Actively Recruiting
The Impact of Dietary Pattern on Erectile Function
Led by Montefiore Medical Center · Updated on 2025-11-12
46
Participants Needed
1
Research Sites
161 weeks
Total Duration
On this page
Sponsors
M
Montefiore Medical Center
Lead Sponsor
T
The Purjes Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this study is to determine whether erectile function is impacted by dietary patterns in healthy men with normal erectile function.
CONDITIONS
Official Title
The Impact of Dietary Pattern on Erectile Function
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male aged 18 to 35 years
- Provides written informed consent and HIPAA authorization in English
- Taking no medical therapy except as needed inhalers, or stable medications for anxiety, depression, or ADHD for at least 6 months
- International Index of Erectile Function (IIEF) score of 22 or higher
- Had penile sexual intercourse (vaginal or anal penetration) within 12 weeks of enrollment
- Lives within commuting distance of Montefiore Health System
- Significant other (if applicable) agrees to support the subject during the study
- Agrees to photograph and share all consumed food and drinks during dietary intervention
- Agrees to avoid illicit drugs, NSAIDs, and alcohol for at least two days prior to and during Rigiscan™ recording
- Agrees to abstain from sexual activity and erotic material for 24 hours before and during Rigiscan™ recording days
- Agrees to attend all in-person visits, begin fasting at 11pm before each visit, and undergo all testing
- Agrees not to use mouthwash or brush teeth on the morning of study visits
- Body mass index (BMI) between 18.5 and less than 30, weight over 110 lbs
- Exercises at least 15 minutes at least twice per week, maintaining similar exercise on Rigiscan™ days
- Agrees to comply with all study procedures and visits
- Agrees not to change dietary habits except during provided meal periods
You will not qualify if you...
- Relevant dietary allergy
- Vegetarian or vegan dietary pattern
- History of eating disorder or food addiction
- Hypertension or history of hypertension with blood pressure outside specified ranges at Visit 1
- BMI less than 18.5 or 30 or higher, or weight 110 lbs or less
- Known chronic medical diseases except certain non-inflammatory musculoskeletal diseases, asthma, anxiety, depression, or ADHD
- Recent or planned changes in medications for anxiety, depression, or ADHD
- Use of benzodiazepines or beta blockers
- History of kidney disease or hyperkalemia
- Erectile dysfunction
- Psychiatric illness or other conditions interfering with study adherence
- Treatment for Peyronie's Disease
- Abnormal testosterone or thyroid hormone levels
- Treated hypogonadism or hypothyroidism
- Planned travel during the study
- Transgender individuals
- Substance abuse in past 12 months
- Illicit drug use, smoking, or vaping within 4 weeks
- Upper respiratory illness within 2 weeks before screening
- Occupations requiring on-call overnight duties
- Communicable skin or venereal diseases
- Rash or lesion on penis or surrounding area
- STOP-Bang score greater than 2
- Restless Leg Syndrome diagnosis
- Insomnia defined by difficulty initiating or maintaining sleep at least 3 times per week for 1 month with daytime tiredness
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Montefiore Medical Center, Department of Medicine, Division of Cardiology
The Bronx, New York, United States, 10467
Actively Recruiting
Research Team
R
Robert Ostfeld, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
PREVENTION
Number of Arms
2
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