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.
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.
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).
Parallel
RhizomK
DrugRhizomK 50 mg once daily
Plcebo
Other interventionPlacebo matching to RhizomK
Serum testosterone levels
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.
Serum cortisol levels
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)
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
1-repetition maximum (1-RM) determined for the leg press
Adverse effect
Proportion of patients in each group experiencing adverse effects
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