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Diet and Erectile Dysfunction (ERECTION Trial)
N/A
Recruiting
Led By Robert Ostfeld, MD
Research Sponsored by Montefiore Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No medical therapy (other than prn MDIs (metered dose inhalers) & no change in supplements if applicable)
Male aged 18-29 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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)
Awards & highlights
ERECTION Trial Summary
This trial will study whether certain dietary patterns affect a man's ability to get and maintain an erection.
Who is the study for?
This trial is for healthy men aged 18-29 with normal erectile function, living near Montefiore Health System. Participants must have had penile-vaginal sex within the last 4 weeks and agree to dietary monitoring, abstinence from sexual activity before testing, and avoid drugs or alcohol. Excluded are those with chronic diseases, hypertension, BMI outside of 18.5-30 range, certain medical conditions or treatments.Check my eligibility
What is being tested?
The study investigates how a plant-based diet versus an animal-based diet affects erectile function in men. It involves photographing consumed food/drinks and undergoing Rigiscan™ training to measure nocturnal erections.See study design
What are the potential side effects?
There may not be direct side effects from participating in this dietary intervention; however, changes in diet can sometimes cause temporary digestive adjustments or nutritional imbalances.
ERECTION Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I only use inhalers as needed and haven't changed my supplements.
Select...
I am a man between 18 and 29 years old.
ERECTION Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 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)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percent of time ≥70% erect during overnight sleep after 4 meals.
Secondary outcome measures
Erection events per hour during overnight sleep after 4 meals.
Percent of time ≥70% erect during overnight sleep after 1 meal.
Tumescence events per hour during overnight sleep after 4 meals.
Other outcome measures
Apolipoprotein B
Asymmetric Dimethylarginine (ADMA)
Blood Pressure
+59 moreERECTION Trial Design
2Treatment groups
Active Control
Group I: Animal-based armActive Control1 Intervention
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.
Group II: Plant-based armActive Control1 Intervention
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.
Find a Location
Who is running the clinical trial?
The Purjes FoundationUNKNOWN
The Greenbaum FoundationUNKNOWN
Montefiore Medical CenterLead Sponsor
441 Previous Clinical Trials
582,150 Total Patients Enrolled
1 Trials studying Erectile Dysfunction
24 Patients Enrolled for Erectile Dysfunction
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had kidney disease or high potassium levels.I agree to not use illegal drugs, NSAIDs, or alcohol before and during the Rigiscan recording.I have a rash or lesions on or around my genital area.I am receiving treatment for low testosterone or thyroid hormone levels.You have an allergy to certain types of food.I only use inhalers as needed and haven't changed my supplements.You follow a vegetarian or vegan diet.You have a history of an eating disorder or show signs of being addicted to food.You have used illegal drugs or smoked or vaped within the past 4 weeks.I agree not to use mouthwash, spit intentionally, or brush my teeth before study visits.My BMI is 30 or higher, below 18.5, or my weight is 110lbs or less.You have taken a new experimental medication within the past month.I am a man between 18 and 29 years old.My BMI is between 18.5 and 30, and I weigh more than 110 lbs.Your sexual function score is 22 or higher on a test called IIEF.You have had problems with drugs or alcohol in the past year.I exercise for at least 15 minutes twice a week and can avoid exercising before Rigiscan measurements.You have engaged in sexual intercourse within the past 4 weeks before enrolling in the study. The score we will use to evaluate your sexual function is based on this specific time frame.I have a chronic disease that is not related to muscle/bone issues or asthma.I have high blood pressure, treated or untreated.You have engaged in sexual intercourse within the past 4 weeks. The evaluation used to measure sexual function is based on this time frame.I am currently being treated for Peyronie's Disease.I experience erectile dysfunction.I have had a cold or similar illness in the last two weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Animal-based arm
- Group 2: Plant-based arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this experiment available to individuals of an older age bracket?
"This clinical trial is only open to those between 18 and 29 years old, as per the eligibility criteria."
Answered by AI
To what degree must an individual meet the criteria to be eligible for this research?
"Eligibility criteria for this research stipulate that participants must suffer from ED and be between 18-29 years old. The experimental protocol is currently recruiting a total of 74 individuals."
Answered by AI
Is there an opportunity for volunteers to join this trial presently?
"Contrary to what is published on clinicaltrials.gov, this trial has concluded its recruitment phase. Initially posted in mid-March 2023 and last updated late October 2022, the study no longer seeks applicants; 62 other trials are still actively accepting participants though."
Answered by AI
Who else is applying?
What state do they live in?
New York
What portion of applicants met pre-screening criteria?
Met criteria
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