We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03457740
Recruitment Status : Completed
First Posted : March 8, 2018
Last Update Posted : May 4, 2018
Purity Products
Information provided by (Responsible Party):
Appalachian State University

Brief 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.

Condition or disease Intervention/treatment Phase
Muscular Weakness Sexual Behavior Quality of Life Dietary Supplement: Formula 1 Dietary Supplement: Formula 2 Dietary Supplement: Placebo Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, parallel group, placebo controlled, double blind
Masking: Double (Participant, Investigator)
Masking Description: Double blind masking
Primary Purpose: Prevention
Official Title: Influence of Purity Product Supplements on Muscular Strength, Serum Testosterone Levels, Sexual Function, and Quality of Life
Actual Study Start Date : February 5, 2018
Actual Primary Completion Date : March 23, 2018
Actual Study Completion Date : April 20, 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Formula 1
Formula 1 with nutrients and herbs, 4 capsules daily, 6 weeks
Dietary Supplement: Formula 1
Dietary supplement for strength, testosterone, sexual function, quality of life

Experimental: Formula 2
Formula 2 with nutrients and herbs, 4 capsules daily, 6 weeks
Dietary Supplement: Formula 2
Dietary supplement for strength, testosterone, sexual function, quality of life

Placebo Comparator: Placebo
Placebo, 4 capsules daily, 6 weeks
Dietary Supplement: Placebo
Placebo comparison

Primary Outcome Measures :
  1. Change in leg/back muscle strength [ Time Frame: Change from baseline leg/back strength scores at 3 weeks, 6 weeks ]
    Leg/lower back dynamometer test

Secondary Outcome Measures :
  1. Change in serum testosterone [ Time Frame: Change from baseline serum testosterone levels at 3 weeks, 6 weeks ]
    Changes in free and total serum testosterone levels

  2. Change in sexual function [ Time Frame: Change from baseline CSFQ scores at 3 weeks, 6 weeks ]
    Changes in Sexual Functioning Questionnaire (CSFQ) scores

  3. Change in quality of life [ Time Frame: Changes from baseline WHO-QOL scores at 3 weeks, 6 weeks ]
    Changes in World Health Organization Quality of Life (WHO-QOL) scores

  4. Change in mood state [ Time Frame: Changes from baseline POMS scores at 3 weeks, 6 weeks ]
    Changes in Profile of Mood States (POMS) scores

  5. Change in handgrip strength [ Time Frame: Changes from baseline handgrip strength scores at 3 weeks, 6 weeks. ]
    Changes in handgrip dynamometer strength

  6. Change in bench press muscular endurance [ Time Frame: Changes from baseline bench press repetitions at 3 weeks, 6 weeks ]
    Changes in bench press repetitions

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Based on self-representation of gender identity
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03457740

Layout table for location information
United States, North Carolina
Appalachian State University Human Performance Lab, North Carolina Research Campus
Kannapolis, North Carolina, United States, 28081
Sponsors and Collaborators
Appalachian State University
Purity Products
Layout table for investigator information
Principal Investigator: David C Nieman, DrPH Appalachian State Univ
Layout table for additonal information
Responsible Party: Appalachian State University
ClinicalTrials.gov Identifier: NCT03457740    
Other Study ID Numbers: 18-0038
First Posted: March 8, 2018    Key Record Dates
Last Update Posted: May 4, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Will depend on journal that publishes the data.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Appalachian State University:
muscular strength
sexual function
quality of life
Additional relevant MeSH terms:
Layout table for MeSH terms
Muscle Weakness
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes