Supplement Study: Strength, Testosterone, Sexual Function, Quality of Life
| Status: | Completed |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 40 - 70 |
| Updated: | 5/6/2018 |
| Start Date: | February 5, 2018 |
| End Date: | April 20, 2018 |
Influence of Purity Product Supplements on Muscular Strength, Serum Testosterone Levels, Sexual Function, and Quality of Life
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.
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.
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.
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.
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.
We found this trial at
1
site
Kannapolis, North Carolina 28081
Principal Investigator: David Nieman, DrPH
Phone: 828-773-0056
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