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

NCT06273592 | Recruiting

• 1 other identifier: 2023-15558
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Erectile Dysfunction

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Percent of time with ≥70% erection during overnight sleep after 1 meal

  Total time (in minutes) when penile rigidity is ≥70% at both the tip and the base of the penis as measured by Rigiscan™ during overnight sleep, divided by the total time (in minutes) of overnight sleep. Overnight sleep is defined as the time in minutes from the onset of the first nocturnal erection to the end of the last nocturnal erection (as measured by Rigiscan™).

  During overnight sleep directly after consuming the 1 meal. Up to 7 months.

Secondary Outcomes (2)

• Erection events per hour during overnight sleep after 1 meal

  During overnight sleep directly after consuming the 1 meal. Up to 7 months.

• Tumescence events per hour during overnight sleep after 1 meal.

  During overnight sleep directly after consuming the 1 meal. Up to 7 months.

Other Outcomes (2)

• Heart rate

  Pre and post overnight Rigiscan recording. Up to 7 months.

• Blood pressure

  Pre and post overnight Rigiscan recording. Up to 7 months.

Study Arms (2)

Plant-based

ACTIVE COMPARATOR

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.

Other: Plant-based meat meal

Animal-based

ACTIVE COMPARATOR

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.

Other: Animal-based meal

Interventions

Animal-based meal OTHER

Consuming a single plant-based meat or a single animal meat meal and measuring the meals impact on erectile function with the Rigiscan™ device.

Also known as: Animal-based meal will be provided by Montefiore-Einstein Food Services

Animal-based

Plant-based meat meal OTHER

Consuming a single plant-based meat or a single animal meat meal and measuring the meals impact on erectile function with the Rigiscan™ device.

Also known as: A Beyond Meat product will be used as the plant-based meat and will be provided by Montefiore-Einstein Food Services

Plant-based

Eligibility Criteria

• Age: 18 Years - 32 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Montefiore Medical Center: lead
• Beyond Meat: collaborator
• San Diego Sexual Medicine: collaborator

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

RECRUITING

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Robert Ostfeld, MD, MSc

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Ostfeld, MD, MSc

CONTACT

718-920-5197; ROstfeld@Montefiore.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor will be blinded to randomization group and order of testing.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized crossover design

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 22, 2024
• Study Start: September 19, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)