The Impact of a Plant-based Meat Meal Versus an Animal Meat Meal on Erectile Function in Healthy Men.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-32
SponsorMontefiore Medical Center

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 volunteers

Qualifiers

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

Design model

Crossover

Treatments tested in this trial

  • Animal-based meal

    Other intervention

    Consuming 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 intervention

    Consuming 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

30 Participants
are divided into 2 treatment groups
Group A: Plant-basedActive comparator 1 intervention
Group B: Animal-basedActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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™).

Time frame
During overnight sleep directly after consuming the 1 meal. Up to 7 months.

Secondary outcomes

1

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.

Time frame
During overnight sleep directly after consuming the 1 meal. Up to 7 months.
2

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.

Time frame
During overnight sleep directly after consuming the 1 meal. Up to 7 months.

Other outcomes

1

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.

Time frame
Pre and post overnight Rigiscan recording. Up to 7 months.
2

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.

Time frame
Pre and post overnight Rigiscan recording. Up to 7 months.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Montefiore Medical Center

Lead sponsor

Beyond Meat

Collaborator

San Diego Sexual Medicine

Collaborator