To evaluate the effect of LI12542F6 supplementation on Testosterone level and its tolerability

Not Applicable

Completed

Registration Number: CTRI/2023/05/052652

Lead Sponsor: aila Nutraceuticals

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 69

Inclusion Criteria

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.

Exclusion Criteria

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