A Randomized Triple-Blind Placebo-Controlled Study to Evaluate the Effects of a Supplement on Lower Urinary Tract Symptoms in Men.

NCT06504472 | Completed

• 1 other identifier: 20405
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effects of the ProstaThrive™ supplement on lower urinary tract symptoms (LUTS) in men. It is a 90-day virtual, randomized, placebo-controlled trial with 80 male participants aged 40 and above. The primary endpoint is the reduction in LUTS, while secondary endpoints include changes in sexual function and performance.

Conditions

Lower Urinary Tract Symptoms; Benign Prostatic Hyperplasia; Erectile Dysfunction

Keywords

Pumpkin Seed Extract; Lycopene; Stinging Nettle; Beta-Sitosterols

Outcome Measures

Primary Outcomes (1)

• Change in Lower Urinary Tract Symptoms (LUTS)

  Measured by urinary urgency, nighttime urination frequency (nocturia), perceived urinary flow, and perceived bladder emptying at Baseline, Day 30, Day 60, and Day 90 via questionnaires, including questions adapted from the International Prostate Symptom Score (IPSS).

  Baseline, Day 30, Day 60, and Day 90

Secondary Outcomes (1)

• Change in Sexual Function and Performance

  Baseline, Day 30, Day 60, and Day 90

Study Arms (2)

Intervention (ProstaThrive™)

EXPERIMENTAL

Participants will take three capsules daily after the final meal of the day for 90 days.

Dietary Supplement: ProstaThrive™ Supplement

Placebo

PLACEBO COMPARATOR

Participants will take three placebo capsules daily after the final meal of the day for 90 days.

Dietary Supplement: Placebo

Interventions

ProstaThrive™ Supplement DIETARY_SUPPLEMENT

Participants in this arm will take three ProstaThrive™ capsules daily after the final meal of the day for 90 days.

Intervention (ProstaThrive™)

Placebo DIETARY_SUPPLEMENT

Participants in this arm will take three placebo capsules daily after the final meal of the day for 90 days. The placebo capsules will contain an inert substance that mimics the appearance of the ProstaThrive™ supplement.

Placebo

Eligibility Criteria

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

You may qualify if:

• Male participants aged 40+
• Experience symptoms such as frequent nighttime urination, incomplete bladder emptying, weak urinary stream, and frequent daytime urination
• Difficulty in getting or maintaining an erection
• Willing to avoid introducing any new products or medications targeting LUTS or erectile dysfunction during the study period

You may not qualify if:

• Recent surgeries or invasive treatments
• History of prostate or male reproductive cancers
• Urinary issues caused by neurological conditions
• Previous surgery on the genitals, prostate, bladder, or urethra
• Known allergies to product ingredients
• Diagnosed with chronic health conditions impacting study participation
• Current substance abuse
• Participation in other clinical trials
• Taking medications or supplements targeting LUTS or erectile dysfunction

Sponsors & Collaborators

• Optimale: lead
• Citruslabs: collaborator

Study Sites (1)

Citruslabs

Santa Monica, California, 90404, United States

Location

MeSH Terms

Conditions

Lower Urinary Tract Symptoms; Prostatic Hyperplasia; Erectile Dysfunction

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Triple (Participant, Investigator, Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 16, 2024
• Study Start: February 7, 2024
• Primary Completion: June 24, 2024
• Study Completion: June 24, 2024
• Last Updated: July 16, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)