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Prostate HealthNCT02886832

A Study to Evaluate the Effects of a Prostate Health Formulation

A study testing Prostate Health formulation in people with Prostate Health, run by Supplement Formulators, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 45 to 75 years, men onlyHealthy volunteers can take part
Conditions the study is for
Prostate Health
What is being tested?
Prostate Health formulation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
21 Sep 2016to 27 Mar 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 75 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Life Extension Clinical Research, Inc.

    Fort Lauderdale, Florida, 33308

Other trials in United States

About this study

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

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.

Read the 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
Conditions
Prostate Health
Being tested
Prostate Health formulation
Keywords
Prostate Health

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prostate Health formulationDietary supplement

Study groups in NCT02886832
Study groupRoleWhat they receive
Prostate Health formulationExperimentalProstate Health formulation
Receives: Dietary Supplement: Prostate Health formulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean change on I-PSS score

    Measured: 60 days

Secondary outcomes (6)

  1. Mean change on the I-PSS Quality of Life question score

    Measured: 60 days

  2. Mean change in the PSA level

    Measured: 60 days

  3. Mean change on the IIEF-5 questionnaire score

    Measured: 60 days

  4. Mean change in body weight

    Measured: 60 days

  5. Mean change in BMI

    Measured: 60 days

  6. Mean change in the score on a questionnaire for health-related quality of life

    Measured: 60 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2016 (estimated)
  2. Study start21 Sep 2016
  3. Primary completion27 Feb 2018
  4. Study completion27 Mar 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02886832
Sponsor's protocol ID
CL089
Status last verified
Apr 2018
First submitted
29 Aug 2016
Last updated
18 Apr 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Adjakly M, Ngollo M, Dagdemir A, Judes G, Pajon A, Karsli-Ceppioglu S, Penault-Llorca F, Boiteux JP, Bignon YJ, Guy L, Bernard-Gallon D. Prostate cancer: The main risk and protective factors-Epigenetic modifications. Ann Endocrinol (Paris). 2015 Feb;76(1):25-41. doi: 10.1016/j.ando.2014.09.001. Epub 2015 Jan 13.

    PubMed 25592466

  • 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.

  • Andersen LP, Gogenur I, Rosenberg J, Reiter RJ. The Safety of Melatonin in Humans. Clin Drug Investig. 2016 Mar;36(3):169-75. doi: 10.1007/s40261-015-0368-5.

    PubMed 26692007

  • 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.

  • Ansari MS, Gupta NP. Lycopene: a novel drug therapy in hormone refractory metastatic prostate cancer. Urol Oncol. 2004 Sep-Oct;22(5):415-20. doi: 10.1016/j.urolonc.2004.05.009.

    PubMed 15464923

  • Assar EA, Vidalle MC, Chopra M, Hafizi S. Lycopene acts through inhibition of IkappaB kinase to suppress NF-kappaB signaling in human prostate and breast cancer cells. Tumour Biol. 2016 Jul;37(7):9375-85. doi: 10.1007/s13277-016-4798-3. Epub 2016 Jan 16.

    PubMed 26779636

  • Awad AB, Chen YC, Fink CS, Hennessey T. beta-Sitosterol inhibits HT-29 human colon cancer cell growth and alters membrane lipids. Anticancer Res. 1996 Sep-Oct;16(5A):2797-804.

    PubMed 8917388

  • Awad AB, Chinnam M, Fink CS, Bradford PG. beta-Sitosterol activates Fas signaling in human breast cancer cells. Phytomedicine. 2007 Nov;14(11):747-54. doi: 10.1016/j.phymed.2007.01.003. Epub 2007 Mar 12.

    PubMed 17350814

  • Awad AB, Gan Y, Fink CS. Effect of beta-sitosterol, a plant sterol, on growth, protein phosphatase 2A, and phospholipase D in LNCaP cells. Nutr Cancer. 2000;36(1):74-8. doi: 10.1207/S15327914NC3601_11.

    PubMed 10798219

  • Awad AB, Roy R, Fink CS. Beta-sitosterol, a plant sterol, induces apoptosis and activates key caspases in MDA-MB-231 human breast cancer cells. Oncol Rep. 2003 Mar-Apr;10(2):497-500.

    PubMed 12579296

  • Azimi H, Khakshur AA, Aghdasi I, Fallah-Tafti M, Abdollahi M. A review of animal and human studies for management of benign prostatic hyperplasia with natural products: perspective of new pharmacological agents. Inflamm Allergy Drug Targets. 2012 Jun;11(3):207-21. doi: 10.2174/187152812800392715.

    PubMed 22512478

  • Barlet A, Albrecht J, Aubert A, Fischer M, Grof F, Grothuesmann HG, Masson JC, Mazeman E, Mermon R, Reichelt H, et al. [Efficacy of Pygeum africanum extract in the medical therapy of urination disorders due to benign prostatic hyperplasia: evaluation of objective and subjective parameters. A placebo-controlled double-blind multicenter study]. Wien Klin Wochenschr. 1990 Nov 23;102(22):667-73. German.

    PubMed 1702916

  • Barranco WT, Eckhert CD. Boric acid inhibits human prostate cancer cell proliferation. Cancer Lett. 2004 Dec 8;216(1):21-9. doi: 10.1016/j.canlet.2004.06.001.

    PubMed 15500945

  • Barranco WT, Eckhert CD. Cellular changes in boric acid-treated DU-145 prostate cancer cells. Br J Cancer. 2006 Mar 27;94(6):884-90. doi: 10.1038/sj.bjc.6603009.

    PubMed 16495920

  • Barry MJ, Fowler FJ Jr, O'Leary MP, Bruskewitz RC, Holtgrewe HL, Mebust WK, Cockett AT. The American Urological Association symptom index for benign prostatic hyperplasia. The Measurement Committee of the American Urological Association. J Urol. 1992 Nov;148(5):1549-57; discussion 1564. doi: 10.1016/s0022-5347(17)36966-5.

    PubMed 1279218

Questions about this trial

What is this clinical trial studying?

A study testing Prostate Health formulation in people with Prostate Health, run by Supplement Formulators, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean change on I-PSS score (time frame: 60 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02886832, which also lists 80 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2018.

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