46 Participants Needed

Diet and Erectile Dysfunction

(ERECTION Trial)

RO
Overseen ByRobert Ostfeld, MD
Age: 18 - 65
Sex: Male
Trial Phase: Academic
Sponsor: Montefiore Medical Center
Must be taking: SSRIs, SNRIs, Stimulants
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

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.12345

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.23678

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.23678

Who Is on the Research Team?

RO

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

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.
See 17 more

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
See 16 more

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?
2Treatment groups
Active Control
Group I: Animal-based armActive Control1 Intervention
Group II: Plant-based armActive Control1 Intervention

Find a Clinic Near You

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+

Published Research Related to This Trial

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.
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.
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.
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]

Citations

The association of popular diets and erectile function among men in the United States. [2021]
The association between plant-based diet and erectile function in Chinese young healthy men: A population-based study. [2021]
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]
Mediterranean diet improves erectile function in subjects with the metabolic syndrome. [2017]
Dietary factors in erectile dysfunction. [2007]
Mortality in vegetarians and nonvegetarians: detailed findings from a collaborative analysis of 5 prospective studies. [2022]
Beyond meatless, the health effects of vegan diets: findings from the Adventist cohorts. [2022]
Plant-based diet index and erectile dysfunction in the Health Professionals Follow-Up Study. [2023]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security