The Impact of Dietary Pattern on Erectile Function

NCT04349059 | Recruiting

• 1 other identifier: 2019-10465
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Percent of time ≥70% erect during overnight sleep after 4 meals.

  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 4 meals.

Secondary Outcomes (3)

• Percent of time ≥70% erect during overnight sleep after 1 meal.

  During overnight sleep directly after consuming the 1 meal.

• Erection events per hour during overnight sleep after 4 meals.

  During overnight sleep directly after consuming the 4 meals.

• Tumescence events per hour during overnight sleep after 4 meals.

  During overnight sleep directly after consuming the 4 meals.

Other Outcomes (62)

• Heart rate

  Time zero (Visit 2, ~1-21 days after screen), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)

• Blood Pressure

  Time zero (Visit 2, ~1-21 days after screen), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)

• Weight

  Time zero (Visit 2, ~1-21 days after screen), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)

Study Arms (2)

Plant-based arm

ACTIVE COMPARATOR

The plant-based arm consists of 3 visits to the clinical research center, following a plant-based diet and using the Rigiscan™ device to measure the frequency, rigidity, and duration of nocturnal erections.

Other: Plant based diet

Animal-based arm

ACTIVE COMPARATOR

The animal-based arm consists of 3 visits to the clinical research center, following an animal- based diet and using the Rigiscan™ device to measure the frequency, rigidity, and duration of nocturnal erections.

Other: Animal based diet

Interventions

Animal based diet OTHER

Food will be provided by Montefiore-Einstein Food Services

Animal-based arm

Plant based diet OTHER

Food will be provided by Montefiore-Einstein Food Services

Plant-based arm

Eligibility Criteria

• Age: 18 Years - 35 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.
• 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.
• The anxiety, depression, and/or ADHD will have been controlled (per report of subject) for the last 6 months.
• 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.

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 \>=30, BMI \<18.5, or weight \<= 110lbs
• Known chronic medical disease other than non-inflammatory musculoskeletal disease, asthma, anxiety, depression, and/or ADHD.
• Subjects who have had changes in the dosage or type of their medication(s) for anxiety, depression, and/or ADHD within 3 months of enrollment.
• Subjects who have scheduled or planned medication and/or medication dose changes during the study period. These medication changes include the initiation of a new medication, discontinuation of a medication, modification of medication dose, and/or the route of administration of a medication.
• Subjects who are taking benzodiazepines and/or beta blockers
• 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

Sponsors & Collaborators

• Montefiore Medical Center: lead
• The Purjes Foundation: collaborator
• The Greenbaum Foundation: collaborator
• Nitric Oxide Innovations LLC: collaborator
• National Institutes of Health (NIH): collaborator
• Dr. Irwin Goldstein: collaborator

Study Sites (1)

Montefiore Medical Center, Department of Medicine, Division of Cardiology

The Bronx, New York, 10467, United States

RECRUITING

Related Publications (17)

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MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Diet, Plant-Based

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Robert Ostfeld, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Ostfeld, MD

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: March 27, 2020
• First Posted: April 16, 2020
• Study Start: October 30, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 12, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)