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New treatment option for Erectile Dysfunction
Official title The Impact of Dietary Pattern on Erectile Function
ClinicalTrials.gov ID: NCT04349059
What this study is testing
- What it's testing
- The goal of this study is to determine whether erectile function is impacted by dietary patterns in healthy men with normal erectile function.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 35, men only. Healthy volunteers may be eligible.
You may be able to join if
- Subject provides written informed consent and HIPAA authorization in English before any study procedures are conducted.
- Subject is taking no medical therapy other than: prn MDIs, medication(s) for anxiety, depression, and/or ADHD (these medications include, but are not...
- IIEF score greater or equal to 22
- Subject will have had penile-sexual intercourse (either vaginal or anal penetration) within 12 weeks of enrollment.
- Male aged 18-35 years old
You likely can't join if
- 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...
- BMI \>=30, BMI \<18.5, or weight \<= 110lbs
- Known chronic medical disease other than non-inflammatory musculoskeletal disease, asthma, anxiety, depression, and/or ADHD. people who have had...
See the full eligibility criteria
Who can join
- Subject provides written informed consent and HIPAA authorization in English before any study procedures are conducted.
- Subject is taking no medical therapy other than: prn MDIs, medication(s) for anxiety, depression, and/or ADHD (these medications include, but are not limited to, SSRIs, SNRIs, Stimulants), no change in supplements if...
- IIEF score greater or equal to 22
- Subject will have had penile-sexual intercourse (either vaginal or anal penetration) within 12 weeks of enrollment.
- Male aged 18-35 years old
- Lives within commuting distance of Montefiore Health System
- Subject's significant other (if applicable) agrees to support the subject during the study
- Subject agrees to photograph and share all items consumed/drunk during the dietary intervention
- Subject agrees to 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 agrees to refrain from sexual activity for at least 24 hours prior to Rigiscan™ placement and to have no sexual activity on the days and nights of Rigiscan™ recording.
- Subject agrees to not view, read, or otherwise consume erotic or pornographic material for 24 hours prior to both the days and nights of Rigiscan™ recording and on the days and nights of Rigiscan™ recording.
- Subject agrees to not have an orgasm for 24 hours prior to both the days and nights of RigiscanTM 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, to begin fasting at 11pm the night before each visit, and to undergo all blood draws/salivary/other testing.
- Subject agrees to not use mouthwash or mouth rinses or intentionally spit for the entire duration of the study. people will be asked to refrain from using mouthwash for at least 2 days prior to enrollment. Subject...
- 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, people will exercise for the same amount of time and at a similar intensity each day of Rigiscan™ testing. Otherwise, no exercise will be performed on Rigiscan™ days.
- If enrolled, people agree to 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.
What rules you out
- 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...
- BMI \>=30, BMI \<18.5, or weight \<= 110lbs
- Known chronic medical disease other than non-inflammatory musculoskeletal disease, asthma, anxiety, depression, and/or ADHD. people who have had changes in the dosage or type of their medication(s) for anxiety...
- 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 the investigator's opinion, may confound the study results, or may interfere significantly 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
- The subject is trans-gender
- 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 the study
- Subject reports any communicable skin or venereal disease
- Subject reports rash or lesion on the penis or surrounding area.
- STOP-Bang score \> 2
- Having the diagnosis of Restless Leg Syndrome.
- Having insomnia as defined by: Subject with insomnia would have difficulty initiating or maintaining sleep (30 minutes or more at sleep initiation or 30 minutes or more to fall back asleep if wakes during the night)...
The study team makes the final eligibility decision.
Where it's taking place
- The Bronx, New York, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 35 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include The Bronx, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.