Comparing the effects of plant-based and animal-based meals on erectile function in healthy men.

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

This study tests whether eating a plant-based meal or an animal-based meal affects erectile function in healthy men.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 32 Years
• Sex: Male
• Sponsor: Montefiore Medical Center (Academic / other)
• Locations: 1 site (The Bronx, New York)
• Trial ID: NCT06273592 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate how a single meal of plant-based meat compares to a meal of animal meat in affecting erectile function among healthy men. Participants will undergo a screening process that includes medical history, vital signs, and blood tests to ensure eligibility. Those who qualify will be randomized to receive either type of meal while maintaining their usual dietary habits otherwise. The study will measure erectile function using the International Index of Erectile Function (IIEF) and other assessments.

Who should consider this trial

Good fit: Ideal candidates are healthy men aged 18-32 with normal erectile function who live near Montefiore Health System.

Not a fit: Patients with erectile dysfunction or those outside the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into dietary impacts on erectile function, potentially guiding healthier eating choices for men.

How similar studies have performed: While dietary impacts on erectile function have been explored, this specific comparison of plant-based versus animal-based meals is relatively novel.

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* Relevant dietary allergy
* Vegetarian or Vegan dietary pattern
* History of an eating disorder and/or food addiction
* Hypertension and or history of hypertension with or without medical treatment. Systolic blood pressure \> 150mmHg and/or diastolic blood pressure \>100mmHg on Visit one. Heart rate \>99 on Visit one. Systolic blood pressure \< 85mmHg and/or diastolic blood pressure \< 50mmHg on Visit one. Heart rate \< 35 on Visit one
* BMI \>=28.5, BMI \<18.5, or weight \<= 110lbs
* Known chronic medical disease other than non-inflammatory musculoskeletal disease, asthma
* Subjects who are taking benzodiazepines, stimulants (e.g. for ADHD), SSRI, anti-depressants and/or beta blockers
* Obstructive sleep apnea (OSA) diagnosis or an ongoing evaluation for possible OSA
* Score greater than 2 on the STOP-Bang OSA screening tool
* Having the diagnosis of Restless Leg Syndrome
* Having insomnia as defined by: Subject with insomnia would have difficulty initiating or maintaining sleep (30 minutes or more at sleep initiation or 30 minutes or more to fall back asleep if wakes during the night). The above occurs at least 3 times per week for at least 1 month. Furthermore, there must be adequate opportunity for sleep and there must be associated morbidity (feels tired during the day). Definition based on: The International Classification of Sleep Disorders - Third Edition (ICSD-3), 2014
* History of kidney disease or hyperkalemia
* Subject has received an investigational drug within 30 days prior to signing consent
* Erectile dysfunction
* Has any condition (e.g., psychiatric illness) or situation that, in the investigator's opinion, may confound the study results, or may interfere significantly with the patient's ability to adhere with study procedures
* Currently undergoing treatment for Peyronie's Disease
* Abnormal Testosterone or Thyroid Stimulating Hormone level
* Treated hypogonadism or hypothyroidism
* Planned travel during the study
* History of substance abuse in the last 12 months
* Illicit drug use, smoking, or vaping within 4 weeks
* Upper respiratory illness within two weeks on screening
* If profession requires being on call, no overnight or on call duties during the study
* Subject reports any communicable skin or venereal disease
* Transgender status (Individuals who have undergone or are undergoing hormone replacement therapy or who have undergone gender affirming surgery. Individuals who plan to begin hormone replacement therapy or to undergo gender affirming surgery during the study.)
* HIV positive status via direct medical history
* Subject reports rash or lesion on the penis or surrounding area

Where this trial is running

The Bronx, New York

• Montefiore Medical Center — The Bronx, New York, United States (Recruiting)

Study contacts

• Principal investigator: Robert Ostfeld, MD, MSc — Montefiore Medical Center
• Study coordinator: Robert Ostfeld, MD, MSc

Conditions Erectile Dysfunction; Diet; Erectile function; Plant-based; Animal-based