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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lycocomfort | Experimental | 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, |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lycocomfort | Dietary Supplement | 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 |
| 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 |
| 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) |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Parth Shah, MD | ObvioHealth | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Obvio Health | Orlando | Florida | 32817 | United States |
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| ID | Term |
|---|---|
| D059411 | Lower Urinary Tract Symptoms |
| ID | Term |
|---|---|
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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 |