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

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.

Conditions

• Muscular Weakness
• Sexual Behavior
• Quality of Life

Interventions

DIETARY_SUPPLEMENT

Formula 1

Dietary supplement for strength, testosterone, sexual function, quality of life

DIETARY_SUPPLEMENT

Formula 2

Dietary supplement for strength, testosterone, sexual function, quality of life

DIETARY_SUPPLEMENT

Placebo

Placebo comparison

Sponsors & Collaborators

• Purity Products

  collaborator UNKNOWN

• Appalachian State University

  lead OTHER

Principal Investigators

• David C Nieman, DrPH · Appalachian State Univ

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

70 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-02-05

Primary Completion

2018-03-23

Completion

2018-04-20

Countries

• United States

Study Locations