NCT03457740

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

Completed NA Last updated 4 May 2018

What this trial tests

NA trial testing Formula 1 in Muscular Weakness in 118 participants. Completed in 20 April 2018.

Timeline

5 February 2018

Primary endpoint
23 March 2018

20 April 2018

Quick facts

Lead sponsor	Appalachian State University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	118
Start date	5 February 2018
Primary completion	23 March 2018
Estimated completion	20 April 2018
Sites	1 location across United States

Drugs / interventions tested

• Formula 1
• Formula 2
• Placebo

Conditions studied

• Muscular Weakness — all drugs for Muscular Weakness →
• Sexual Behavior — all drugs for Sexual Behavior →
• Quality of Life — all drugs for Quality of Life →

Sponsor

Appalachian State University

Who can join

Adults 40 to 70, male only, with Muscular Weakness or Sexual Behavior. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.