Supplement Study: Strength, Testosterone, Sexual Function, Quality of Life
Condition: Muscular Weakness; Sexual Behavior; Quality of Life
MeSH terms: Muscle Weakness
Study type: Interventional

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.
    

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 (via email and
      phone). The Charlotte metropolitan area is the largest in the Carolinas, and the sixth
      largest metropolitan area in the Southeastern region of the United States. Male participants
      40 to 70 years of age will be selected who match the listed inclusion and exclusion criteria
      (next page). The planned distribution of participants by racial/ethnic groups will reflect
      the demographics of the metropolitan area [White non-Hispanic (60%), Black non-Hispanic
      (24%), Hispanic (10%), and Asian or Pacific Islander non-Hispanic (3.5%)]. Those subjects who
      meet all of the inclusion criteria and none of the exclusion criteria will be enrolled and
      randomized into the study. The study duration for each subject will be 6 weeks. There will be
      a total of 3 visits for this study. Following recruitment, there will be a 2-week washout
      period for PDE5 medications. At each of the three morning visits (7:00-9:00 am), subjects
      will fill in the symptom log (retrospective 3-week period) and have their blood drawn to
      analyze serum levels of free and total testosterone, and to be tested for strength (isometric
      hand grip, leg/lower back, YMCA bench press) and body composition (8-point bioelectrical
      impedance). All subjects will be required to fast overnight for at least 9 hours prior to
      each visit. Subjects will also be required to abstain from all vigorous exercise and sexual
      activity at least 24-hours prior to each visit. Within three days prior to each lab visit,
      subjects will use Survey Monkey via the Internet to fill in responses to three
      questionnaires: CSFQ, WHO-QOL, and POMS.

      RESEARCH PLAN A. V1 - Baseline Visit - Week 0 Prior to the first lab visit, subjects will be
      recruited according to the listed inclusion and exclusion criteria. Subjects who agree to
      participate in the study, will be sent the Informed Consent Document (ICD) for review and
      signature. Subjects will fill in the Medical Health Questionnaire (MHQ) via Survey Monkey to
      obtain demographic, lifestyle, and medical histories. Following recruitment, there will be a
      2-week washout period for PDE5 medications. Within three days prior to the first lab visit,
      subjects will supply responses to the CSFQ, WHO-QOL, and POMS Questionnaires via Survey
      Monkey. The compensation contract will be reviewed and signed.

        -  Informed Consent: At the first lab visit (V1), all subjects will review the Informed
           Consent Document (ICD) that was previously sent via email attachment, and receive a
           signed copy.

        -  Questionnaires: Responses to the CSFQ, WHO-QOL, and POMS questionnaires sent prior to
           the first lab visit via Survey Monkey will be reviewed for completeness. Subjects will
           fill in the symptom log.

        -  Blood Sample: Subjects will have their blood drawn for analysis of free and total
           testosterone. Subjects will be asked to come in to the clinic during the early morning
           having fasted for at least 9 hours prior to the visit and refrained from having sexual
           intercourse 24 hours prior to the visit.

        -  Anthropometric and Strength Measures: Subjects will be measured for height and weight,
           and percent body fat using 8-point BIA. Handgrip and leg/lower back strength will be
           assessed with dynamometers (Figure 3). Subjects will also be tested for upper body
           strength using the YMCA bench press test (reps with 80-pound barbell set with a
           metronome for 30 lifts per minute).

        -  Randomization and Study Product Dispensing: Subjects will be assigned a randomization
           number, and receive a 3 week supply of the study product. The study product will be
           contained in supplement trays with specific dates and instructions applied. Subjects
           must return the supplement trays at the next two lab visits to verify compliance with
           the dosing regimen.

      B. V2 -Mid-Study Visit (Week 3)

        -  Retrieval Procedures: Subjects will return their supplement tray and any unused study
           product.

        -  Intercurrent Medical History and Concomitant Medication History: Subjects will be
           interviewed by the clinic staff to determine whether there have been any changes in
           their medical history, whether they have started taking any new medications.

        -  Questionnaires: Responses to the CSFQ, WHO-QOL, and POMS questionnaires sent within
           3-days prior to the second visit via Survey Monkey will be reviewed for completeness.
           Subjects will fill in the symptom log (3 week retrospective).

        -  Blood Sample: Subjects will have their blood drawn for analysis of free and total
           testosterone. Subjects will be asked to come in to the clinic during the early morning
           having fasted for at least 9 hours prior to the visit and refrained from having sexual
           intercourse and all exercise 24 hours prior to the visit.

        -  Anthropometric and Strength Measures: Subjects will be measured for weight, and percent
           body fat using 8-point BIA. Handgrip and leg/lower back strength will be assessed with
           dynamometers, and upper body strength with the YMCA bench press test.

        -  Study Product Dispensing: Subjects will receive their final 3-week supply of the study
           supplements. Subjects must return the supplement tray at the final lab visit to verify
           compliance with the dosing regimen.

      C. V3 -End-of-Study Visit (Week 6)

        -  Retrieval Procedures: Subjects will return their supplement tray and any unused study
           product.

        -  Intercurrent Medical History and Concomitant Medication History: Subjects will be
           interviewed by the clinic staff to determine whether there have been any changes in
           their medical history, whether they have started taking any new medications.

        -  Questionnaires: Responses to the CSFQ, WHO-QOL, and POMS questionnaires sent within 3
           days prior to the final lab visit via Survey Monkey will be reviewed for completeness.
           The final symptom log will be completed. The compensation contract will be reviewed.

        -  Blood Sample: Subjects will have their blood drawn for analysis of free and total
           testosterone. Subjects will be asked to come in to the clinic during the early morning
           having fasted for at least 9 hours prior to the visit and refrained from having sexual
           intercourse 24 hours prior to the visit.

        -  Anthropometric and Strength Measures: Subjects will be measured for height and weight,
           and percent body fat using 8-point BIA. Handgrip and leg/lower back strength will be
           assessed with dynamometers, and upper body strength with the YMCA bench press test.

      D. Investigational Study Products Formula 1 - a Men's Perfect Multi Formula boosted by extra
      Magnesium and key vitamins and co-factors. 4 tablets.

      Formula 2 - an Herbal blend - we're naming "AndroVitality" with Rhaponticum, Rhododendron
      caucasicum, 180 mg magnesium, 10 zinc and 2000 IU vitamin D. 4 tablets.

      INSTRUCTIONS: Take 4 capsules daily, with water on an empty stomach. If the study participant
      reports that they get an upset stomach from ingesting the capsules, they will be allowed to
      consume a small snack. The investigators will store the study product in a locked cabinet in
      a limited access room, in accordance with the manufacturer's instructions, i.e. in a dry
      place and at room temperature. Purity Products will provide the ASU-NCRC Human Performance
      Lab with sufficient study product to complete this study. The supplements and placebo
      product, will be supplied to the Primary Investigator (DCN) in boxes using A, B, and C codes
      so that both the investigators and the subjects will be blinded regarding the type of
      supplement being ingested. Supplement trays will be given to each subject, and will contain
      labels with the following information:

        -  Study code number

        -  Patient number

        -  Directions of use

        -  Storage instructions

      E. Concomitant Medication Prohibited Medications and Interventions

      The following products and interventions are not permitted while the subject is in this
      study:

      · No erectile dysfunction medications or dietary supplements containing ingredients
      advertised for influences on sexual function or testosterone.

      F. Data Analysis and Statistical Methods Data will be entered into an Excel worksheet under
      the direction of the Primary Investigator (DCN) and the Research Manager. Data statistical
      analysis (with identifier information deleted) will be conducted by Drs. Nieman, Canu, and
      Broman-Fulks. The basic statistical model will be a 3 (group) x 3 (time) repeated measures
      ANOVA within the SPSS Generalized Linear Model (GLM). Subjects will be randomized in equal
      numbers to one of three groups: two supplement groups; Placebo. The blinding code will be
      created by Purity Products and stored in a locked cabinet, and provided to the Primary
      Investigator AFTER all data have been collected. The file linking ID numbers and names of
      study participants will be stored at uStor, the secure storage site for Appalachian State
      University (http://ustorcloud.appstate.edu). Analysis and interpretation of data from the
      CSFQ, WHO-QOL, and POMS questionnaires will be under the direction of clinical psychologists
      Drs. Canu and Broman-Fulks. Prior to the initiation of the study, this protocol including the
      informed consent form will be submitted to the ASU IRB and the trial will not start until
      unconditional approval is received. All guidelines from the ASU IRB for protection of
      personal data will be followed. The Primary Investigator will assign a subject number to each
      subject that will be used for identification whenever subject related data are recorded for
      the sponsor or reported. Subjects who are randomized, but drop out prior to completing the
      study will be recorded. A record of reasons why subjects drop out of the study will be
      maintained. After data analysis the Primary Investigator will summarize the results in a
      final report which accurately reflects the clinical data of this study.
    

Intervention name(s): Formula 1; Formula 2; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Dietary supplement for strength, testosterone, sexual function, quality of life; Dietary supplement for strength, testosterone, sexual function, quality of life; Placebo comparison
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, parallel group, placebo controlled, double blind
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: muscular strength; testosterone; sexual function; quality of life