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Dietary Patterns and Erectile Function Study

This study aims to understand if different eating patterns affect erectile function in healthy men. Researchers will provide participants with either an animal-based diet or a plant-based diet. The main goal is to see how much time participants spend with at least 60% erection during overnight Rigiscan™ (a device that measures erections during sleep) use after eating four meals on their assigned diet. You may be able to join if you are a man between 18 and 35 years old and have normal erectile function. The study is looking to enroll 46 participants. The study status is currently unclear, so it's not known if they are actively recruiting.

Study design
This is an interventional study, meaning participants will receive a specific intervention (either an animal-based or plant-based diet). It plans to enroll 46 men.
What's involved
You will undergo a screening visit including questionnaires, medical history, physical measurements, and blood tests. If eligible, you will be randomized to one of two diet groups and will have food provided. You will also use a Rigiscan™ device for overnight measurements.
Compensation
Not stated in the trial record.
Follow-up
Erectile function will be measured during overnight Rigiscan™ use directly after consuming the four meals, specifically on the second night of Rigiscan™ use.

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NCT04349059

The Impact of Dietary Pattern on Erectile Function

Recruiting
NAAges 18–35InterventionalPrevention
Montefiore Medical Center
~46 participants
Updated 2026-07-24 on ClinicalTrials.gov
What's tested:Animal based dietPlant based diet

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent of time ≥60% erect during overnight Rigiscan™ use after 4 meals.
Measured over During overnight Rigiscan™ use directly after consuming the 4 meals. (The second night of Rigiscan™ use).

Conditions

Erectile Dysfunction

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Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Robert Ostfeld, MD · PRINCIPAL_INVESTIGATOR · Montefiore Medical Center

Who to contact

Robert Ostfeld, MD
[email protected]
718-920-5197
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Subject provides written informed consent and HIPAA authorization in English before any study procedures are conducted.
Subject is taking no medical therapy other than: prn MDIs, medication(s) for anxiety, depression, and/or ADHD (these medications include, but are not limited to, SSRIs, SNRIs, Stimulants), no change in supplements if applicable.
IIEF score greater or equal to 22
Subject will have had penile-sexual intercourse (either vaginal or anal penetration) within 12 weeks of enrollment.
Male aged 18-35 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 photograph and share all items consumed/drunk during the dietary intervention
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 24 hours prior to both 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 RigiscanTM 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, to begin fasting at 11pm the night before each visit, and to undergo all blood draws/salivary/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 in the morning of the day of each study visit. Tooth brushing is otherwise permissible.
BMI \<30, 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 and two full days when food is provided.

Exclusion

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 \>=30, BMI \<18.5, or weight \<= 110lbs
Known chronic medical disease other than non-inflammatory musculoskeletal disease, asthma, anxiety, depression, and/or ADHD.
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
The subject is trans-gender
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
Subject reports rash or lesion on the penis or surrounding area.
STOP-Bang score \> 2
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.

What this trial measures

  • Percent of time ≥60% erect during overnight Rigiscan™ use after 4 meals.During overnight Rigiscan™ use directly after consuming the 4 meals. (The second night of Rigiscan™ use).

    The first 5 minutes of Rigiscan™ recording is discarded. Erection time is the total time (in minutes) when penile rigidity is ≥ 60% at both the tip and base of the penis with a concurrent increase in penile tumescence at both the tip and base of the penis compared to baseline tumescence as measured by Rigiscan™ during overnight Rigiscan™ use, divided by the total time (in minutes) of overnight Rigiscan™ use. Overnight Rigiscan™ use time is defined as starting 5 minutes after the start of the Rigiscan™ recording and the end of Rigiscan™ use is defined as the last time the tip or base was \>=10% rigid with a corresponding concurrent increase in penile tumescence at the tip or base compared to baseline tumesence. This total time window from start to end is the Rigiscan™ use time.