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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

Must not have

History of kidney disease or hyperkalemia

Any communicable skin or venereal disease. Subject reports rash or lesions on the penis or surrounding area. Subject will be asked, 'do you have a rash or lesion on your penis or surrounding area?'

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

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I only use inhalers as needed and haven't changed my supplements.

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I am a man between 18 and 29 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had kidney disease or high potassium levels.

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I have a rash or lesions on or around my genital area.

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I am receiving treatment for low testosterone or thyroid hormone levels.

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I have a chronic disease that is not related to muscle/bone issues or asthma.

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I have high blood pressure, treated or untreated.

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I am currently being treated for Peyronie's Disease.

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I experience erectile dysfunction.

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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 study objectives

Apolipoprotein B

Asymmetric Dimethylarginine (ADMA)

Blood Pressure

+59 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 9Eligibility criteria met