Status:

COMPLETED

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

Lead Sponsor:

Appalachian State University

Collaborating Sponsors:

Purity Products

Conditions:

Muscular Weakness

Sexual Behavior

Eligibility:

MALE

40-70 years

Phase:

NA

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 los...

Detailed Description

STUDY PARTICIPANT RECRUITMENT: Subjects will be recruited via mass advertising in the Charlotte Metropolitan area. Healthy subjects will be screened during recruitment to determine study eligibility ...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

February 5 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 20 2018

Estimated Enrollment :

118 Patients enrolled

Trial Details

Trial ID

NCT03457740

Start Date

February 5 2018

End Date

April 20 2018

Last Update

May 4 2018

Active Locations (1)

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Appalachian State University Human Performance Lab, North Carolina Research Campus

Kannapolis, North Carolina, United States, 28081