Effects of LycoComfort™ Supplementation on Symptoms Associated With Lower Urinary Tract Symptoms (LUTS)
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Other Indications |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 40 - Any |
| Updated: | 2/28/2019 |
| Start Date: | November 16, 2018 |
| End Date: | May 30, 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.
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.
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.
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
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