Diet and Erectile Dysfunction

(ERECTION Trial)

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

Trial Summary

What is the purpose of this trial?

The goal of this study is to determine whether erectile function is impacted by dietary patterns in healthy men with normal erectile function.

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.

What data supports the effectiveness of the treatment for erectile dysfunction?

Research suggests that a Mediterranean diet, which includes fruits, vegetables, nuts, whole grains, and olive oil, may improve erectile function in men with metabolic syndrome. Additionally, a healthy plant-based diet is associated with a decreased risk of erectile dysfunction. ^{1 2 3 4 5}

Is a plant-based diet safe for humans?

Research indicates that plant-based diets, including vegan and vegetarian diets, are generally safe for humans and may offer health benefits such as reduced risk of heart disease, obesity, and type-2 diabetes. These diets do not negatively impact erectile function in healthy men and are associated with lower mortality from ischemic heart disease. ^{2 4 6 7 8}

How does the diet treatment for erectile dysfunction differ from other treatments?

This treatment focuses on dietary changes, specifically the Mediterranean diet, which is unique because it emphasizes consuming more fruits, vegetables, nuts, whole grains, and olive oil. Unlike medications, this approach aims to improve erectile function by enhancing overall health and reducing inflammation, particularly in men with metabolic syndrome. ^{1 2 3 4 5}

Research Team

Robert Ostfeld, MD

Principal Investigator

Montefiore Medical Center

Eligibility Criteria

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

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

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

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

2. 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]

3. 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]

4. England pubmed.ncbi.nlm.nih.gov

Mediterranean diet improves erectile function in subjects with the metabolic syndrome. [2017]

5. England pubmed.ncbi.nlm.nih.gov

Dietary factors in erectile dysfunction. [2007]

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

Mortality in vegetarians and nonvegetarians: detailed findings from a collaborative analysis of 5 prospective studies. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

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

8. England pubmed.ncbi.nlm.nih.gov

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