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NCT02915237 · ClinicalTrials.gov registry record · Phase 1
Development of a Polyphenol-rich Dietary Preparation for Treating Veterans With Gulf War Illness
A Phase 1 study, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
NCT02915237: Completed Phase 1 study, sponsored by Icahn School of Medicine at Mount Sinai.
NCT02915237 is a Phase 1 study that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 36 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02915237, a Phase 1 study, has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
Study Summary
Gulf War Illness (GWI) is a multi-symptom disorder that is characterized by complex traits such as fatigue, headaches, joint pain, insomnia, and memory problems. With no treatment for GWI currently available, there is an urgent need to develop novel interventions to alleviate major GWI clinical complications. Recent evidence highlights the potential value of flavonoids, a subclass of organic chemical called polyphenols abundantly found in some plants and common dietary preparations, in helping relieve clinical complications in Veterans with GWI. The overall goal is to test whether daily consumption of commercially available Concord grape juice, which is very Flavonoid-rich, is effective for treating cognitive deficits and chronic fatigue in Veterans with GWI.
Primary Outcome
to assess safety and tolerability to treatment. The test is a 53-item self report scale that uses the 5 point Likert scale.
Interventions
- DIETARY_SUPPLEMENT Concord grape juice
- DIETARY_SUPPLEMENT Placebo Beverage
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2016-08 |
| Est. Completion | 2019-01-17 |
| Phase | Phase 1 |
What the finished NCT02915237 record still lists
NCT02915237 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 2 interventions - of which Concord grape juice is the first listed.
NCT02915237 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02915237 about?
NCT02915237 is a clinical study titled "Development of a Polyphenol-rich Dietary Preparation for Treating Veterans With Gulf War Illness". Gulf War Illness (GWI) is a multi-symptom disorder that is characterized by complex traits such as fatigue, headaches, joint pain, insomnia, and memory problems. With no treatment for GWI currently available, there is an urgent need to develop novel interventions to alleviate major GWI clinical comp...
What is the current status of trial NCT02915237?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2016-08. Estimated completion is 2019-01-17.
What interventions are being tested in trial NCT02915237?
The interventions under investigation include: Concord grape juice (DIETARY_SUPPLEMENT), Placebo Beverage (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT02915237?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02915237's enrollment target sits among peer trials
36 1210th of 2000 higher than 743 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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