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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Percent of time ≥60% erect during overnight Rigiscan™ use after 4 meals.
研究概览
简要总结
The goal of this study is to determine whether erectile function is impacted by dietary patterns in healthy men with normal erectile function.
详细描述
Visit 1:
After reviewing and signing consent, subjects will be screened for the study. Screening will consist of the following:
- Complete International Index of Erectile Function (IIEF) questionnaire.
- Record medical history, concomitant medications
- Measure height and weight, calculate BMI
- Vitals
- Draw blood for total testosterone, sex hormone binding globulin and Thyroid Stimulating Hormone
- Query subject regarding the presence of genital rash or lesions. Subjects will be asked, "do you have a rash or lesion on your penis or surrounding area?"
If the IIEF score is abnormal, subjects will be advised to contact their primary care provider.
Each subject will be contacted by phone with their blood results. If abnormal subject will be given the recommendation to contact his primary care provider.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcomes assessor will be blinded to randomization group and order of testing.
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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.
- •The anxiety, depression, and/or ADHD will have been controlled (per report of subject) for the last 6 months.
- •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.
排除标准
- •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.
- •Subjects who have had changes in the dosage or type of their medication(s) for anxiety, depression, and/or ADHD within 3 months of enrollment.
- •Subjects who have scheduled or planned medication and/or medication dose changes during the study period. These medication changes include the initiation of a new medication, discontinuation of a medication, modification of medication dose, and/or the route of administration of a medication.
- •Subjects who are taking benzodiazepines and/or beta blockers
- •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.
研究组 & 干预措施
Plant-based arm
The plant-based arm consists of 3 visits to the clinical research center, following a plant-based diet and using the Rigiscan™ device to measure the frequency, rigidity, and duration of nocturnal erections.
干预措施: Plant based diet (Other)
Animal-based arm
The animal-based arm consists of 3 visits to the clinical research center, following an animal- based diet and using the Rigiscan™ device to measure the frequency, rigidity, and duration of nocturnal erections.
干预措施: Animal based diet (Other)
结局指标
主要结局
Percent of time ≥60% erect during overnight Rigiscan™ use after 4 meals.
时间窗: During overnight Rigiscan™ use directly after consuming the 4 meals. (The second night of Rigiscan™ use).
The first 5 minutes of Rigiscan™ recording is discarded. Erection time is the total time (in minutes) when penile rigidity is ≥ 60% at both the tip and base of the penis with a concurrent increase in penile tumescence at both the tip and base of the penis compared to baseline tumescence as measured by Rigiscan™ during overnight Rigiscan™ use, divided by the total time (in minutes) of overnight Rigiscan™ use. Overnight Rigiscan™ use time is defined as starting 5 minutes after the start of the Rigiscan™ recording and the end of Rigiscan™ use is defined as the last time the tip or base was \>=10% rigid with a corresponding concurrent increase in penile tumescence at the tip or base compared to baseline tumesence. This total time window from start to end is the Rigiscan™ use time.
次要结局
- Percent of time ≥60% erect during overnight Rigiscan™ use after 1 meal.(During overnight Rigiscan™ use directly after consuming 1 meal. (The first night of Rigiscan™ use).)
- Percent of time ≥60% erect during overnight Rigiscan™ use after 4 meals, where each erection lasts >=5 minutes as measured by Rigiscan™(During overnight Rigiscan™ use directly after consuming 4 meals. (The second night of Rigiscan™ use).)
- Percent of time ≥60% erect during overnight Rigiscan™ use after 1 meal, where each erection lasts >=5 minutes as measured by Rigiscan™(During overnight Rigiscan™ use directly after consuming 1 meal. (The first night of Rigiscan™ use).)