Diet and Erectile Dysfunction
(ERECTION Trial)
Recruiting in Palo Alto (17 mi)
Overseen byRobert Ostfeld, MD
Age: 18 - 65
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
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
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?
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.24678
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.12345
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.
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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
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Trial 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 (Other)
- Plant based diet (Other)
Trial OverviewThe 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
2Treatment groups
Active Control
Group I: Animal-based armActive Control1 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 armActive Control1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Montefiore Medical Center, Department of Medicine, Division of CardiologyBronx, NY
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Who Is Running the Clinical Trial?
Montefiore Medical CenterLead Sponsor
The Purjes FoundationCollaborator
The Greenbaum FoundationCollaborator
References
The association of popular diets and erectile function among men in the United States. [2021]To determine the relationship between popular diets and erectile function we queried the National Health and Nutrition Examination Survey, a cross-sectional dataset, between 2001 and 2004. All men aged 18-85 who answered the prostate and dietary questionnaires were included. Diets were categorized as Mediterranean, low-fat, low-carbohydrate, or nonrestrictive. Multivariable models were created to determine the relationship between erectile function and each diet. Among 4027 men, 649 (16.1%) met criteria for a low-fat diet, 1085 (26.9%) for a Mediterranean diet, and 0 (0%) for a low-carbohydrate diet. 1999 men (49.6%) had some degree of erectile dysfunction. Men with nonrestrictive diets were more likely to endorse normal erectile function compared with those adhering to the Mediterranean or low-fat diets (both p
The association between plant-based diet and erectile function in Chinese young healthy men: A population-based study. [2021]The study was designed and conducted to evaluate the plant-based diet status and its association with erectile function (EF) in Chinese young healthy men. From July 2018 to May 2020, 116 objectively proved physically and psychologically healthy men were selected. Clinical questionnaires, detailed physical examinations and blood tests were all assessed. An overall plant-based diet index (PDI) and a healthful plant-based diet index (hPDI) were developed from each participant to measure plant-based diet quantitatively. The EF was measured by both the International Index of Erectile Function-5 (IIEF-5) and the surrogated measures of endothelial function, peripheral levels of nitric oxide (NO) and E-selectin. In subjects, the mean PDI and hPDI were 53.8 ± 8.2 and 54.7 ± 8.9 respectively. Results of multivariate analysis showed that both PDI and hPDI were negatively associated with BMI (all p .05). In a subgroup of male population, Chinese young healthy men, the plant-based diet, measured by PDI and hPDI, was not related to erectile function. The population can adhere to plant-based diet to keep healthy without concerns of negative influence on erectile function.
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]To investigate the association between the plant-based content of diet and erectile dysfunction in men from the National Health and Nutrition Examination Survey (NHANES).
Mediterranean diet improves erectile function in subjects with the metabolic syndrome. [2017]Men with the metabolic syndrome demonstrate an increased prevalence of erectile dysfunction (ED). In the present study, we tested the effect of a Mediterranean-style diet on ED in men with the metabolic syndrome. Men were identified in our database of subjects participating in controlled trials evaluating the effect of lifestyle changes and were included if they had a diagnosis of ED associated with a diagnosis of metabolic syndrome, complete follow-up in the study trial, and intervention focused mainly on dietary changes. Sixty-five men with the metabolic syndrome met the inclusion/exclusion criteria; 35 out of them were assigned to the Mediterranean-style diet and 30 to the control diet. After 2 years, men on the Mediterranean diet consumed more fruits, vegetables, nuts, whole grain, and olive oil as compared with men on the control diet. Endothelial function score and inflammatory markers (C-reactive protein) improved in the intervention group, but remained stable in the control group. There were 13 men in the intervention group and two in the control group (P=0.015) that reported an IIEF score of 22 or higher. Mediterranean-style diet rich in whole grain, fruits, vegetables, legumes, walnut, and olive oil might be effective per se in reducing the prevalence of ED in men with the metabolic syndrome.
Dietary factors in erectile dysfunction. [2007]The role of dietary factors in erectile dysfunction (ED) has never been addressed. In the present case-control study, we investigated the relation of the Mediterranean diet with ED. A total of 100 men with ED were compared with 100 age-matched men without ED. A scale indicating the degree of adherence to the Mediterranean diet was constructed: the total Mediterranean diet score ranged from 0 (minimal adherence to the Mediterranean diet) to 9 (maximal adherence). The percentage of physical inactivity was greater in the ED group (35 vs 19%, P=0.04), whereas the diet score was lower (4.7+/-0.5 vs 5.4+/-0.5, P
Mortality in vegetarians and nonvegetarians: detailed findings from a collaborative analysis of 5 prospective studies. [2022]We combined data from 5 prospective studies to compare the death rates from common diseases of vegetarians with those of nonvegetarians with similar lifestyles. A summary of these results was reported previously; we report here more details of the findings. Data for 76172 men and women were available. Vegetarians were those who did not eat any meat or fish (n = 27808). Death rate ratios at ages 16-89 y were calculated by Poisson regression and all results were adjusted for age, sex, and smoking status. A random-effects model was used to calculate pooled estimates of effect for all studies combined. There were 8330 deaths after a mean of 10.6 y of follow-up. Mortality from ischemic heart disease was 24% lower in vegetarians than in nonvegetarians (death rate ratio: 0.76; 95% CI: 0.62, 0.94; P5 y. Further categorization of diets showed that, in comparison with regular meat eaters, mortality from ischemic heart disease was 20% lower in occasional meat eaters, 34% lower in people who ate fish but not meat, 34% lower in lactoovovegetarians, and 26% lower in vegans. There were no significant differences between vegetarians and nonvegetarians in mortality from cerebrovascular disease, stomach cancer, colorectal cancer, lung cancer, breast cancer, prostate cancer, or all other causes combined.
Beyond meatless, the health effects of vegan diets: findings from the Adventist cohorts. [2022]Vegetarians, those who avoid meat, and vegans, additionally avoiding dairy and eggs, represent 5% and 2%, respectively, of the US population. The aim of this review is to assess the effects of vegetarian diets, particularly strict vegetarian diets (i.e., vegans) on health and disease outcomes. We summarized available evidence from three prospective cohorts of Adventists in North America: Adventist Mortality Study, Adventist Health Study, and Adventist Health Study-2. Non-vegetarian diets were compared to vegetarian dietary patterns (i.e., vegan and lacto-ovo-vegetarian) on selected health outcomes. Vegetarian diets confer protection against cardiovascular diseases, cardiometabolic risk factors, some cancers and total mortality. Compared to lacto-ovo-vegetarian diets, vegan diets seem to offer additional protection for obesity, hypertension, type-2 diabetes, and cardiovascular mortality. Males experience greater health benefits than females. Limited prospective data is available on vegetarian diets and body weight change. Large randomized intervention trials on the effects of vegetarian diet patterns on neurological and cognitive functions, obesity, diabetes, and other cardiovascular outcomes are warranted to make meaningful recommendations.
Plant-based diet index and erectile dysfunction in the Health Professionals Follow-Up Study. [2023]To evaluate the longitudinal association between plant-based diet index (PDI) score and incident erectile dysfunction (ED).