The Impact of Dietary Pattern on Erectile Function

Description

The goal of this study is to determine whether erectile function is impacted by dietary patterns in healthy men with normal erectile function.

Conditions

Erectile Dysfunction

Study Overview

Study Details

Study overview

The goal of this study is to determine whether erectile function is impacted by dietary patterns in healthy men with normal erectile function.

The Impact of a Plant-Based Diet Versus an Animal-Based Diet on Erectile Function in Healthy Men With Normal Erectile Function: The ERECTION Study

The Impact of Dietary Pattern on Erectile Function

Condition
Erectile Dysfunction
Intervention / Treatment

-

Contacts and Locations

Bronx

Montefiore Medical Center, Department of Medicine, Division of Cardiology, Bronx, New York, United States, 10467

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.
  • * 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.

Ages Eligible for Study

18 Years to 35 Years

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Montefiore Medical Center,

Robert Ostfeld, MD, PRINCIPAL_INVESTIGATOR, Montefiore Medical Center

Study Record Dates

2025-12