Status:
NOT_YET_RECRUITING
Effect of RhizomK on Testosterone Levels, the Anabolic Response to Exercise and Overall Quality of Life in Physically Active Healthy Males
Lead Sponsor:
All India Institute of Medical Sciences, Bhubaneswar
Conditions:
Adult Healthy Volunteers
Eligibility:
MALE
21-40 years
Phase:
NA
Brief Summary
Given that testosterone is a key modulator of muscle protein synthesis and overall anabolic response to resistance training, any natural intervention that boosts testosterone levels could logically co...
Eligibility Criteria
Inclusion
- Male sex, aged 21 to 40 (inclusive)
- Currently engaged in, and has been engaged in resistance training
- (i.e., weightlifting), training three or more times per week for at least
- the prior 12 months.
- Healthy subject (no medical conditions that per the PI assessment).
- No significant past medical history
- No significant past surgical history that in the opinion of the PI
- would preclude study participation.
- Passes the screening with Physical Activity Readiness questionnaire (PAR-Q)
- Not currently or recently (within the prior eight-weeks) taken a
- dietary supplement that is purported to increase testosterone
- levels.
- Agrees to follow and adhere to the study directions.
- Agrees that their study visits will be scheduled at a similar time of the day
- to minimize and potential circadian rhythm impacts.
Exclusion
- Takes any prescribed medication or over-the-counter medication which is known to affect testosterone levels.
- Positive medical history of heart disease/cardiovascular disease, high blood pressure (140/90 or greater mmHg), kidney disease, hepatic impairment or disease, or Type I or Type II diabetes or any other medical condition or diagnosis that the PI would deem exclusionary.
- Positive medical history of unstable thyroid disease, previously diagnosed major affective disorder, psychiatric disorder that required hospitalization in the prior year, immune disorder (i.e., HIV/AIDS), a history of cancer (except localized skin cancer without metastases or in situ cervical cancer within 5 years prior to screening visit.
- Positive medical history for any gastrointestinal disease or illness Positive history of gastrointestinal surgery that is known to alter or impact the digestion, absorption of nutrients and or fluids (i.e., gastric bypass).
- History of hospitalization or in-patient or out-patient treatment for alcohol dependence or drug addiction over the past one year.
- History of hospitalization or in-patient treatment for depression or any mental health related condition within the past one year.
- Allergic to any of the ingredients in the study product.
- Subject is unwilling to follow study directions.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07143474
Start Date
October 1 2025
End Date
February 1 2027
Last Update
September 4 2025
Active Locations (1)
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1
All India Institute of Medical Sciences
Bhubaneswar, Odisha, India, 751019