A double-blind, randomised, placebo-controlled interventional study to evaluate the effect of orally-dosed herbal extract, Testofen (Trigonella foenum-graecum) on muscle strength, endurance and body composition in women aged between 25 and 45 years.
- Conditions
- Body compositionmuscle strengthphysical staminamuscle recoveryAlternative and Complementary Medicine - Herbal remediesPhysical Medicine / Rehabilitation - Other physical medicine / rehabilitation
- Registration Number
- ACTRN12618001538235
- Lead Sponsor
- RDC Global Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 127
Males and females aged 25-45 years
BMI 18.5-29.9 – Participants to be in the healthy to overweight range
Not currently undertaking resistance training exercise
Lightly trained – undertaking low impact cardiovascular exercise including but not limited to cycling, swimming and walking not more than 5 x weekly
Written informed consent from the participant
Willing to participate in an exercise program 3 x per week
Currently undertaking resistance training exercise
Clinically significant medical conditions including, but not limited to, cardiovascular,
neurological, psychiatric, renal, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or haemotogical abnormalities that are uncontrolled.
Consumption of any dietary supplements in the last 3 months
Known hypersensitivity to herbal drugs/nutritional supplement/ foods
Substantial alcohol consumption (21 drinks per week for men), drug use, or other confounding conditions
Patients on prolonged (= 6 weeks) medication with corticosteroids, antidepressants,
anticholinergics etc. or any other drugs that may have an influence on the outcome of the
study.
Severe Pulmonary Dysfunction (uncontrolled Bronchial Asthma and / or Chronic Obstructive
Participants who have completed participation in any other clinical trial during past 6 months
History of orthopedic injuries or surgery in the past 6 months
Females trying to fall pregnant or are pregnant or lactating*
Active smokers
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Muscle strength measured by 1-RM leg press [Baseline, week 4 and 8 (primary timepoint)];Muscle strength measured by 1-RM bench press [Baseline, week 4 and 8 (primary timepoint)];Muscular endurance as measured by 80% 1-RM leg press reps to fatigue [Baseline, week 4 and 8 (primary timepoint)]
- Secondary Outcome Measures
Name Time Method