Clinical trial investigating the effect of tongkat ali (Physta) on anabolic hormone markers, body composition and muscular strength in middle-aged males.

This study will use an 13-week double-blind, placebo-controlled, repeated measures parallel design. Participants will be randomised to receive either Physta® or placebo. Following baseline measurements in week 1, the study will have two phases. Phase one will be a lead in period of three weeks (week 2-4) where participants will start their supplementation protocol and take either the intervention supplement or placebo. Following this period, phase two (weeks 5-12) is when participants will continue with the supplementation protocol and begin the eight-week strength training intervention. Study participants will be randomised (double blind) to either receive 400mg/day of Physta or a placebo over an 11 week period. These will be in tablet form and taken orally. Participant compliance with supplement and strength training intervention will be assessed through a combination of monitoring by the lead researcher through weekly online check-ins through group chat methods using suitable apps (WhatsApp) and through group and personal email communication. Participants who report not being compliant with the supplementation protocol will be reminded of their obligation regarding appropriate study compliance. Study participants will be asked to record any missed supplementation intake in the Supplement Compliance Diary and return any unused supplements at the end of the study where pill counts will be carried out. The lead researcher will review diaries at the end of the study to verify adherence and reconcile discrepancies between diary entries and pill counts. The study will be carried out at the University of Canberra and the strength training intervention at the Fit and Well fitness centre at the Canberra Institute of Technology (CIT). Following the phase one period (week 2 - 4) all study participants will commence an eight week strength training program. The intervention and placebo group will complete the same strength training program. Study participants will be allocated an Exercise Physiology student completing placement hours who will supervise them for the duration of the strength training program. These students will be supervised by the lead researcher and a qualified Exercise Physiologist at CIT Fit and Well. The strength training program will be a four day a week program following an upper / lower body structure (training these areas two times a week). Training sessions will be in small groups (3-4 participants per student). The intensity of the strength training program will moderate to vigorous intensity (repetitions in reserve 2-3 per set) and each training session will be approximately 60 minutes. Training session adherence and completion will be monitored using a digital application developed through Replit where students will recorded each participants training session. See program structure and exercises below. Upper Body Exercises - Bench Press - Pec Fly Machine - Lat Pulldown - Seated Row - Machine Shoulder press - Face pulls - Standing DB Bicep curls - Triceps Pushdown - Russian Twists (loaded) Lower Body Exercises - Leg press - Dumbbell Bulgarian Split Squat - Deadlift - Leg Extension - Seated Leg curls - Standing Calf Raises - Back Extensions (loaded) All study participants will be required to cease intake of any type of dietary or herbal supplement which may impact hormonal status at least one month before baseline testing and discontinue the intake of this supplement for the duration of the study period. This study will be conducted by a qualified dietitian and sports dietitian, personal trainer and educator with experience spanning three decades in the areas of fitness, health and sport.