The Impact of a Plant-based Meat Meal Versus an Animal Meat Meal on Erectile Function in Healthy Men

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this study is to determine whether erectile function is differentially impacted by a single plant-based meat meal versus a single animal meat meal in healthy men with normal erectile function.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 32
Healthy Volunteers: t
View:

• Subject provides written informed consent and HIPAA authorization in English before any study procedures are conducted. (If the subject is a fluent Spanish and/or other language speaker, subject must also be fluent in English (understanding and speaking) to be eligible for this study.)

• IIEF score greater or equal to 22

• Subject is currently taking no medication other than prn MDIs No change in supplements if applicable

• Subject will have had penile sexual intercourse (either vaginal or anal penetration) within 12 weeks of enrollment

• Male (biological) aged 18-32 years old

• Lives within commuting distance of Montefiore Health System

• Subject's significant other (if applicable) agrees to support the subject during the study

• Subject agrees to avoid all illicit drugs, NSAIDS, and alcohol for at least two days prior to Rigiscan™ recording and on the days and nights of Rigiscan™ recording

• Subject agrees to refrain from sexual activity for at least 24 hours prior to Rigiscan™ placement and to have no sexual activity on the days and nights of Rigiscan™ recording

• Subject agrees to not view, read, or otherwise consume erotic or pornographic material for at least 24 hours prior to the days and nights of Rigiscan™ recording and on the days and nights of Rigiscan™ recording

• Subject agrees to not have an orgasm for 24 hours prior to both the days and nights of Rigiscan™ recording and on the days and nights of Rigiscan™ recording

• Subject agrees to come to Montefiore to undergo Rigiscan™ training

• Subject agrees to only consume/drink permitted food/beverages

• Subject agrees to attend all in person visits at Montefiore and to undergo all blood draws and other testing

• Subject agrees to not use mouthwash or mouth rinses or intentionally spit for the entire duration of the study. Subjects will be asked to refrain from using mouthwash for at least 2 days prior to enrollment. Subject agrees to not brush his teeth and to not use toothpaste for 24 hours preceding Rigiscan testing. Tooth brushing is otherwise permissible.

• BMI \<28.5, BMI \>=18.5, weight \>110 lbs

• Subject agrees to comply with the study procedures and visits

• Subject exercises for at least 15 minutes at least two times per week

• If exercise is done, subjects will exercise for the same amount of time and at a similar intensity each day of Rigiscan™ testing. Otherwise, no exercise will be performed on Rigiscan™ days.

• If enrolled, subjects agree to not modify their dietary habits throughout the duration of the study other than during the two evenings when food is provided.

• If enrolled, subjects agree to fast when requested to fast

Locations
United States
New York
Montefiore Medical Center
RECRUITING
The Bronx
Contact Information
Primary
Robert Ostfeld, MD, MSc
ROstfeld@Montefiore.org
718-920-5197
Time Frame
Start Date: 2024-09-19
Estimated Completion Date: 2026-10
Participants
Target number of participants: 30
Treatments
Active_comparator: Plant-based
The plant-based arm consists of consuming one plant-based meat meal and then using the Rigiscan™ device to measure the frequency, rigidity, and duration of nocturnal erections.~The meal in the plant-based arm and the meal in the animal-based arm will differ only by whether the meal contains plant-based meat or animal meat.
Active_comparator: Animal-based
The animal-based arm consists of consuming one animal meat meal and then using the Rigiscan™ device to measure the frequency, rigidity, and duration of nocturnal erections.~The meal in the plant-based arm and the meal in the animal-based arm will differ only by whether the meal contains plant-based meat or animal meat.
Related Therapeutic Areas
Sponsors
Collaborators: Beyond Meat, San Diego Sexual Medicine
Leads: Montefiore Medical Center

This content was sourced from clinicaltrials.gov