About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Subject provides written informed consent and HIPAA authorization in English before any study procedures are conducted. (If the subject is a fluent Spanish and/or other language speaker, subject must also be fluent in English (understanding and speaking) to be eligible for this study.)
IIEF score greater or equal to 22
Subject is currently taking no medication other than prn MDIs No change in supplements if applicable
Subject will have had penile sexual intercourse (either vaginal or anal penetration) within 12 weeks of enrollment
Disqualifiers
Relevant dietary allergy
Vegetarian or Vegan dietary pattern
History of an eating disorder and/or food addiction
Hypertension and or history of hypertension with or without medical treatment. Systolic blood pressure > 150mmHg and/or diastolic blood pressure >100mmHg on Visit one. Heart rate >99 on Visit one. Systolic blood pressure < 85mmHg and/or diastolic blood pressure < 50mmHg on Visit one. Heart rate < 35 on Visit one
Trial design
Crossover
Treatments tested in this trial
Animal-based meal
Other interventionConsuming a single plant-based meat or a single animal meat meal and measuring the meals impact on erectile function with the Rigiscan™ device.
Plant-based meat meal
Other interventionConsuming a single plant-based meat or a single animal meat meal and measuring the meals impact on erectile function with the Rigiscan™ device.
Treatment groups
Trial outcomes
Primary outcomes
Percent of time with ≥70% erection during overnight sleep after 1 meal
Total time (in minutes) when penile rigidity is ≥70% at both the tip and the base of the penis as measured by Rigiscan™ during overnight sleep, divided by the total time (in minutes) of overnight sleep. Overnight sleep is defined as the time in minutes from the onset of the first nocturnal erection to the end of the last nocturnal erection (as measured by Rigiscan™).
Secondary outcomes
Erection events per hour during overnight sleep after 1 meal
Total number of erection events lasting ≥5 minutes and with ≥70% rigidity at both the tip and the base of the penis as measured by Rigiscan™ during overnight sleep. Overnight sleep is defined as the time in minutes from the onset of the first nocturnal erection to the end of the last nocturnal erection (as measured by Rigiscan™). This result will be reported as Erection Events/hour.
Tumescence events per hour during overnight sleep after 1 meal.
Total number of tumescence events lasting ≥5 minutes and when penile circumference increases by ≥2cm at both the tip and the base of the penis compared to their respective baselines as measured by Rigiscan™ during overnight sleep, divided by the total time (in minutes) of overnight sleep. Overnight sleep is defined as the time in minutes from the onset of the first nocturnal erection to the end of the last nocturnal erection (as measured by Rigiscan™). This result will be reported as Tumescence events/hour.
Other outcomes
Heart rate
Comparing heart rate by dietary pattern at both time points after overnight sleep after consuming the 1 meal and compared to its respective baseline in beats/minute.
Blood pressure
Comparing blood pressure (both systolic and diastolic) by dietary pattern at both time points after overnight sleep after consuming the 1 meal and compared to its respective baseline in mmHg.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.