CTRI/2023/05/052652已完成不适用
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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change from baseline to the end of the study period inSerum total testosterone
研究概览
简要总结
The purpose of this study is to evaluate the effect of LI12542F6 supplementation on Testosterone levels in healthy ageing males. Enrolled subjects will receive either LI12542F6 or placebo daily in the morning for 56 days
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Male
入选标准
- •1.Healthy males aged between 40-65 years with a Body Mass Index (BMI) of 22-29 kg/m
- •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.
结局指标
主要结局
Change from baseline to the end of the study period inSerum total testosterone
时间窗: Day 1 (Baseline), Day 7, Day 14, Day 28 and Day 56
次要结局
- Change from baseline to the end of the study in Grip strength (by using hand dynamometer(Day 1 (Baseline), Day 7, Day 14, Day 28 and Day 56)
- Change from baseline to the end of the study in Changes in sexual function questionnaire (CSFQ)(Day 1 (Baseline), Day 7, Day 14, Day 28 and Day 56)
- Change from baseline to the end of the study period inQuality of life questionnaire (SF-36 – Vitality scale only)(Day 1 (Baseline), Day 28 and Day 56)
- Change from baseline to the end of the study period in Perceived stress scale (PSS)(Day 1 (Baseline), Day 28 and Day 56)
- Change from baseline to the end of the study period in Cortisol(Day 1 (Baseline), Day 7, Day 14, Day 28 and Day 56)
- Change from baseline to the end of the study period in Sex hormone binding globulin (SHBG)(Day 1 (Baseline) and Day 56)
- Change from baseline to the end of the study period in Body composition (using DEXA) – including total fat, android fat and gynoid fat(Day 1 (Baseline) and Day 56)
- Change from baseline to the end of the study period in Athens insomnia scale (AIS)(Day 1 (Baseline), Day 28 and Day 56)
- Change from baseline to the end of the study period in Chalder fatigue scale (CFQ 11)(Day 1 (Baseline), Day 7, Day 14, Day 28 and Day 56)
- Change from baseline to the end of the study period in Serum free testosterone(Day 1 (Baseline), Day 7, Day 14, Day 28 and Day 56)
- Change from baseline to the end of the study period in Dihydrotestosterone (DHT)(Day 1 (Baseline), Day 7, Day 14, Day 28 and Day 56)
- Change from baseline to the end of the study period in Estradiol(Day 1 (Baseline) and Day 56)
- Change from baseline to the end of the study period in Testosterone : Estradiol(Day 1 (Baseline) and Day 56)
- Change from baseline to the end of the study period in DHEA(Day 1 (Baseline) and Day 56)
研究者
研究点 (1)
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