A Study to Evaluate the Effects of a Prostate Health Formulation

Study Overview
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Brief Summary
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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.

Detailed Description
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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: To assess the I-PSS Quality of Life question score To assess the PSA level To assess the IIEF-5 questionnaire score To assess body weight To assess BMI To assess the score on a questionnaire for health-related quality of life

Official Title
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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

Conditions
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Prostate Health

Intervention / Treatment
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* Dietary Supplement: Prostate Health formulation


Participation Criteria
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Eligibility Criteria
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Primary Inclusion Criteria: Ambulatory, male, 45-75 years of age Having a BMI of 20-35 Having an I-PSS score of 1-7 Overall healthy and having no difficulty with digestion or absorption of food Primary Exclusion Criteria: Unable to maintain stable exercise and dietary habits throughout the study 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) 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 Having taken testosterone replacement therapy for less than 3 months or unlikely to maintain the same therapeutic regimen (including dose) throughout the study period 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) 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) Currently consuming a product containing olestra and unwilling to discontinue use 30 days prior to enrollment 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 Having taken an anti-inflammatory medication, antihistamine or decongestant within 14 days prior to Baseline/screening Having had a surgical procedure, including prostate or bladder surgery, which would preclude study participation in the judgment of the PI/Sub-I Having any blood coagulation disorder, anemia, vitamin K deficiency, or taking anticoagulant and antiplatelet medication(s) 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 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) Unable or unwilling to abstain from consuming any alcoholic drink within two hours of taking the study product History of known alcohol or substance abuse (eg, opiates, benzodiazepines, or amphetamines) Having smoked any cigarette, electronic cigarette, cigar, pipe, or recreational drug in the past 30 days History of allergy or sensitivity to any component of the study product (as well as pine) Participation in another study within 30 days prior to Baseline/screening Unable or unwilling to avoid consuming grapefruit Having a pacemaker or any internal medical device

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prostate Health formulation<br>Prostate Health formulation | Dietary Supplement: Prostate Health formulation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change on I-PSS score |  | 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change on the I-PSS Quality of Life question score |  | 60 days | 
| Mean change in the PSA level |  | 60 days | 
| Mean change on the IIEF-5 questionnaire score |  | 60 days | 
| Mean change in body weight |  | 60 days | 
| Mean change in BMI |  | 60 days | 
| Mean change in the score on a questionnaire for health-related quality of life |  | 60 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate Health