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

Not Applicable

Completed

• Conditions: Erectile Dysfunction; Benign Prostatic Hyperplasia; Lower Urinary Tract Symptoms
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: ProstaThrive™ Supplement

• Registration Number: NCT06504472
• Lead Sponsor: Optimale

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.

Detailed Description

This is a virtual two-arm randomized placebo-controlled clinical trial lasting 90 days. Participants will take the ProstaThrive™ supplement or a placebo daily and complete questionnaires at Baseline, Day 30, Day 60, and Day 90. The study will assess the efficacy of ProstaThrive™ on LUTS such as urinary urgency, nighttime urination frequency, perceived urinary flow, and bladder emptying, as well as secondary outcomes related to sexual function.

Study Timeline

• Study Start: 2024-02-07
• Primary Completion: 2024-06-24
• Study Completion: 2024-06-24
• Status Verified: 2024-07
• Study First Submitted: 2024-07-11
• Study First Submitted QC: 2024-07-11
• Last Update Submitted: 2024-07-11
• Study First Posted: 2024-07-16
• Last Update Posted: 2024-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 80

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants will take three placebo capsules daily after the final meal of the day for 90 days.
Intervention (ProstaThrive™)	ProstaThrive™ Supplement	Participants will take three capsules daily after the final meal of the day for 90 days.

Primary Outcome Measures

Name	Time	Method
Change in Lower Urinary Tract Symptoms (LUTS)	Baseline, Day 30, Day 60, and Day 90	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).

Secondary Outcome Measures

Name	Time	Method
Change in Sexual Function and Performance	Baseline, Day 30, Day 60, and Day 90	Measured by the ability to get and maintain an erection at Baseline, Day 30, Day 60, and Day 90 via study-specific questionnaires.

Trial Locations

Locations (1)

Citruslabs; 🇺🇸 Santa Monica, California, United States