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

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.

Study Overview

• Status: Completed
• Conditions: Lower Urinary Tract Symptoms; BPH
• Intervention / Treatment: Dietary supplement: Lycocomfort

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32817
      • Obvio Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with a change in International Prostate Symptom Score (I-PSS)	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).	Enrollment to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with a significant improvement in International Prostate Symptom Score (I-PSS)	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.	12 weeks
Number of patients with a change in Core Lower Urinary Tract Symptom Score (CLSS)	Change from enrollment to week 12 in urinary symptoms, measured by Core Lower Urinary Tract Symptom Score (CLSS), ranged 1-31 points.	12 weeks
Satisfaction from treatment evaluated by "User satisfaction questionnaire"	Subject satisfaction with the LycoComfort™ supplement, as derived from responses to "User satisfaction Questionnaire" ( 5 point Likert scale, ranged 8-45 points).	12 weeks
Adverse events (AEs)	Adverse events (AEs) reported during the treatment period and classified by the Investigator as to intensity, relationship to study procedures, and seriousness	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with a change in Brief Sexual Function Index (BSFI) score	Change from enrollment to week 12 in sexual function, measured by Brief Sexual Function Index (BSFI) score ( ranged 0-44 points)	12 weeks

Collaborators and Investigators

• Sponsor: LycoRed Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2018
• Primary Completion (Actual): April 30, 2019
• Study Completion (Actual): June 15, 2019

Study Registration Dates

• First Submitted: November 19, 2018
• First Submitted That Met QC Criteria: December 9, 2018
• First Posted (Actual): December 11, 2018

Study Record Updates

• Last Update Posted (Actual): July 2, 2019
• Last Update Submitted That Met QC Criteria: June 30, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urological Manifestations; Lower Urinary Tract Symptoms
• Other Study ID Numbers: OBVIO-LYC-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No