Adult Healthy Volunteers
Conditions
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 contribute to improved exercise performance, lean muscle gain, and subjective vitality. 13 However, despite encouraging preclinical and ethnopharmacological data, clinical validation of Curculigo extract in human participants-especially in the context of exercise and lifestyle enhancement-is lacking. A novel extract of Curculigo orchioides (commercially known as RhizomK™) has been developed. This randomized, double-blind, placebo-controlled study seeks to bridge this crucial gap by evaluating the efficacy and safety of RhizomK™ supplementation in healthy, physically active males. The findings of this study have the potential to substantiate RhizomK™ as a scientifically supported dietary intervention for enhancing hormonal balance, physical performance, and well-being in men who are not candidates for pharmacological therapy but are seeking to optimize their health through lifestyle and supplementation.
Interventions
DRUGRhizomK
RhizomK 50 mg once daily
OTHERPlcebo
Placebo matching to RhizomK
Sponsors
All India Institute of Medical Sciences, Bhubaneswar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
21 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum testosterone levels | 4 weeks | A basal pre- intervention Saliva sample will be obtained for analysis of basal (resting) testosterone levels. One hour after ingestion of the assigned study product, the subject will undergo an acute resistance exercise routine. Resistance exercise will include the Leg Press. The post resistance-exercise session Salivary/Serum Testosterone samples within \ 30 minutes of completing the exercise routine will be collected. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum cortisol levels | 4 weeks | A basal pre- intervention Saliva sample will be obtained for analysis of basal (resting) cortisol levels. One hour after ingestion of the assigned study product, the subject will undergo an acute resistance exercise routine. Resistance exercise will include the Leg Press. The post resistance-exercise session Cortisol samples within \ 30 minutes of completing the exercise routine will be collected. |
| Quality of life using SF-36 (Short Form 36-Item Health Survey) | 4 weeks | The SF-36, or 36-Item Short Form Survey, is a widely used patient-reported outcome measure (PROM) that assesses health status. It's a multi-purpose questionnaire with 36 items assessing eight health concepts: physical functioning, limitations in social activities, limitations in usual role activities, bodily pain, general mental health, vitality, and general health perceptions. |
| Exercise performance | 4 weeks | 1-repetition maximum (1-RM) determined for the leg press |
| Adverse effect | 4 weeks | Proportion of patients in each group experiencing adverse effects |
Countries
India
Contacts
Primary ContactDebasish Hota, DM
Backup ContactRituparna Maiti, MD
Outcome results
None listed