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NCT04821401 · ClinicalTrials.gov registry record · NA
Rejuvant™ Safety and Biomarker Study
A NA study of Aging Well, sponsored by Ponce De Leon Health.
- Completed
- Registry status
- NA
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT04821401: Completed NA study of Aging Well, sponsored by Ponce De Leon Health.
NCT04821401 is a NA study of Aging Well that has completed, run by Ponce De Leon Health. The registered enrollment target is 100 participants, above the 57-participant average among 7 other Aging Well trials with a reported enrollment target (75% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04821401, a NA study of Aging Well, has completed, sponsored by Ponce De Leon Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study Summary
In this randomized, double-blind, placebo-controlled trial in adult men ages 45-65 years and postmenopausal women to age 75 years, the anti-inflammatory property of proprietary CaAKG based dietary supplements will be assessed by the measurement of C-reactive protein (CRP) as the primary endpoint. Secondary safety endpoints will be assessed by monitoring blood chemistry results and recorded adverse effects. In addition, the biological age of the participants will be determined by the level of DNA methylation measured from saliva samples. An open label Sub-Study was conducted on eligible and consenting subjects who were assigned to the placebo. Assessments and endpoints remained the same as for the main study.
Primary Outcome
The primary objective is to observe the effect, if any, of Rejuvant products on the C-reactive protein level (CRP, hs-CRP). These tests will be done at Day 1, Month 3, Month 6, and Month 9
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Placebo
- DIETARY_SUPPLEMENT Rejuvant
Study Locations (1)
Indiana
- Indiana University School of Medicine - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2020-02-07 |
| Est. Completion | 2022-02-14 |
| Phase | NA |
What the finished NCT04821401 record still lists
NCT04821401 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, above the 57-participant average among 7 other Aging Well trials with a reported enrollment target (75% higher).
The record links to 1 condition, with Aging Well appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04821401 reports a single indexed study location in Indiana.
Frequently Asked Questions
What is clinical trial NCT04821401 about?
NCT04821401 is a clinical study titled "Rejuvant™ Safety and Biomarker Study". In this randomized, double-blind, placebo-controlled trial in adult men ages 45-65 years and postmenopausal women to age 75 years, the anti-inflammatory property of proprietary CaAKG based dietary supplements will be assessed by the measurement of C-reactive protein (CRP) as the primary endpoint. Se...
What is the current status of trial NCT04821401?
This trial is currently completed. It is a NA study. The enrollment target is 100 participants. The study started on 2020-02-07. Estimated completion is 2022-02-14.
What conditions does trial NCT04821401 study?
This clinical trial studies the following conditions: Aging Well.
What interventions are being tested in trial NCT04821401?
The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), Rejuvant (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT04821401?
This trial is sponsored by Ponce De Leon Health, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04821401 being conducted?
This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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