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Effects of LycoComfort™ Supplementation on Symptoms Associated With Lower Urinary Tract Symptoms (LUTS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03772808
Recruitment Status : Completed
First Posted : December 11, 2018
Last Update Posted : July 2, 2019
Sponsor:
Information provided by (Responsible Party):
LycoRed Ltd.

Brief Summary:

This study will evaluate LycoComfort™ supplementation in alleviating symptoms associated with LUTS, BPH, and general prostate concerns.

Inflammation, oxidative stress and androgenic activity in the prostate are proven catalysts of BPH, ultimately leading to increased prostate cell proliferation. The once-daily supplement LycoComfort™, will be under investigation for symptom relief and will be taken by participants for a duration of 12 weeks.


Condition or disease Intervention/treatment Phase
BPH Lower Urinary Tract Symptoms Dietary Supplement: Lycocomfort Not Applicable

Detailed Description:

LycoComfort™ is a dietary supplement containing tomato extract and phytosterols, ingredients that have been associated with relief of symptoms associated with general prostate discomfort and Lower Urinary Tract Symptoms (LUTS).

The purpose of this study is to evaluate changes in these symptoms after taking this supplement daily for 12 weeks.

Although it was not until the latter part of the twenties century that investigators began to explore the importance of lycopene, the benefits of this natural carotenoid are well studied. A number of clinical trials have shown lycopene to be effectual for alleviating prostate discomfort, symptoms of BPH and LUTS.

The American Urological Association estimates that 90% of men between 45 and 80 years of age suffer some symptoms of LUTS. Several pathophysiological mechanisms are believed to lead to LUTS and BPH, including oxidative damage, inflammation and sympathetic nervous system issues. High blood lycopene concentrations have been suggested in epidemiological trials to be associated with decreases in oxidative stress and contributions to disease prevention overall. Also, clinical trials have shown that higher levels of lycopene in the blood are associated with a reduced risk of prostate cancer, as well as other inflammatory conditions.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effects of LycoComfort™ Supplementation on Symptoms Associated With Lower Urinary Tract Symptoms (LUTS)
Actual Study Start Date : November 16, 2018
Actual Primary Completion Date : April 30, 2019
Actual Study Completion Date : June 15, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lycocomfort
The once-daily supplement LycoComfort™ is a combination of lycopene and beta-sitosterol, a chemically defined extract of phytosterols with beta-sitosterol as the main component,
Dietary Supplement: Lycocomfort
Evaluate of the perceived efficacy of LycoComfort™ supplements in alleviating symptoms associated with lower urinary tract symptoms (LUTS) and general prostate discomfort over the duration of 12 weeks intervention




Primary Outcome Measures :
  1. Number of patients with a change in International Prostate Symptom Score (I-PSS) [ Time Frame: Enrollment to 12 weeks ]
    Change from enrollment to week 12 in prostate symptoms, measured by the Prostate Symptom Score questionnaire (I-PSS) ranged 1-35 points (1-7: Mild 8-19: Moderate 20-35: Severe).


Secondary Outcome Measures :
  1. Number of patients with a significant improvement in International Prostate Symptom Score (I-PSS) [ Time Frame: 12 weeks ]
    The number of subjects with a clinically significant improvement in International Prostate Symptom Score (I-PSS) at week 12, defined as an improvement of at least 3 points in a 1-35 point scale.

  2. Number of patients with a change in Core Lower Urinary Tract Symptom Score (CLSS) [ Time Frame: 12 weeks ]
    Change from enrollment to week 12 in urinary symptoms, measured by Core Lower Urinary Tract Symptom Score (CLSS), ranged 1-31 points.

  3. Satisfaction from treatment evaluated by "User satisfaction questionnaire" [ Time Frame: 12 weeks ]
    Subject satisfaction with the LycoComfort™ supplement, as derived from responses to "User satisfaction Questionnaire" ( 5 point Likert scale, ranged 8-45 points).

  4. Adverse events (AEs) [ Time Frame: 12 weeks ]
    Adverse events (AEs) reported during the treatment period and classified by the Investigator as to intensity, relationship to study procedures, and seriousness


Other Outcome Measures:
  1. Number of patients with a change in Brief Sexual Function Index (BSFI) score [ Time Frame: 12 weeks ]
    Change from enrollment to week 12 in sexual function, measured by Brief Sexual Function Index (BSFI) score ( ranged 0-44 points)



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males, age 40 and older
  • A score of 8 or greater on a self-administered I-PSS test

Exclusion Criteria:

  • Acute or chronic prostatitis
  • Acute urinary retention
  • Allergy or sensitivity to any of the test product components (tomato [lycopene] or beta-sitosterol)
  • Cancer of the prostate (PCa) or other cancers, current or a history of PCa
  • Chronic diseases of the kidneys and/or liver
  • Hematuria of unknown etiology
  • Infection or malfunction of the urinary tract
  • Inflammatory diseases of the urogenital tract
  • Medication, herbal supplementation or other substance use for the treatment of urinary symptoms, BPH/LUTS, or erectile dysfunction, including medications which may affect hormonal status within 30 days before screening. These may include, but are not limited to: Sildenafil/Viagra; Tadalafil/Cialis; Vardenafil/Levitra; "Herbal Viagra"; Alpha-Blockers; Oral Steroids, Spironolactone or Testosterone
  • Previous radiotherapy of prostate
  • Previous surgery of the prostate, bladder or urethra

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03772808


Locations
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United States, Florida
Obvio Health
Orlando, Florida, United States, 32817
Sponsors and Collaborators
LycoRed Ltd.
Investigators
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Principal Investigator: Parth Shah, MD ObvioHealth
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Responsible Party: LycoRed Ltd.
ClinicalTrials.gov Identifier: NCT03772808    
Other Study ID Numbers: OBVIO-LYC-001
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lower Urinary Tract Symptoms
Urological Manifestations