Effects of LycoComfort™ Supplementation on Symptoms Associated With Lower Urinary Tract Symptoms (LUTS)

NCT03772808 | Completed

• 1 other identifier: OBVIO-LYC-001
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

BPH; Lower Urinary Tract Symptoms

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Number of patients with a significant improvement in International Prostate Symptom Score (I-PSS)

  12 weeks

• Number of patients with a change in Core Lower Urinary Tract Symptom Score (CLSS)

  12 weeks

• Satisfaction from treatment evaluated by "User satisfaction questionnaire"

  12 weeks

• Adverse events (AEs)

  12 weeks

Other Outcomes (1)

• Number of patients with a change in Brief Sexual Function Index (BSFI) score

  12 weeks

Study Arms (1)

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,

Dietary Supplement: Lycocomfort

Interventions

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

Lycocomfort

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males, age 40 and older
• A score of 8 or greater on a self-administered I-PSS test

You may not qualify if:

• 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

Sponsors & Collaborators

• LycoRed Ltd.: lead

Study Sites (1)

Obvio Health

Orlando, Florida, 32817, United States

Location

MeSH Terms

Conditions

Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Parth Shah, MD

  ObvioHealth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2018
• First Posted: December 11, 2018
• Study Start: November 16, 2018
• Primary Completion: April 30, 2019
• Study Completion: June 15, 2019
• Last Updated: July 2, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)