Clinical trial NCT03772808: Effects of LycoComfort™ Supplementation on Symptoms Associated With Lower Urinary Tract Symptoms (LUTS)
Official title: Effects of LycoComfort™ Supplementation on Symptoms Associated With Lower Urinary Tract Symptoms (LUTS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: BPH
Lower Urinary Tract Symptoms
Lead sponsor: LycoRed Ltd.
Sponsor class: INDUSTRY
First posted: 2018-12-11
Enrollment: 52
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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

Primary outcomes:
measure: Number of patients with a change in International Prostate Symptom Score (I-PSS)
timeFrame: Enrollment to 12 weeks
Secondary outcomes:
measure: Number of patients with a significant improvement in International Prostate Symptom Score (I-PSS)
timeFrame: 12 weeks
measure: Number of patients with a change in Core Lower Urinary Tract Symptom Score (CLSS)
timeFrame: 12 weeks
measure: Satisfaction from treatment evaluated by "User satisfaction questionnaire"
timeFrame: 12 weeks
measure: Adverse events (AEs)
timeFrame: 12 weeks
Other outcomes:
measure: Number of patients with a change in Brief Sexual Function Index (BSFI) score
timeFrame: 12 weeks
Locations:
city: Orlando
country: United States
facility: Obvio Health
state: Florida
Study officials:
affiliation: ObvioHealth
name: Parth Shah, MD
role: PRINCIPAL_INVESTIGATOR
References: