Effects of LycoComfort™ Supplementation on Symptoms Associated With Lower Urinary Tract Symptoms (LUTS)
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|ClinicalTrials.gov Identifier: NCT03772808|
Recruitment Status : Completed
First Posted : December 11, 2018
Last Update Posted : July 2, 2019
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|
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 (Clinical Trial)|
|Actual Enrollment :||52 participants|
|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|
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
- 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).
- 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.
- 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.
- 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).
- 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
- 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)
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
|United States, Florida|
|Orlando, Florida, United States, 32817|
|Principal Investigator:||Parth Shah, MD||ObvioHealth|