\*loge (GGT) + 0.053\*waist circumference - 15.745) \* 100.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Group 1 NRPT
- DIETARY_SUPPLEMENT Group 2 NRPT
- OTHER Group 3 Placebo
Study Locations (9)
Florida
- Indago Research and Health Center - Hialeah
- Altus Research, Inc. - Lake Worth
- Lone Star Research Center - Miami
- Med-Care Research Corp - Miami
- Legacy Clinical Solutions: Sensible Healthcare, LLC - Ocoee
- IMIC, Inc - Palmetto Bay
- Lenus Research & Medical Group - Sweetwater
Nebraska
- Barrett Clinic, P.C. - La Vista
North Carolina
- Trial Management Associates, LLC - Wilmington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 111 participants |
| Start Date | 2018-04-18 |
| Est. Completion | 2020-08-17 |
| Phase | NA |
What the finished NCT03513523 record still lists
NCT03513523 is an interventional study that assigns participants to a tested intervention. The registered 111 participants enrollment target is mid-sized for trials with a published cap, below the 205-participant average among 20 other Fatty Liver trials with a reported enrollment target (46% lower).
The record links to 1 condition, with Fatty Liver appearing as the primary indexed condition, and to 3 interventions - of which Group 1 NRPT is the first listed.
NCT03513523 lists 9 locations in 3 states (Florida, Nebraska, North Carolina).
Frequently Asked Questions
What is clinical trial NCT03513523 about?
NCT03513523 is a clinical study titled "Study to Assess the Relationship Between Daily Dosing of NRPT and Changes in Liver Fat in Healthy Volunteers". The purpose of this study is to determine if there is a relationship between daily consumption of NRPT, over a six-month (26-week) period, and changes in liver fat accumulation, compared to placebo and change from Baseline in healthy volunteers. In addition, an exploratory assessment of markers of i...
What is the current status of trial NCT03513523?
This trial is currently completed. It is a NA study. The enrollment target is 111 participants. The study started on 2018-04-18. Estimated completion is 2020-08-17.
What conditions does trial NCT03513523 study?
This clinical trial studies the following conditions: Fatty Liver.
What interventions are being tested in trial NCT03513523?
The interventions under investigation include: Group 1 NRPT (DIETARY_SUPPLEMENT), Group 2 NRPT (DIETARY_SUPPLEMENT), Group 3 Placebo (OTHER).
Who is sponsoring clinical trial NCT03513523?
This trial is sponsored by Elysium Health, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03513523 being conducted?
This trial has 9 study locations across Florida, Nebraska, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT03513523's enrollment target sits among peer trials
111 7th of 20 higher than 14 of 20 other Fatty Liver trials
participants (enrollment target), bucketed by value
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