Plant-Based vs Animal Meat for Erectile Dysfunction

(ERECTION 2 Trial)

Recruiting at 1 trial location

Overseen By Robert Ostfeld, MD, MSc

Age: 18 - 65

Sex: Male

Trial Phase: Academic

Sponsor: Montefiore Medical Center

Must not be taking: Benzodiazepines, Stimulants, SSRIs, Beta blockers

Disqualifiers: Hypertension, Obstructive sleep apnea, Insomnia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a plant-based meal or an animal-based meal affects erectile function differently in healthy men. Participants will consume one type of meal, after which their nocturnal erections (nighttime erections) will be measured. Men in good health, with normal erectile function, and recent penile sexual intercourse may be suitable for this study. As an unphased trial, it offers participants the chance to contribute to understanding dietary impacts on erectile function.

Do I need to stop taking my current medications for the trial?

Yes, you must not be taking any medications other than as-needed inhalers to participate in this trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that plant-based diets can benefit sexual health. People who consume more fruits, vegetables, and nuts are less likely to experience erectile dysfunction. Studies have not identified any major safety issues with plant-based meals, which are usually easy to digest and linked to better overall health.

In contrast, consuming more animal meat might increase the risk of erectile problems. Some studies suggest that people who eat more animal meat may face a higher chance of these issues. However, no specific safety concerns exist about eating a single meal with animal meat.

In summary, both types of meals are generally safe for most people, but plant-based meals might offer some benefits for sexual health. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about this trial because it explores the potential link between diet and erectile dysfunction, examining whether plant-based meats might affect the condition differently than animal meats. Unlike typical treatments for erectile dysfunction, which often involve medications like Viagra or Cialis, this trial investigates dietary changes as a natural intervention. By using meals instead of pills, the study aims to uncover whether eating plant-based or animal-based meals can make a difference in nocturnal erection quality, potentially offering a non-pharmaceutical approach to managing the condition.

What evidence suggests that this trial's treatments could be effective for erectile dysfunction?

This trial will compare the effects of plant-based meals with animal-based meals on erectile function. Research suggests that plant-based diets might improve erectile function. Some studies have shown that consuming more plant-based foods links to a lower risk and less severe erectile dysfunction (ED). These diets may enhance blood flow, crucial for erections. Conversely, consuming more animal-based foods has been associated with a higher risk of ED. Men who ate more plant-based foods and fewer animal-based foods generally exhibited better erectile health. While the evidence isn't definitive yet, these findings suggest that plant-based meals could benefit erectile function. ^{1 2 5 6 7}

Who Is on the Research Team?

Robert Ostfeld, MD, MSc

Principal Investigator

Montefiore Medical Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have had sexual intercourse in the last 12 weeks.

I agree not to use mouthwash or spit intentionally during the study.

Subject agrees to not view, read, or otherwise consume erotic or pornographic material for at least 24 hours prior to the days and nights of Rigiscan™ recording and on the days and nights of Rigiscan™ recording

Exclusion Criteria

I have been diagnosed with Restless Leg Syndrome.

Relevant dietary allergy

Vegetarian or Vegan dietary pattern

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 visit

1 visit (in-person)

Treatment - Sequence One

Participants consume a plant-based meal and undergo Rigiscan™ assessment overnight

1 day

2 visits (in-person)

Washout Period

Participants return to their usual dietary habits for a washout period

5-8 days

Treatment - Sequence Two

Participants consume an animal-based meal and undergo Rigiscan™ assessment overnight

1 day

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 7 months

What Are the Treatments Tested in This Trial?

Interventions

• Animal-based Meal
• Plant-based Meat Meal

Trial Overview

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.

How Is the Trial Designed?

Group I: Plant-based Active Control 1 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-based Active Control 1 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.

Who Is Running the Clinical Trial?

Montefiore Medical Center

Lead Sponsor

Trials

468

Recruited

599,000+

Beyond Meat

Collaborator

Trials

1

Recruited

30+

San Diego Sexual Medicine

Collaborator

Trials

5

Recruited

130+

Published Research Related to This Trial

Vegetarian diets, particularly those of lacto-ovo vegetarians and vegans, were found to have significantly higher diet quality scores (4.5-16.4 points higher on the Healthy Eating Index 2010) compared to nonvegetarian diets in 9 out of 12 studies reviewed.

The improved diet quality in vegetarians was mainly due to better adherence to recommendations for fruits, whole grains, seafood, and plant proteins, while nonvegetarians showed better adherence to refined grains and total protein foods, suggesting that diet quality may contribute to the health benefits associated with vegetarian diets.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet quality of vegetarian diets compared with nonvegetarian diets: a systematic review. Parker, HW., Vadiveloo, MK.[2020]

In a study of 4027 men aged 18-85, no specific diet (Mediterranean, low-fat, or nonrestrictive) was found to significantly impact erectile function, suggesting that diet alone may not be a determining factor for erectile health.

Men with nonrestrictive diets reported better erectile function compared to those on Mediterranean or low-fat diets, but after adjusting for factors like age and health conditions, no significant differences were observed among the diet groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The association of popular diets and erectile function among men in the United States. Fantus, RJ., Halpern, JA., Chang, C., et al.[2021]

Plant-based diets, including vegetarian and vegan options, can significantly reduce the risk of cardio-metabolic diseases, with estimates showing a 40% reduction in coronary heart disease events and a 29% reduction in stroke events.

These diets are not only effective for improving nutrient intake but also help in weight management and glycemic control, potentially reversing atherosclerosis and lowering blood pressure, making them a recommended strategy for preventing and treating cardio-metabolic diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardio-Metabolic Benefits of Plant-Based Diets. Kahleova, H., Levin, S., Barnard, N.[2022]

A 10-week low-fat, plant-based diet led to significant reductions in body fat percentage (4.3% points) and weight (5.6 kg) among 241 participants, compared to 84 control subjects who received nutrition lectures.

Participants on the plant-based diet maintained muscle mass while increasing the percentage of muscle mass, indicating that this diet can effectively reduce fat without compromising muscle health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of an Ad Libitum Consumed Low-Fat Plant-Based Diet Supplemented with Plant-Based Meal Replacements on Body Composition Indices. Jakše, B., Pinter, S., Jakše, B., et al.[2022]

Vegetarian diets, especially vegan diets, are associated with lower risks of cardiovascular diseases, obesity, hypertension, type-2 diabetes, and certain cancers, based on evidence from three large cohorts of Adventists in North America.

Males tend to experience greater health benefits from vegetarian diets compared to females, but more extensive randomized trials are needed to fully understand the impact of these diets on various health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beyond meatless, the health effects of vegan diets: findings from the Adventist cohorts. Le, LT., Sabaté, J.[2022]

In a study of 116 healthy young Chinese men, a plant-based diet was found to have no negative impact on erectile function, as measured by the International Index of Erectile Function-5 (IIEF-5).

The study indicated that while plant-based diet indices were negatively associated with body mass index (BMI), they did not correlate with levels of nitric oxide, E-selectin, or erectile function scores, suggesting that men can maintain a plant-based diet without worrying about adverse effects on erectile health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The association between plant-based diet and erectile function in Chinese young healthy men: A population-based study. Lu, Y., Tian, J., Wang, S., et al.[2021]

A review of literature from 1964 to September 2021 indicates that dietary patterns, particularly adherence to the Mediterranean diet, may positively influence erectile dysfunction (ED) and benign prostatic hyperplasia (BPH) by promoting the intake of vegetables, fruits, nuts, legumes, and fish while reducing red meat consumption.

The beneficial effects of a healthy diet on ED and BPH may stem from its impact on prostatic growth and smooth muscle tone, suggesting that dietary changes could improve symptoms, although further research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship between Dietary Patterns with Benign Prostatic Hyperplasia and Erectile Dysfunction: A Collaborative Review. Russo, GI., Broggi, G., Cocci, A., et al.[2021]

In a study of 21,942 men aged 40 to 75, a higher score on the healthy plant-based diet index (hPDI) was linked to an 18% lower risk of developing erectile dysfunction (ED) in men aged 60 to <70 years.

Conversely, a higher score on the unhealthy plant-based diet index (uPDI) was associated with a greater risk of ED in men under 60, suggesting that dietary choices can significantly impact erectile function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Plant-based diet index and erectile dysfunction in the Health Professionals Follow-Up Study. Yang, H., Breyer, BN., Rimm, EB., et al.[2023]

Plant-based diets can provide similar energy and protein levels as meat-containing diets, supporting normal growth and development.

However, these diets may lack essential nutrients like iron and vitamin B12, highlighting the importance of careful planning to ensure nutritional adequacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The nutritional adequacy of plant-based diets. Sanders, TA.[2019]

A well-planned vegetarian diet, which includes vegetables, eggs, and milk, is considered healthy and nutritionally adequate, offering health benefits in preventing and treating various diseases.

Research suggests that vegetarian diets may help reduce the risk of obesity, cancer, hypertension, and type 2 diabetes, although more studies are needed to confirm benefits for conditions like Parkinson's disease and rheumatoid arthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Vegetarian diets; effect on health]. de Luis Román, D., Aller, R., Castaño, O.[2019]

In a study of 2549 men, a healthful plant-based diet was found to be negatively associated with erectile dysfunction, suggesting that higher consumption of plant-based foods may reduce the risk of ED (OR = 0.98).

No significant association was found between overall plant-based diet index (PDI) and erectile dysfunction, indicating that the quality of plant-based foods consumed (as measured by the healthful plant-based diet index, hPDI) is more important than the quantity alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consumption of a Healthy Plant-based Diet is Associated With a Decreased Risk of Erectile Dysfunction: A Cross-sectional Study of the National Health and Nutrition Examination Survey. Carto, C., Pagalavan, M., Nackeeran, S., et al.[2022]

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