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NCT04495751 · ClinicalTrials.gov registry record · Early Phase 1
Muscadine Grape Extract to Improve Fatigue
A Early Phase 1 study of Fatigue, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 64
- Enrollment target
- 1
- Study location
NCT04495751: Completed Early Phase 1 study of Fatigue, sponsored by Wake Forest University Health Sciences.
NCT04495751 is a Early Phase 1 study of Fatigue that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 64 participants, below the 218-participant average among 109 other Fatigue trials with a reported enrollment target (71% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04495751, a Early Phase 1 study of Fatigue, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 64 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this research is to see if muscadine grape extract improves fatigue in people age 70 and above who have a history of treated cancer and report the symptom of fatigue.
Primary Outcome
(PROMIS) Fatigue 7a will be used to assess fatigue. Using a mixed effects model with a constraint of a common baseline mean across treatment groups and an unstructured covariance matrix to model all fatigue measures over time, and use linear contrasts to estimate the difference in change and corresponding 90% confidence interval between the two groups. Item responses are rated on a five-point scale ranging from "never" to "always" and are summed for a total score and transformed to a T-score met
Conditions Studied
Interventions
- DRUG Placebo
- OTHER Questionnaires
- OTHER Quality of Life Assessment
- DIETARY_SUPPLEMENT Muscadine grape extract
- OTHER Participant Feedback
Study Locations (1)
North Carolina
- Wake Forest Baptist Comprehensive Cancer Center - Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2021-04-20 |
| Est. Completion | 2024-08-26 |
| Phase | Early Phase 1 |
What the finished NCT04495751 record still lists
NCT04495751 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 218-participant average among 109 other Fatigue trials with a reported enrollment target (71% lower).
The record links to 1 condition, with Fatigue appearing as the primary indexed condition, and to 5 interventions - of which Placebo is the first listed.
NCT04495751 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT04495751 about?
NCT04495751 is a clinical study titled "Muscadine Grape Extract to Improve Fatigue". The purpose of this research is to see if muscadine grape extract improves fatigue in people age 70 and above who have a history of treated cancer and report the symptom of fatigue.
What is the current status of trial NCT04495751?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 64 participants. The study started on 2021-04-20. Estimated completion is 2024-08-26.
What conditions does trial NCT04495751 study?
This clinical trial studies the following conditions: Fatigue.
What interventions are being tested in trial NCT04495751?
The interventions under investigation include: Placebo (DRUG), Questionnaires (OTHER), Quality of Life Assessment (OTHER), Muscadine grape extract (DIETARY_SUPPLEMENT), Participant Feedback (OTHER).
Who is sponsoring clinical trial NCT04495751?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04495751 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Fatigue
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04495751's enrollment target sits among peer trials
64 55th of 109 higher than 55 of 109 other Fatigue trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Fatigue 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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