RECRUITING

The Impact of Dietary Pattern on Erectile Function

Conditions

Erectile Dysfunction Diet Erectile function Plant-based Animal-based

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this study is to determine whether erectile function is impacted by dietary patterns in healthy men with normal erectile function.

Official Title

The Impact of a Plant-Based Diet Versus an Animal-Based Diet on Erectile Function in Healthy Men With Normal Erectile Function: The ERECTION Study

Quick Facts

Study Start:2023-10-30

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04349059

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 35 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* 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 applicable. * 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. Subjects will be asked to refrain from using mouthwash for at least 2 days prior to enrollment. Subject agrees to not brush his teeth in the morning of the day of each study visit. Tooth brushing is otherwise permissible. * BMI \<30, 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 a similar intensity each day of Rigiscan™ testing. Otherwise, no exercise will be performed on Rigiscan™ days. * If enrolled, subjects 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.	* 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. * BMI \>=30, BMI \<18.5, or weight \<= 110lbs * Known chronic medical disease other than non-inflammatory musculoskeletal disease, asthma, anxiety, depression, and/or ADHD. * 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 above occurs at least 3 times per week for at least 1 month. Furthermore, there must be adequate opportunity for sleep and there must be associated morbidity (feels tired during the day). Definition based on: The International Classification of Sleep Disorders - Third Edition (ICSD-3), 2014.

Inclusion Criteria

Exclusion Criteria

* 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 applicable.
* 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. Subjects will be asked to refrain from using mouthwash for at least 2 days prior to enrollment. Subject agrees to not brush his teeth in the morning of the day of each study visit. Tooth brushing is otherwise permissible.
* BMI \<30, 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 a similar intensity each day of Rigiscan™ testing. Otherwise, no exercise will be performed on Rigiscan™ days.
* If enrolled, subjects 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.

* 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.
* BMI \>=30, BMI \<18.5, or weight \<= 110lbs
* Known chronic medical disease other than non-inflammatory musculoskeletal disease, asthma, anxiety, depression, and/or ADHD.
* 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 above occurs at least 3 times per week for at least 1 month. Furthermore, there must be adequate opportunity for sleep and there must be associated morbidity (feels tired during the day). Definition based on: The International Classification of Sleep Disorders - Third Edition (ICSD-3), 2014.

Contacts and Locations

Study Contact

Robert Ostfeld, MD

CONTACT

718-920-5197

ROSTFELD@montefiore.org

Principal Investigator

Robert Ostfeld, MD

PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Study Locations (Sites)

Montefiore Medical Center, Department of Medicine, Division of Cardiology

Bronx, New York, 10467

United States

Collaborators and Investigators

Sponsor: Montefiore Medical Center

Robert Ostfeld, MD, PRINCIPAL_INVESTIGATOR, Montefiore Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-30

Study Completion Date2025-12

Study Record Updates

Study Start Date2023-10-30

Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

Diet
Erectile function
Plant-based
Animal-based

Additional Relevant MeSH Terms

Erectile Dysfunction