Diet and Erectile Dysfunction

(ERECTION Trial)

Recruiting at 1 trial location

Overseen By Robert Ostfeld, MD

Age: 18 - 65

Sex: Male

Trial Phase: Academic

Sponsor: Montefiore Medical Center

Must be taking: SSRIs, SNRIs, Stimulants

Must not be taking: Benzodiazepines, Beta blockers

Disqualifiers: Hypertension, Eating disorder, Kidney disease, others

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

Compensation: Varies

Number of Visits: 7

46 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how different diets might affect erectile function in healthy men. Participants will follow either an animal-based or plant-based diet and use a device called Rigiscan™ to track nocturnal erections. Men who have had recent sexual activity, live near Montefiore Health System, and can follow specific dietary guidelines may be a good fit. The trial is for those without conditions like high blood pressure or erectile dysfunction.

As an unphased trial, this study offers participants the opportunity to contribute to groundbreaking research on diet and sexual health.

Will I have to stop taking my current medications?

The trial allows participants to continue taking medications for anxiety, depression, and ADHD, as long as there have been no changes in dosage or type in the last 3 months and no changes are planned during the study. Other medications may not be allowed, but the protocol does not specify further details.

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

Research has shown that both plant-based and animal-based diets are generally safe for most people. Studies suggest that plant-based diets might lower the risk of erectile dysfunction and improve sexual health, as they include fruits, vegetables, grains, and nuts, which are linked to better blood flow and reduced erectile dysfunction.

For animal-based diets, clear evidence about their effect on erectile function is limited. However, diets rich in fruits and nuts, such as the Mediterranean diet, are often considered beneficial for health.

Both types of diets are widely followed without serious side effects, making them safe. Consulting a healthcare provider for personalized advice is always recommended, especially if there are specific health concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the dietary approach to managing erectile dysfunction because it offers a non-pharmaceutical option that could have fewer side effects. Unlike standard treatments like Viagra, which focus on increasing blood flow through medication, this study looks at how different diets—specifically animal-based and plant-based diets—might impact erectile function. The unique feature here is the potential for diet to improve overall vascular health, which could naturally enhance erectile function. This approach not only targets the symptoms but might also address underlying health factors, providing a holistic path to improvement.

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

This trial will compare the effects of an animal-based diet with a plant-based diet on erectile function. Research has shown that plant-based diets might improve erectile function. Studies have found that men who primarily consume plant-based foods tend to experience better erections, likely because these diets enhance blood vessel function, which is crucial for erections. A national database also found that men who consume more plant-based foods are less likely to experience erectile dysfunction.

In contrast, while some research suggests that diets high in animal products can affect erectile function, the evidence remains less compelling. Diets rich in fruits, vegetables, and nuts, which are more plant-based, consistently show benefits for erectile health. Overall, plant-based diets seem to offer more promise for improving erectile function. Participants in this trial will be assigned to either the animal-based arm or the plant-based arm to evaluate these effects. ^{1 5 6 7 8}

Who Is on the Research Team?

Robert Ostfeld, MD

Principal Investigator

Montefiore Medical Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I agree to not use illegal drugs, NSAIDs, or alcohol before and during the Rigiscan recording.

Subject's significant other (if applicable) agrees to support the subject during the study

Subject agrees to refrain from sexual activity for at least 36 hours prior to Rigiscan™ placement and to have no sexual activity on the days and nights of Rigiscan™ recording

Exclusion Criteria

I have had kidney disease or high potassium levels.

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

If profession requires being on call, no overnight or on call duties during the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-21 days

1 visit (in-person)

Treatment - Plant-Based Diet

Participants follow a plant-based diet with Rigiscan™ assessments and dietary monitoring

3 days

3 visits (in-person)

Washout

Participants return to their usual dietary habits during an 8-12 day washout period

8-12 days

Treatment - Animal-Based Diet

Participants follow an animal-based diet with Rigiscan™ assessments and dietary monitoring

3 days

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Animal based diet
• Plant based diet

Trial Overview 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.

How Is the Trial Designed?

Group I: Animal-based arm Active Control 1 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 arm Active Control 1 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.

Who Is Running the Clinical Trial?

Montefiore Medical Center

Lead Sponsor

Trials

468

Recruited

599,000+

The Purjes Foundation

Collaborator

Trials

1

Recruited

50+

The Greenbaum Foundation

Collaborator

Trials

1

Recruited

50+

Nitric Oxide Innovations LLC

Industry Sponsor

Trials

1

Recruited

520+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Dr. Irwin Goldstein

Collaborator

Published Research Related to This Trial

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 76,172 participants over an average follow-up of 10.6 years, vegetarians had a 24% lower mortality rate from ischemic heart disease compared to nonvegetarians, particularly among those who had maintained their vegetarian diet for over 5 years.

While vegetarians showed lower mortality rates from ischemic heart disease, there were no significant differences in mortality rates from other major diseases such as cancer or cerebrovascular disease when compared to nonvegetarians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mortality in vegetarians and nonvegetarians: detailed findings from a collaborative analysis of 5 prospective studies. Key, TJ., Fraser, GE., Thorogood, M., 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]

A Mediterranean-style diet significantly improved erectile dysfunction (ED) in men with metabolic syndrome, with 13 men in the diet group reporting improved scores compared to only 2 in the control group after 2 years.

The diet led to better endothelial function and reduced inflammation, suggesting that dietary changes can have a positive impact on both sexual health and overall cardiovascular health in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mediterranean diet improves erectile function in subjects with the metabolic syndrome. Esposito, K., Ciotola, M., Giugliano, F., et al.[2017]

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]

A case-control study involving 200 men (100 with erectile dysfunction and 100 without) found that those with ED had lower adherence to the Mediterranean diet, scoring an average of 4.7 compared to 5.4 for those without ED.

The study suggests that dietary factors, particularly the intake of fruits, nuts, and healthy fats, may play a significant role in the development of erectile dysfunction, indicating that adopting a healthier diet could help prevent this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary factors in erectile dysfunction. Esposito, K., Giugliano, F., De Sio, M., et al.[2007]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11949448/

Association between improved erectile function and dietary ... Our meta-analysis underscores a strong dietary-ED association, suggesting that low-fat/Mediterranean diets rich in produce and nuts could benefit ED management.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022316625002299

Critical Review Plant-Based Diet and Erectile Dysfunction A plant-based diet focused on whole plant foods could enhance penile erection as it improves endothelial function through various mechanisms.

3. withpower.com withpower.com/trial/phase-erectile-dysfunction-3-2024-b2edc

Plant-Based vs Animal Meat 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7666422/

Association of Diet With Erectile Dysfunction Among Men in ... This cohort study examines the association of adherence to Mediterranean or Alternative Healthy Eating Index 2010 diets with incidence of erectile dysfunction ...

5. news-medical.net news-medical.net/news/20250625/Plant-based-diets-may-help-prevent-erectile-dysfunction.aspx

Plant-based diets may help prevent erectile dysfunction Review suggests that choosing whole plant foods over processed or animal-based options could lower the risk of erectile dysfunction.

6. sciencedirect.com sciencedirect.com/science/article/pii/S2050116122000137

Evaluating the Effects of Low Carbohydrate and High ... The results based on this animal model indicate that extreme carbohydrate restricted diet may affect erectile function. Our study identified that LCHP ...

7. jn.nutrition.org jn.nutrition.org/article/S0022-3166(25)00229-9/fulltext

Plant-Based Diet and Erectile Dysfunction: A Narrative Review A plant-based diet focused on whole plant foods could enhance penile erection as it improves endothelial function through various mechanisms.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05632367

Relationship Between Nutrition and Sexual Activity Studies evaluating the relationship between diet and erectile dysfunction have focused more on men with diabetes. Some small studies have also shown that ...