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NCT03457740 · ClinicalTrials.gov registry record · NA
Supplement Study: Strength, Testosterone, Sexual Function, Quality of Life
A NA study, sponsored by Appalachian State University.
- Completed
- Registry status
- NA
- Development phase
- 118
- Enrollment target
NCT03457740 is a NA study that has completed, run by Appalachian State University. The registered enrollment target is 118 participants.
The verdict
NCT03457740, a NA study, has completed, sponsored by Appalachian State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 118 participants
- Enrollment target
Study Summary
Decreased muscle mass (sarcopenia) and strength (dynapenia) are common during aging, with a rate of muscle mass loss that is approximately 6% per decade between 30 and 70 years of age. Muscle mass loss results in reduced strength and physical function (frailty), increased risk for falls and bone fractures, and decreased quality of life. The age-related decrease in testosterone plays a key role in the loss of muscle mass and strength for aging males. There is increasing interest in nutritional and exercise strategies to prevent aging-related losses in muscle mass and strength. Sexual dysfunction has a high prevalence among men (31%), and include erectile difficulties (10%), lack of interest in sex (9%), and inability to achieve orgasm (7%). There are multiple causes including low testosterone. There is growing interest in natural supplements, and this study will compare under double blind procedures two natural supplements with placebo (Men's Perfect Multi Formula and Andro Vitality) that have been formulated by Purity Products. The supplements contain micronutrients, plant extracts, and herbs, with the primary bioactives Rhaponticum carthamoides and magnesium. Rhaponticum carthamoides, commonly known as maral root or Russian leuzea, is a perennial herb that grows in South Siberia, and has been used to enhance muscular and sexual function, but more evidence from properly designed human trials is needed to determine both efficacy and safety. The purpose of this study using a randomized, parallel group design, is to evaluate the effect of two supplements relative to placebo on strength, serum free and total testosterone levels, sexual function, mood state, and quality of life compared to placebo over a 6-week period in 120 males.
Interventions
- DIETARY_SUPPLEMENT Placebo
- DIETARY_SUPPLEMENT Formula 1
- DIETARY_SUPPLEMENT Formula 2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 118 participants |
| Start Date | 2018-02-05 |
| Est. Completion | 2018-04-20 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03457740
The ClinicalTrials.gov registry entry for NCT03457740 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 118 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Appalachian State University, which has 37 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03457740 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03457740 about?
NCT03457740 is a clinical study titled "Supplement Study: Strength, Testosterone, Sexual Function, Quality of Life". Decreased muscle mass (sarcopenia) and strength (dynapenia) are common during aging, with a rate of muscle mass loss that is approximately 6% per decade between 30 and 70 years of age. Muscle mass loss results in reduced strength and physical function (frailty), increased risk for falls and bone fra...
What is the current status of trial NCT03457740?
This trial is currently completed. It is a NA study. The enrollment target is 118 participants. The study started on 2018-02-05. Estimated completion is 2018-04-20.
What interventions are being tested in trial NCT03457740?
The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), Formula 1 (DIETARY_SUPPLEMENT), Formula 2 (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT03457740?
This trial is sponsored by Appalachian State University, which has 37 total clinical trials registered on ClinicalTrials.gov.
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