Actively Recruiting

Phase Not Applicable
Age: 18Years - 32Years
MALE
Healthy Volunteers
NCT06273592

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

Led by Montefiore Medical Center · Updated on 2026-01-23

30

Participants Needed

1

Research Sites

140 weeks

Total Duration

On this page

Sponsors

M

Montefiore Medical Center

Lead Sponsor

B

Beyond Meat

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 32Years
MALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Male (biological) aged 18-32 years old
  • IIEF score of 22 or higher
  • Currently taking no medication except as needed inhalers
  • Had penile sexual intercourse within 12 weeks before enrollment
  • Lives within commuting distance of Montefiore Health System
  • Significant other (if applicable) agrees to support the subject
  • Will avoid illicit drugs, NSAIDs, and alcohol at least two days before and during Rigiscan™ recording
  • Will refrain from sexual activity and erotic material 24 hours before and during Rigiscan™ recording
  • Will not orgasm 24 hours before and during Rigiscan™ recording
  • Will not use mouthwash or toothpaste brushing 24 hours before Rigiscan™ testing
  • BMI between 18.5 and less than 28.5; weight above 110 pounds
  • Exercises at least 15 minutes twice a week
  • Will not change dietary habits except for provided meals
  • Will fast when requested
  • Will attend all study visits and blood tests
  • Provides written informed consent and HIPAA authorization in English
Not Eligible

You will not qualify if you...

  • Allergic to relevant foods
  • Vegetarian or vegan diet
  • History of eating disorder or food addiction
  • Hypertension or abnormal blood pressure or heart rate at screening
  • BMI 28.5 or higher, below 18.5, or weight 110 pounds or less
  • Chronic medical diseases except non-inflammatory musculoskeletal disease or asthma
  • Taking benzodiazepines, stimulants, SSRIs, antidepressants, or beta blockers
  • Diagnosed or suspected obstructive sleep apnea
  • STOP-Bang score above 2
  • Diagnosis of restless leg syndrome
  • Insomnia as defined by difficulty sleeping at least 3 times per week for at least 1 month
  • History of kidney disease or high potassium
  • Received investigational drug within 30 days
  • Erectile dysfunction
  • Conditions or situations interfering with study adherence
  • Treatment for Peyronie's Disease
  • Abnormal testosterone or thyroid hormone levels
  • Treated hypogonadism or hypothyroidism
  • Planned travel during study
  • Substance abuse in last 12 months
  • Illicit drug use, smoking, or vaping within 4 weeks
  • Recent upper respiratory illness
  • On-call duties overnight during study
  • Communicable skin or venereal disease
  • Transgender status with hormone therapy or surgery
  • HIV positive
  • Rash or lesion on penis or surrounding area

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Montefiore Medical Center

The Bronx, New York, United States, 10467

Actively Recruiting

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Research Team

R

Robert Ostfeld, MD, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

PREVENTION

Number of Arms

2

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