The Impact of Dietary Pattern on Erectile Function

Summary

Participation Requirements

Description

Subject's significant other (if applicable) will support the subject during the study Subject will photograph and share all items consumed/drunk during the dietary intervention Subject will avoid all illicit drugs, NSAIDS, and alcohol for at least two days prior to Rigiscan™ recording and on the day...

Subject's significant other (if applicable) will support the subject during the study Subject will photograph and share all items consumed/drunk during the dietary intervention Subject will 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 will have no 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 will avoid exercise the day before and days of RigiscanTM Subject will not view, read, or otherwise consume erotic or pornographic material for at least 36 hours prior to the days and nights of Rigiscan™ recording and on the days and nights of Rigiscan™ recording Subject will come to Montefiore to undergo Rigiscan™ training Subject will only consume/drink permitted food/beverages. Subject will attend all in person meetings at Montefiore, to have been fasting (other than water) since 11pm before each and agree to all blood draws/salivary/other testing. Subject will not use mouthwash or mouth rinses or intentionally spit for the entire duration of the study. The investigators will advise no mouthwash use for at least 2 days prior to enrollment. Tooth brushing, other than the morning before study visits, is permitted. Visit 1: After reviewing and signing consent, subjects will be screened. Screening will consist of: Complete IIEF and a food-frequency questionnaire. Record medical history, medications Measure height and weight Vitals Draw blood for total testosterone and TSH Examine genitals for rash or lesions If the IIEF score is abnormal, subjects will be advised to contact their primary care provider. Subjects will be contacted with their Testosterone and TSH. If abnormal subject will be advised to contact their PCP. If the subject has no PCP, contact information for a PCP will be given. Subjects meeting inclusion and exclusion criteria will be randomized into either sequence one or sequence two. Once enrolled, subjects will 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 (see below). Sequence One: Visit 2: Subjects return to the study center in the morning after having fasted (other than consuming water) since 11pm the night before. They will not brush their teeth or use mouthwash and/or other breath fresheners that morning. Anthropomorphic, blood pressure, and EndoPATTM recordings will be made. Saliva will be stored. Blood will be drawn and stored. Subjects will be taught how to use the RigiscanTM device. Subjects will receive one plant-based dinner. Subjects will then leave the study center and they will consume their usual diet until 5pm. For the rest of the evening until 11pm they will consume only the dinner provided. Water will be the only beverage allowed after 5pm. Dinner should be consumed at 8:30pm, EST. Subjects will text pictures of everything they consume (eat or drink) after 5pm to Dr. Ostfeld or to a study representative and s/he will have text or verbal contact with the subject at least once that evening. That night, subjects will do a Rigiscan™ assessment overnight at their home. The time the subject goes to bed and the time the subject wakes up for the day should be recorded. The subject agrees to be in bed with Rigiscan™ on (other than for emergency or needed trips to the bathroom) for at least seven hours. Visit 3 Subjects return to the study center the morning after the Rigiscan™ assessment and bring the Rigiscan™ device. They will have been fasting other than drinking water since 11pm the night before. They will not brush their teeth or use mouthwash and/or other breath fresheners that morning. Anthropomorphic, blood pressure, and EndoPATTM recordings will be made. Saliva will be stored. Blood will be drawn and stored. Subjects will then receive one full day of plant-based meals. Subjects will be encouraged to eat breakfast at the study center after the initial anthropomorphic measures are made, saliva is obtained, and blood is drawn. Subjects will text pictures of all they consume during that day to Dr. Ostfeld and/or to a study representative and s/he will have text or verbal contact with the subject at least twice during that day. Dinner should be consumed at 8:30pm, EST. Subjects will fast other than water after 11pm. That night, subjects will do a Rigiscan™ assessment overnight at their home. Black coffee and/or tea is permitted only before noon. The time the subject goes to bed and the time the subject wakes up for the day should be recorded. The subject agrees to be in bed with Rigiscan™ on (other than for emergency or needed trips to the bathroom) for at least seven hours. Visit 4 Subjects return to the study center the morning after the Rigiscan™ assessment and bring the Rigiscan™ device. They will have not brush their teeth or use mouthwash and/or other breath fresheners that morning. Anthropomorphic, blood pressure, and EndoPATTM recordings will be made. Saliva will be stored. Blood will be drawn and stored. There will then be a washout period for 8-12 days and subjects will be instructed to return to their usual dietary habits during this washout period. Visit 5 After the washout period, subjects return to the study center in the morning after having fasted (other than consuming water) since 11pm the night before. They will have not brush their teeth or use mouthwash and/or other breath fresheners that morning. Anthropomorphic, blood pressure, and EndoPATTM recordings will be made. Saliva will be stored. Blood will be drawn and stored. Subjects will receive one animal-based dinner. Subjects will then leave the study center and they will consume their usual diet until 5pm. For the rest of the evening until 11pm they will consume only the dinner provided. Water will be the only beverage consumed after 5pm. Dinner should be consumed at 8:30pm, EST. Subjects will text pictures of all they consume (eat or drink) after 5pm to Dr. Ostfeld or to a study representative and s/he will have text or verbal contact with the subject at least once that evening. Subjects will fast other than water after 11pm. That night, subjects will do a Rigiscan™ assessment overnight at their home. The time the subject goes to bed and the time the subject wakes up for the day should be recorded. The subject agrees to be in bed with Rigiscan™ on (other than for emergency or needed trips to the bathroom) for at least seven hours. Visit 6 Subjects return to the study center the morning after the Rigiscan™ assessment and bring the Rigiscan™ device. They will not brush their teeth or use mouthwash and/or other breath fresheners that morning. Anthropomorphic, blood pressure, and EndoPATTM recordings will be made. Saliva will be stored. Blood will be drawn and stored. Subjects will then receive one full day of animal-based meals. Subjects will be encouraged to eat breakfast at the study center after the initial anthropomorphic measures are made, saliva is obtained, and blood is drawn. Subjects will text pictures of all they consume during that day to Dr. Ostfeld and/or to a study representative and s/he will have text or verbal contact with the subject at least twice during that day. Dinner should be consumed at 8:30pm, EST. Subjects will fast other than water after 11pm. That night, subjects will do a Rigiscan™ assessment overnight at their home. Black coffee and/or tea is permitted only before noon. The time the subject goes to bed and the time the subject wakes up for the day should be recorded. The subject agrees to be in bed with Rigiscan™ on (other than for emergency or needed trips to the bathroom) for at least seven hours. Visit 7 (study end) Subjects return to the study center the morning after the Rigiscan™ assessment and bring the Rigiscan™ device. They will not brush their teeth or use mouthwash and/or other breath fresheners that morning. Anthropomorphic, blood pressure, and EndoPATTM recordings will be made. Saliva will be stored. Blood will be drawn and stored. Sequence Two: Sequence Two is identical to Sequence One, except that animal-based meals are provided instead of plant-based meals.

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