BPHNCT03772808
Effects of LycoComfort™ Supplementation on Symptoms Associated With Lower Urinary Tract Symptoms (LUTS)
A study testing Lycocomfort in people with BPH and Lower Urinary Tract Symptoms, run by LycoRed Ltd. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- BPH, Lower Urinary Tract Symptoms
- What is being tested?
- Lycocomfort
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2018to 15 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males, age 40 and older
- A score of 8 or greater on a self-administered I-PSS test
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- BPH, Lower Urinary Tract Symptoms
- Being tested
- Lycocomfort
- Medical subject headings
- Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LycocomfortDietary 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
| Study group | Role | What they receive |
|---|---|---|
| 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, Receives: Dietary Supplement: Lycocomfort |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Enrollment to 12 weeks
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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).
Measured: 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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2018
- Study start16 Nov 2018
- Primary completion30 Apr 2019
- Study completion15 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BPHStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- LycoRed Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Parth Shah, MD, Principal investigator, ObvioHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03772808
- Sponsor's protocol ID
- OBVIO-LYC-001
- Status last verified
- Jun 2019
- First submitted
- 19 Nov 2018
- Last updated
- 2 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of LycoComfort™ Supplementation on Symptoms Associated With Lower Urinary Tract Symptoms (LUTS)
- ClinicalTrials.gov ID
- NCT03772808
- Acronym / sponsor ID
- OBVIO-LYC-001
- Conditions
- BPH, Lower Urinary Tract Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- LycoRed Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Nov 2018 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 15 Jun 2019 (actual)
- First posted
- 11 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lycocomfort | Experimental | Dietary Supplement: LycocomfortThe 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, |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Males, age 40 and older
- A score of 8 or greater on a self-administered I-PSS test
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LycocomfortEvaluate 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 | Dietary supplement | Lycocomfort |
Primary outcome
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).
4 secondary outcomes
Number of patients with a significant improvement in International Prostate Symptom Score (I-PSS)
Time frame: 12 weeks
Number of patients with a change in Core Lower Urinary Tract Symptom Score (CLSS)
Time frame: 12 weeks
Satisfaction from treatment evaluated by "User satisfaction questionnaire"
Time frame: 12 weeks
Adverse events (AEs)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Parth Shah, MD principal investigator
ObvioHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lycocomfort in people with BPH and Lower Urinary Tract Symptoms, run by LycoRed Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with a change in International Prostate Symptom Score (I-PSS) (time frame: Enrollment to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2019.