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One Plant-Based meal may boost nighttime erections, small study hints

NCT ID NCT06273592

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares how a single plant-based meat meal (a Beyond Meat product) versus an animal meat meal affects erectile function in 30 healthy men with normal erections. Participants eat one meal and then wear a Rigiscan device overnight to measure erection hardness and frequency. The goal is to see if the plant-based meal leads to better erectile function than the meat meal.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
plant-based meat meal (Beyond Meat product) and animal-based meat meal
What this could lead to
If it works, this could suggest that even one plant-based meal may help erectile function, pointing toward dietary changes as a simple aid.
What could go wrong
This is a very small, early study in healthy men, not those with erectile dysfunction. It tests only a single meal, so any effect may be tiny or not last.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 32 years

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Montefiore Medical Center

    RECRUITING

    The Bronx, New York, 10467, United States

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