CTRI/2023/05/052652已完成Unknown
A randomized, double blind, placebo-controlled clinical study to evaluate the effect of LI12542F6 supplementation on Testosterone level and its tolerability in healthy ageing males
aila Nutraceuticals0 个研究点目标入组 69 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 69
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Healthy males aged between 40-65 years with a Body Mass Index (BMI) of 22-29 kg/m2.
- •2.Subjects with total Testosterone levels > 300ng/dL.
- •3.Subjects who are recreationally active (Participating in any cardiovascular exercise
- •like cycling, jogging, brisk walking, running, swimming not more than five times weekly) but not participating in resistance training.
- •4.Subjects agree to maintain current diet and activity level.
- •5.Subject considered generally healthy as per the investigator opinion from health history and routine clinical investigations.
- •6.Ability to understand the risks and benefits of the protocol.
- •7.Subject should provide written informed consent and agree to be available throughout the study duration for follow-ups.
- •8.Subject agrees not to start any new therapies for sexual health or energy boosting or protein or testosterone supplements or health drinks during the course of the study.
- •9.Subject agrees to not use supplements including vitamins and minerals or herbals for at least 15 days before screening visit, and for the duration of the study
- •10.Subjects agreed to refrain from drinking coffee or caffeinated drinks or beverages 24hrs before the evaluation days.
排除标准
- •1.Subjects underwent treatment for COVID 19 within last 3 months or tested positive during the study will be excluded.
- •2.Subjects with history of taking medications for erectile dysfunction, oligospermia or any other sexual problems, urinary & prostate diseases and muscular dystrophy.
- •3.Subjects with clinical history of endocrine disorders e.g. hypopituitarism, pituitary
- •tumors, hypo- and hyperthyroidism, hypogonadism, inherited (genetic and chromosomal) disorders,etc.
- •4.Subjects diagnosed with sleep apnea or related disorders.
- •5.Subjects consuming medications that caninterfere with muscle mass such as corticosteroids, testosterone replacement or anabolic drugs.
- •6.History of psychiatric disorder that may impair the ability of subjects to provide written informed consent.
- •7.Subjects consuming alcohol ( >3 standard drinks per week) or smokers ( >3 cigarettes per day).
- •8.Subjects who consume recreational drugs (such as cocaine, methamphetamine,
- •marijuana, etc.) or chewable tobacco products.
- •9.Subjects having history of Benign Prostate Hyperplasia (BPH), hypertension (BP >140/90 mmHg), diabetes (fasting plasma glucose >125 mg/dL), stroke, myocardial infarction, coronary artery disease, cardiac failure, angina, life-threatening arrhythmia within the past 6 months.
- •10.Subjects under medications including anti-hypertensives, antidepressants,anticholinergics, inhaled beta agonists,anti-hyperlipidemics, psychotropics etc.
- •11.Subjects using any centrally acting anorectic agents, drugs that inhibit the absorption of nutrients and endocannabinoid neuromodulators during the two weeks prior to enrolment into the study.
- •12.Subjects who underwent major surgical procedures in last 6 months.
- •13.Subject with HIV positive or any other STDs.
- •14.Subject has participated in a clinical study within the last 30 days prior to recruitment
- •or concurrently participating in another study
研究者
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