Phase
Condition
Erectile Dysfunction
Impotence
Infertility
Treatment
Animal-based meal
Plant-based meat meal
Clinical Study ID
Ages 18-32 Male Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject provides written informed consent and HIPAA authorization in English beforeany study procedures are conducted. (If the subject is a fluent Spanish and/or otherlanguage speaker, subject must also be fluent in English (understanding andspeaking) 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 insupplements if applicable
Subject will have had penile sexual intercourse (either vaginal or anal penetration)within 12 weeks of enrollment
Male (biological) aged 18-32 years old
Lives within commuting distance of Montefiore Health System
Subject's significant other (if applicable) agrees to support the subject during thestudy
Subject agrees to avoid all illicit drugs, NSAIDS, and alcohol for at least two daysprior 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 toRigiscan™ placement and to have no sexual activity on the days and nights ofRigiscan™ recording
Subject agrees to not view, read, or otherwise consume erotic or pornographicmaterial for at least 24 hours prior to the days and nights of Rigiscan™ recordingand on the days and nights of Rigiscan™ recording
Subject agrees to not have an orgasm for 24 hours prior to both the days and nightsof Rigiscan™ 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 and to undergo all blooddraws and other testing
Subject agrees to not use mouthwash or mouth rinses or intentionally spit for theentire duration of the study. Subjects will be asked to refrain from using mouthwashfor at least 2 days prior to enrollment. Subject agrees to not brush his teeth andto not use toothpaste for 24 hours preceding Rigiscan testing. Tooth brushing isotherwise permissible.
BMI <28.5, 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 asimilar intensity each day of Rigiscan™ testing. Otherwise, no exercise will beperformed on Rigiscan™ days.
If enrolled, subjects agree to not modify their dietary habits throughout theduration of the study other than during the two evenings when food is provided.
If enrolled, subjects agree to fast when requested to fast
Exclusion
Exclusion Criteria:
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 Visitone. Heart rate >99 on Visit one. Systolic blood pressure < 85mmHg and/or diastolicblood pressure < 50mmHg on Visit one. Heart rate < 35 on Visit one
BMI >=28.5, BMI <18.5, or weight <= 110lbs
Known chronic medical disease other than non-inflammatory musculoskeletal disease,asthma
Subjects who are taking benzodiazepines, stimulants (e.g. for ADHD), SSRI,anti-depressants and/or beta blockers
Obstructive sleep apnea (OSA) diagnosis or an ongoing evaluation for possible OSA
Score greater than 2 on the STOP-Bang OSA screening tool
Having the diagnosis of Restless Leg Syndrome
Having insomnia as defined by: Subject with insomnia would have difficultyinitiating or maintaining sleep (30 minutes or more at sleep initiation or 30minutes or more to fall back asleep if wakes during the night). The above occurs atleast 3 times per week for at least 1 month. Furthermore, there must be adequateopportunity for sleep and there must be associated morbidity (feels tired during theday). Definition based on: The International Classification of Sleep Disorders -Third Edition (ICSD-3), 2014
History of kidney disease or hyperkalemia
Subject has received an investigational drug within 30 days prior to signing consent
Erectile dysfunction
Has any condition (e.g., psychiatric illness) or situation that, in theinvestigator's opinion, may confound the study results, or may interferesignificantly with the patient's ability to adhere with study procedures
Currently undergoing treatment for Peyronie's Disease
Abnormal Testosterone or Thyroid Stimulating Hormone level
Treated hypogonadism or hypothyroidism
Planned travel during the study
History of substance abuse in the last 12 months
Illicit drug use, smoking, or vaping within 4 weeks
Upper respiratory illness within two weeks on screening
If profession requires being on call, no overnight or on call duties during thestudy
Subject reports any communicable skin or venereal disease
Transgender status (Individuals who have undergone or are undergoing hormonereplacement therapy or who have undergone gender affirming surgery. Individuals whoplan to begin hormone replacement therapy or to undergo gender affirming surgeryduring the study.)
HIV positive status via direct medical history
Subject reports rash or lesion on the penis or surrounding area
Study Design
Study Description
Connect with a study center
Montefiore Medical Center
Bronx, New York 10467
United StatesActive - Recruiting
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