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A Study to Evaluate the Effects of a Prostate Health Formulation

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Supplement Formulators, Inc.
Sponsor:
Information provided by (Responsible Party):
Supplement Formulators, Inc.
ClinicalTrials.gov Identifier:
NCT02886832
First received: August 29, 2016
Last updated: August 31, 2016
Last verified: August 2016
  Purpose
The purpose of this study is to assess the efficacy of a Prostate Health formulation on scores attained from the I-PSS questionnaire. Safety and tolerability of the formulation will also be assessed.

Condition Intervention
Prostate Health
Dietary Supplement: Prostate Health formulation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: A Pilot, Open-label Study to Evaluate the Effects of a Prostate Health Formulation on Scores Attained From the International Prostate Symptom Score (I-PSS) Questionnaire Among Overall Healthy Male Participants Who Report Lower Urinary Tract Complaints

Further study details as provided by Supplement Formulators, Inc.:

Primary Outcome Measures:
  • Mean change on I-PSS score [ Time Frame: 60 days ]

Secondary Outcome Measures:
  • Mean change on the I-PSS Quality of Life question score [ Time Frame: 60 days ]
  • Mean change in the PSA level [ Time Frame: 60 days ]
  • Mean change on the IIEF-5 questionnaire score [ Time Frame: 60 days ]
  • Mean change in body weight [ Time Frame: 60 days ]
  • Mean change in BMI [ Time Frame: 60 days ]
  • Mean change in the score on a questionnaire for health-related quality of life [ Time Frame: 60 days ]

Estimated Enrollment: 30
Study Start Date: August 2016
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prostate Health formulation
Prostate Health formulation
Dietary Supplement: Prostate Health formulation

Detailed Description:

This study is a pilot, open-label study to evaluate the efficacy, safety and tolerability of a Prostate Health formulation. Each subject will receive a specific dose of the formulation once daily.

Participants will undergo assessments of blood tests, vital signs, body weight, BMI with completion of questionnaires.

The primary objective of the study is to assess effectiveness of the Prostate Health formulation on the I-PSS score.

Secondary objectives:

  1. To assess the I-PSS "Quality of Life" question score
  2. To assess the PSA level
  3. To assess the IIEF-5 questionnaire score
  4. To assess body weight
  5. To assess BMI
  6. To assess the score on a questionnaire for health-related quality of life
  Eligibility

Ages Eligible for Study:   45 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Primary Inclusion Criteria:

  1. Ambulatory, male, 45-75 years of age
  2. Having a BMI of 20‒35
  3. Having an I-PSS score of 1‒7
  4. Overall healthy and having no difficulty with digestion or absorption of food

Primary Exclusion Criteria:

  1. Unable to maintain stable exercise and dietary habits throughout the study
  2. History of any of the following medical condition(s): diabetes, prostate and/or bladder cancer, arrhythmia, hypotension, hypertension (unless on a stable dose of anti-hypertensive medication for 3 months prior to Baseline/screening and not likely to change medication or dose during the study period), chronic inflammatory or autoimmune disease, gastrointestinal disease (including gastroesophageal reflux and peptic ulcer), biliary obstruction (past or present), cardiovascular disease, hyper- or hypothyroidism (unless on a stable dose of medication for 3 months prior to Baseline/screening and not likely to change medication or dose during the study period), liver or kidney disease, edema with or without congestive heart failure, stroke, bleeding disorders, sleep apnea, insomnia, migraine headaches (within 3 months prior to Baseline/screening), psychiatric disorders, anxiety disorder, known or suspected estrogen-dependent neoplasia, history of thrombosis or embolism, any neurological disorder that could yield cognitive deterioration including Parkinson's disease, stroke, intracranial hemorrhage, head injury, brain tumor(s), normal pressure hydrocephalus or evidence of delirium, confusion, dementia or Alzheimer's disease, or other condition(s) that would preclude participation in the study in the judgment of the PI/Sub-Investigator (Sub-I)
  3. Having taken a 5-alpha-reductase inhibitor, alpha- or beta-blocker medication, diuretics, calcium channel blockers, tricyclic antidepressants, or anticholinergic agents 90 days prior to Baseline/screening
  4. Having taken testosterone replacement therapy for less than 3 months or unlikely to maintain the same therapeutic regimen (including dose) throughout the study period
  5. Having taken pygeum extract, beta-sitosterol, melatonin, lycopene, or boron and unwilling to discontinue use 30 days prior to enrollment (unless permitted to enroll in the judgment of the PI/Sub-I)
  6. Having taken saw palmetto, grass pollen extract, flower pollen extract, stinging and dwarf nettle extract, pumpkin seed oil extract, lignan extract, or boswellia serrata extract less than 6 months prior to screening and unwilling to discontinue use 30 days prior to enrollment (unless permitted to enroll in the judgment of the PI/Sub-I)
  7. Currently consuming a product containing olestra and unwilling to discontinue use 30 days prior to enrollment
  8. Having taken anxiolytics and sedative hypnotics, anticonvulsants, antineoplastics, anti-migraine medication(s), opioid analgesics, monoamine oxidase inhibitors (MAOIs), phosphodiesterase inhibitors, adenosine reuptake inhibitors, dopamine agonists, dopamine antagonists, or immunosuppressants within 30 days prior to Baseline/screening
  9. Having taken an anti-inflammatory medication, antihistamine or decongestant within 14 days prior to Baseline/screening
  10. Having had a surgical procedure, including prostate or bladder surgery, which would preclude study participation in the judgment of the PI/Sub-I
  11. Having any blood coagulation disorder, anemia, vitamin K deficiency, or taking anticoagulant and antiplatelet medication(s)
  12. Having abnormal screening laboratory test values: bilirubin > 2.5 x ULN, AST/SGOT and ALT/SGPT > 2.5 x ULN, serum creatinine > 1.5 mg/dL, PSA > 4 ng/mL, abnormal urinalysis (positive proteins, leukocyte, occult blood and nitrites) or any other lab test result(s) that would preclude study participation in the judgment of the PI/Sub-I
  13. Currently consumes more than 6 standard alcoholic drinks per week (a standard alcoholic drink is defined as one bottle/can of beer, one glass of wine, or one ounce of hard liquor)
  14. Unable or unwilling to abstain from consuming any alcoholic drink within two hours of taking the study product
  15. History of known alcohol or substance abuse (eg, opiates, benzodiazepines, or amphetamines)
  16. Having smoked any cigarette, electronic cigarette, cigar, pipe, or recreational drug in the past 30 days
  17. History of allergy or sensitivity to any component of the study product (as well as pine)
  18. Participation in another study within 30 days prior to Baseline/screening
  19. Unable or unwilling to avoid consuming grapefruit
  20. Having a pacemaker or any internal medical device
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02886832

Contacts
Contact: Dr. Steven Hirsh 866-517-4536 shirsh@lifeextension.com

Locations
United States, Florida
Life Extension Clinical Research, Inc. Recruiting
Fort Lauderdale, Florida, United States, 33308
Contact: Dr. Steven Hirsh    866-517-4536    shirsh@lifeextension.com   
Contact: Maria Cunningham    866-517-4536    mcunningham@lifeextension.com   
Principal Investigator: Steven Joyal, M.D.         
Sponsors and Collaborators
Supplement Formulators, Inc.
Investigators
Principal Investigator: Steven Joyal, M.D. Life Extension
  More Information

Publications:
Aguilar F, Autrup H, Barlow S et al. Scientific Opinion of the Panel onf Food Additives, Flavourings, Processing Adids and Materials in Contact with Food on a request from the Commission on the safety in use of lycopene as a food colour. The EFSA Journal. 2008;675:1-66.
Andro M, Riffaud J. Pygeum Africanum extract for the treatment of patients with benign prostatic hyperplasia: A review of 25 years of published experience. Current Therapeutic Research. 1995;56(8):796-817.
ConvertUnits.com. Convert lbs to kg - Conversion of Measurement Units. http://www.convertunits.com/from/lbs/to/kg. Copyright 2016. Accessed 6/20/2016. Cui Y, Winton M, Zhang Z et al. Dietary boron intake and prostate cancer risk. Oncology Reports. 2004;11(4):887-892.
Culver B, Hubbard S. 1996. Inorganic boron health effects in humans: An aid to risk assessment and clinical judgment. J Trace Elem Exp Med 9:175-184.
DHHS. U. S. Department of Health and Human Services. Center for Drug Evaluation and Research. Guidance for Industry. Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapetuics in Adult Heathy Volunteers. 7/2005. http://www.fda.gov/downloads/Drugs/Guidances/UCM078932.pdf. Accessed 6/21/2016.
Kava. In: Natural Medicines Comprehensive Database. Stockton, CA: Therapeutic Research Faculty. [Updated January 6, 2016; Accessed May 24, 2016]. http://naturaldatabase.therapeuticresearch.com/nd/Search.aspx?cs=OSU&s=ND&pt=100&id=872&ds =&name=KAVA&searchid=37784702
Mace, A.E. (1964), Sample Size Determination, New York: Reinhold Publishing Corporation
Risk Profile. Beta-sitosterol. CAS No. 83-46-5. http://www.mattilsynet.no/kosmetikk/stoffer_i_kosmetikk/risk_profile_betasitosterol.11370/binary/Risk%20Profile%20Beta-Sitosterol. 8/27/2012. Accessed 6/20/2016.
Stokinger HE. 1981. The halogens and nonmetals boron and silicon. In: Clayton GD, Clayton FE, eds. Patty's Industrial Hygiene and Toxicology, Vol. 2B. New York: John Wiley and Sons. Pp. 2978- 3005.

Responsible Party: Supplement Formulators, Inc.
ClinicalTrials.gov Identifier: NCT02886832     History of Changes
Other Study ID Numbers: CL089
Study First Received: August 29, 2016
Last Updated: August 31, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Supplement Formulators, Inc.:
Prostate Health

ClinicalTrials.gov processed this record on March 28, 2017