Influence of Purity Product Supplements on Muscular Strength, Serum Testosterone Levels, Sexual Function, and Quality of Life

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)