Supplement Study: Strength, Testosterone, Sexual Function, Quality of Life

Completed · Not applicable · Has a placebo group

Conditions studied: Muscular Weakness, Sexual Behavior, Quality of Life

In brief

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.

Key facts

Study ID: NCT03457740
Run by: Appalachian State University
People needed: 118
Starts: 2018-02-05
Expected to finish: 2018-04-20
Last updated by the study team: 2018-05-04

Who can join

Age: 40 and older, up to 70. Sex: male. Healthy volunteers: accepted.

You may qualify if…

Male, 40 to 70 years of age.
In a stable relationship during at least the past 3 months, with active sexual relations, and an anticipated stable sexual relationship during the 6-week study period.
Non-diseased, and in general good health on the basis of medical history.
Low level of weight lifting in a gym or club setting (history of resistance training less than an average of once per week during the previous 6 months).
Willingness to maintain current exercise and diet habits during the study.
No history of a bleeding disorder (e.g., von Willebrand Disease) or current use of medications that affect clotting in the blood.

You may not qualify if…

History of prostate cancer or any physical disability that limits sexual function.
Receiving any treatment/therapy for sexual disorders during the past 6 months.
Currently using Viagra, Cialis or Levitra (or similar products), or unwillingness to quit use two weeks prior to the start of the study.
Currently using dietary supplements with ingredients advertised for their influence on muscle strength, sexual function, or testosterone, or unwillingness to quit use two weeks prior to the start of the study.
Current personal history of psychiatric illness and/or use of treatment medications.
Current alcohol and/or drug abuse.
Current history of bleeding disorder (e.g., von Willebrand Disease) or use of anti-clotting medication.
Scheduled surgery during the study or within 2 weeks after the study is over.

Where it is running

Appalachian State University Human Performance Lab, North Carolina Research Campus — Kannapolis, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.