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

NCT03457740 | Completed

• 1 other identifier: 18-0038
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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.

Conditions

Muscular Weakness; Sexual Behavior; Quality of Life

Keywords

muscular strength; testosterone; sexual function; quality of life

Outcome Measures

Primary Outcomes (1)

• Change in leg/back muscle strength

  Leg/lower back dynamometer test

  Change from baseline leg/back strength scores at 3 weeks, 6 weeks

Secondary Outcomes (6)

• Change in serum testosterone

  Change from baseline serum testosterone levels at 3 weeks, 6 weeks

• Change in sexual function

  Change from baseline CSFQ scores at 3 weeks, 6 weeks

• Change in quality of life

  Changes from baseline WHO-QOL scores at 3 weeks, 6 weeks

• Change in mood state

  Changes from baseline POMS scores at 3 weeks, 6 weeks

• Change in handgrip strength

  Changes from baseline handgrip strength scores at 3 weeks, 6 weeks.

Study Arms (3)

Formula 1

EXPERIMENTAL

Formula 1 with nutrients and herbs, 4 capsules daily, 6 weeks

Dietary Supplement: Formula 1

Formula 2

EXPERIMENTAL

Formula 2 with nutrients and herbs, 4 capsules daily, 6 weeks

Dietary Supplement: Formula 2

Placebo

PLACEBO COMPARATOR

Placebo, 4 capsules daily, 6 weeks

Dietary Supplement: Placebo

Interventions

Formula 1 DIETARY_SUPPLEMENT

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

Formula 1

Formula 2 DIETARY_SUPPLEMENT

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

Formula 2

Placebo DIETARY_SUPPLEMENT

Placebo comparison

Placebo

Eligibility Criteria

• Age: 40 Years - 70 Years
• Gender Eligibility Details: Based on self-representation of gender identity
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Appalachian State University: lead
• Purity Products: collaborator

Study Sites (1)

Appalachian State University Human Performance Lab, North Carolina Research Campus

Kannapolis, North Carolina, 28081, United States

Location

MeSH Terms

Conditions

Muscle Weakness; Sexual Behavior

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Behavior

Study Officials

• David C Nieman, DrPH

  Appalachian State Univ

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blind masking
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, parallel group, placebo controlled, double blind

Study Record Dates

• First Submitted: February 22, 2018
• First Posted: March 8, 2018
• Study Start: February 5, 2018
• Primary Completion: March 23, 2018
• Study Completion: April 20, 2018
• Last Updated: May 4, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)