The Impact of a Plant-Based Diet Versus an Animal-Based Diet on Erectile Function in Healthy Men With Normal Erectile Function: The ERECTION Study
The goal of this study is to determine whether erectile function is impacted by dietary patterns in healthy men with normal erectile function.
• Subject provides written informed consent and HIPAA authorization in English before any study procedures are conducted.
• Subject is taking no medical therapy other than: prn MDIs, medication(s) for anxiety, depression, and/or ADHD (these medications include, but are not limited to, SSRIs, SNRIs, Stimulants), no change in supplements if applicable.
⁃ The anxiety, depression, and/or ADHD will have been controlled (per report of subject) for the last 6 months.
• IIEF score greater or equal to 22
• Subject will have had penile-sexual intercourse (either vaginal or anal penetration) within 12 weeks of enrollment.
• Male aged 18-35 years old
• Lives within commuting distance of Montefiore Health System
• Subject's significant other (if applicable) agrees to support the subject during the study
• Subject agrees to photograph and share all items consumed/drunk during the dietary intervention
• Subject agrees to avoid all illicit drugs, NSAIDS, and alcohol for at least two days prior to Rigiscan™ recording and on the days and nights of Rigiscan™ recording
• Subject agrees to refrain from sexual activity for at least 24 hours prior to Rigiscan™ placement and to have no sexual activity on the days and nights of Rigiscan™ recording.
• Subject agrees to not view, read, or otherwise consume erotic or pornographic material for 24 hours prior to both the days and nights of Rigiscan™ recording and on the days and nights of Rigiscan™ recording.
• Subject agrees to not have an orgasm for 24 hours prior to both the days and nights of RigiscanTM recording and on the days and nights of Rigiscan™ recording.
• Subject agrees to come to Montefiore to undergo Rigiscan™ training
• Subject agrees to only consume/drink permitted food/beverages.
• Subject agrees to attend all in person visits at Montefiore, to begin fasting at 11pm the night before each visit, and to undergo all blood draws/salivary/other testing.
• Subject agrees to not use mouthwash or mouth rinses or intentionally spit for the entire duration of the study. Subjects will be asked to refrain from using mouthwash for at least 2 days prior to enrollment. Subject agrees to not brush his teeth in the morning of the day of each study visit. Tooth brushing is otherwise permissible.
• BMI \<30, BMI \>=18.5, weight \>110 lbs.
• Subject agrees to comply with the study procedures and visits.
• Subject exercises for at least 15 minutes at least two times per week
• If exercise is done, subjects will exercise for the same amount of time and at a similar intensity each day of Rigiscan™ testing. Otherwise, no exercise will be performed on Rigiscan™ days.
• If enrolled, subjects agree to not modify their dietary habits throughout the duration of the study other than during the two evenings and two full days when food is provided.