Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2025-12-27 @ 6:22 PM
Study NCT ID:
NCT06273592
Status:
RECRUITING
Last Update Posted:
2025-04-18
First Post:
2024-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of a Plant-based Meat Meal Versus an Animal Meat Meal on Erectile Function in Healthy Men.
Sponsor:
Montefiore Medical Center
Organization:
Study Overview
Official Title:
The Impact of a Plant-based Meat Meal Versus an Animal Meat Meal on Erectile Function in Healthy Men
Status:
RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ERECTION 2
Brief Summary:
The goal of this study is to determine whether erectile function is differentially impacted by a single plant-based meat meal versus a single animal meat meal in healthy men with normal erectile function.
Detailed Description:
Visit 1 (Screening Visit):
After reviewing and signing consent, subjects will be screened for the study. Screening will consist of the following:
* Complete IIEF
* Record medical history, concomitant medications
* Measure height and weight, calculate BMI
* Vitals
* A one-time blood draw of \~ 10 ml of blood will be performed during the screening visit for total testosterone, sex hormone binding globulin and Thyroid Stimulating Hormone.
* Query subject regarding the presence of genital rash or lesions. Subjects will be asked, "do you have a rash or lesion on your penis or surrounding area?"
If the IIEF score is abnormal, subjects will be advised to contact their primary care provider.
If the STOP-BANG score identified intermediate or high risk for OSA, subjects will be advised to contact their primary care provider.
If the subject has insomnia, the subject will be given the recommendation to contact their primary care provider.
Each subject will be contacted by phone with their blood results. If abnormal, subject will be given the recommendation to contact their primary care provider.
If the subject has no primary care provider, contact information for primary care will be given.
Subjects meeting inclusion and exclusion criteria will be randomized into the study, into either sequence one or sequence two. Once enrolled, subjects will be asked to not modify their dietary habits throughout the duration of the study other than during the two evenings when food is provided (see below).
Sequence One:
Visit 2:
Subjects will return to the study center. Subjects will be asked not to use mouthwash and/or other breath fresheners that day. Anthropomorphic and blood pressure and heart rate recordings will be made.
Subjects will be taught how to use the Rigiscan™ device. Subjects will receive one plant-based dinner (food will be provided by Montefiore-Einstein Food Services.) Subjects will then leave the study center and will consume their usual diet until 4pm EST. Water will be the only beverage allowed after 4pm. Dinner should be consumed at 8:30pm, EST. 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. After consuming the dinner, subject will only drink/consume water until the end of Rigiscan recording (at least 7 hours).
Visit 3:
Subjects will return to the study center the day after the Rigiscan™ assessment and bring the Rigiscan™ device with them. Anthropomorphic and blood pressure and heart rate recordings will be made.
There will then be a washout period for 5-8 days and subjects will be instructed to return to their usual dietary habits during this washout period.
Visit 4:
After the washout period, subjects will return to the study center. Subjects will have been asked not to use mouthwash and/or other breath fresheners that day. Anthropomorphic and blood pressure and heart rate recordings will be taken.
Subjects will receive one animal-based dinner (food will be provided by Montefiore-Einstein Food Services.) Subjects will then leave the study center and they will consume their usual diet until 4pm EST. Water will be the only beverage consumed after 4pm. Dinner should be consumed at 8:30pm, EST. 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. After consuming the dinner, subject will only drink/consume water until the end of Rigiscan recording (at least 7 hours).
Visit 5 (End of Study):
Subjects will return to the study center the day after the Rigiscan™ assessment and bring the Rigiscan™ device with them. Anthropomorphic and blood pressure and heart rate recordings will be made.
Sequence Two is identical to Sequence One, except that the order of the plant-based and animal-based meals is reversed.
After reviewing and signing consent, subjects will be screened for the study. Screening will consist of the following:
* Complete IIEF
* Record medical history, concomitant medications
* Measure height and weight, calculate BMI
* Vitals
* A one-time blood draw of \~ 10 ml of blood will be performed during the screening visit for total testosterone, sex hormone binding globulin and Thyroid Stimulating Hormone.
* Query subject regarding the presence of genital rash or lesions. Subjects will be asked, "do you have a rash or lesion on your penis or surrounding area?"
If the IIEF score is abnormal, subjects will be advised to contact their primary care provider.
If the STOP-BANG score identified intermediate or high risk for OSA, subjects will be advised to contact their primary care provider.
If the subject has insomnia, the subject will be given the recommendation to contact their primary care provider.
Each subject will be contacted by phone with their blood results. If abnormal, subject will be given the recommendation to contact their primary care provider.
If the subject has no primary care provider, contact information for primary care will be given.
Subjects meeting inclusion and exclusion criteria will be randomized into the study, into either sequence one or sequence two. Once enrolled, subjects will be asked to not modify their dietary habits throughout the duration of the study other than during the two evenings when food is provided (see below).
Sequence One:
Visit 2:
Subjects will return to the study center. Subjects will be asked not to use mouthwash and/or other breath fresheners that day. Anthropomorphic and blood pressure and heart rate recordings will be made.
Subjects will be taught how to use the Rigiscan™ device. Subjects will receive one plant-based dinner (food will be provided by Montefiore-Einstein Food Services.) Subjects will then leave the study center and will consume their usual diet until 4pm EST. Water will be the only beverage allowed after 4pm. Dinner should be consumed at 8:30pm, EST. 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. After consuming the dinner, subject will only drink/consume water until the end of Rigiscan recording (at least 7 hours).
Visit 3:
Subjects will return to the study center the day after the Rigiscan™ assessment and bring the Rigiscan™ device with them. Anthropomorphic and blood pressure and heart rate recordings will be made.
There will then be a washout period for 5-8 days and subjects will be instructed to return to their usual dietary habits during this washout period.
Visit 4:
After the washout period, subjects will return to the study center. Subjects will have been asked not to use mouthwash and/or other breath fresheners that day. Anthropomorphic and blood pressure and heart rate recordings will be taken.
Subjects will receive one animal-based dinner (food will be provided by Montefiore-Einstein Food Services.) Subjects will then leave the study center and they will consume their usual diet until 4pm EST. Water will be the only beverage consumed after 4pm. Dinner should be consumed at 8:30pm, EST. 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. After consuming the dinner, subject will only drink/consume water until the end of Rigiscan recording (at least 7 hours).
Visit 5 (End of Study):
Subjects will return to the study center the day after the Rigiscan™ assessment and bring the Rigiscan™ device with them. Anthropomorphic and blood pressure and heart rate recordings will be made.
Sequence Two is identical to Sequence One, except that the order of the plant-based and animal-based meals is reversed.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: