Plant-Based vs Animal Meat for Erectile Dysfunction

(ERECTION 2 Trial)

Overseen by Robert Ostfeld, MD, MSc

Age: 18 - 65

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Montefiore Medical Center

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

Disqualifiers: Hypertension, Obstructive sleep apnea, Insomnia, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The goal of this study is to determine whether erectile function is differentially impacted by a single plant-based meat meal versus a single animal meat meal in healthy men with normal 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.

What data supports the effectiveness of a plant-based diet treatment for erectile dysfunction?

Research suggests that diets rich in vegetables, fruits, nuts, legumes, and fish, similar to a plant-based diet, may benefit erectile function by improving metabolism and reducing red meat intake. Additionally, plant-based diets have shown health benefits for conditions like cardiovascular diseases, which are related to erectile dysfunction. ^{1 2 3 4 5}

Is it safe to follow a plant-based or animal-based diet for health conditions?

Plant-based diets, including vegetarian and vegan diets, are generally safe and associated with health benefits such as reduced risk of heart disease, obesity, and type 2 diabetes. They are nutritionally adequate if well-planned, though attention should be paid to nutrients like iron and vitamin B12. Animal-based diets are also safe but may not offer the same level of protection against certain diseases as plant-based diets. ^{2 5 6 7 8}

How does the plant-based vs animal meat treatment for erectile dysfunction differ from other treatments?

This treatment is unique because it explores the impact of dietary choices, specifically plant-based versus animal-based meals, on erectile dysfunction, rather than using medications or surgical interventions. It focuses on the potential benefits of a plant-based diet, which may improve erectile function by promoting better overall health and metabolism, as suggested by studies linking such diets to improved vascular health. ^{1 3 9 10 11}

Research Team

Robert Ostfeld, MD, MSc

Principal Investigator

Montefiore Medical Center

Eligibility Criteria

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.

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

Exclusion Criteria

I have been diagnosed with Restless Leg Syndrome.

Relevant dietary allergy

Vegetarian or Vegan dietary pattern

Trial Timeline

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

Treatment Details

Interventions

• Animal-based Meal (Behavioural Intervention)
• Plant-based Meat Meal (Behavioural Intervention)

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.

Participant Groups

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+

Andrew D. Racine

Montefiore Medical Center

Chief Medical Officer since 1992

MD, PhD from New York University; Undergraduate degree from Harvard University

Philip O. Ozuah

Montefiore Medical Center

Chief Executive Officer since 2019

MD, PhD from New York University

Beyond Meat

Collaborator

Trials

1

Recruited

30+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

The association between plant-based diet and erectile function in Chinese young healthy men: A population-based study. [2021]

2. Spain pubmed.ncbi.nlm.nih.gov

[Vegetarian diets; effect on health]. [2019]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Relationship between Dietary Patterns with Benign Prostatic Hyperplasia and Erectile Dysfunction: A Collaborative Review. [2021]

4. United States 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. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

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

6. England pubmed.ncbi.nlm.nih.gov

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

7. United States pubmed.ncbi.nlm.nih.gov

Diet quality of vegetarian diets compared with nonvegetarian diets: a systematic review. [2020]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Cardio-Metabolic Benefits of Plant-Based Diets. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Plant-based diet index and erectile dysfunction in the Health Professionals Follow-Up Study. [2023]

10. England pubmed.ncbi.nlm.nih.gov

The association of popular diets and erectile function among men in the United States. [2021]

11. United States 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. [2022]