A Study to Evaluate the Effects of a Prostate Health Formulation

April 16, 2018 updated by: Supplement Formulators, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Life Extension Clinical Research, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prostate Health formulation
Dietary supplement: Prostate Health formulation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Supplement Formulators, Inc.

Investigators

  • Principal Investigator: Steven Joyal, M.D., Life Extension

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2016

Primary Completion (Actual)

February 27, 2018

Study Completion (Actual)

March 27, 2018

Study Registration Dates

First Submitted

August 29, 2016

First Submitted That Met QC Criteria

August 31, 2016

First Posted (Estimate)

September 1, 2016

Study Record Updates

Last Update Posted (Actual)

April 18, 2018

Last Update Submitted That Met QC Criteria

April 16, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CL089

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prostate Health

Clinical Trials on Prostate Health formulation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritius

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe