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Behavioural Intervention

Plant-Based vs Animal Meat for Erectile Dysfunction (ERECTION 2 Trial)

N/A

Recruiting

Led By Robert Ostfeld, MD, MSc

Research Sponsored by Montefiore Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject provides written informed consent and HIPAA authorization in English before any study procedures are conducted. If the subject is a fluent Spanish and/or other language speaker, subject must also be fluent in English (understanding and speaking) to be eligible for this study.

Male (biological) aged 18-32 years old

Must not have

Having the diagnosis of Restless Leg Syndrome

Known chronic medical disease other than non-inflammatory musculoskeletal disease, asthma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during overnight sleep directly after consuming the 1 meal. up to 7 months.

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to investigate if eating plant-based meat or animal meat affects erectile function in healthy men with normal erectile function.

Who is the study for?

This trial is for healthy, biologically male individuals aged 18-32 who have had sexual intercourse in the last 12 weeks and have normal erectile function (IIEF score ≥22). Participants must not be on medication except for as-needed inhalers, avoid erotic material, drugs, NSAIDs, alcohol before and during Rigiscan recording sessions. They should live near Montefiore Health System and have support from their partner.

What is being tested?

The study aims to compare the effects of a single meal on erectile function: one group will consume a plant-based meat meal while the other will eat an animal meat meal. The impact on participants with normal erectile health will be measured using Rigiscan technology.

What are the potential side effects?

Since this trial involves consumption of regular meals (plant-based or animal-based), there are no direct side effects associated with typical food intake expected. However, individual reactions to different types of foods can vary.

Eligibility Criteria

Inclusion Criteria

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

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I understand and speak English well and have given my consent in writing.

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I am a biological male between 18 and 32 years old.

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I am only using as-needed inhalers and haven't changed my supplements.

Exclusion Criteria

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

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I have been diagnosed with Restless Leg Syndrome.

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I have a chronic illness, but it's not related to muscle/bone issues or asthma.

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I experience erectile dysfunction.

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I am receiving treatment for low testosterone or thyroid levels.

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I have a rash or lesion on or around my penis.

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I have trouble sleeping or staying asleep at least 3 nights a week for over a month.

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I am currently being treated for Peyronie's Disease.

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I have a communicable skin or sexually transmitted disease.

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I am currently taking medication for anxiety, ADHD, depression, or heart issues.

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I have had kidney disease or high potassium levels.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during overnight sleep directly after consuming the 1 meal. up to 7 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during overnight sleep directly after consuming the 1 meal. up to 7 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and during overnight sleep directly after consuming the 1 meal. up to 7 months. 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 with ≥70% erection during overnight sleep after 1 meal

Secondary study objectives

Erection events per hour during overnight sleep after 1 meal

Tumescence events per hour during overnight sleep after 1 meal.

Other study objectives

Blood pressure

Heart rate

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: Plant-basedActive Control1 Intervention

The plant-based arm consists of consuming one plant-based meat meal and then using the Rigiscan™ device to measure the frequency, rigidity, and duration of nocturnal erections. The meal in the plant-based arm and the meal in the animal-based arm will differ only by whether the meal contains plant-based meat or animal meat.

Group II: Animal-basedActive Control1 Intervention

The animal-based arm consists of consuming one animal meat meal and then using the Rigiscan™ device to measure the frequency, rigidity, and duration of nocturnal erections. The meal in the plant-based arm and the meal in the animal-based arm will differ only by whether the meal contains plant-based meat or animal meat.

0 / 13Eligibility criteria met