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 men aged between 25 and 45 years.

Phase 3

Completed

• Conditions: Body composition; Muscle Strength; Physical Stamina; Muscle Recovery; Alternative and Complementary Medicine - Herbal remedies; Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation

• Registration Number: ACTRN12616000938404
• Lead Sponsor: Integrated Health Global Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-07-15
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 120

Inclusion Criteria

Males 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

Exclusion Criteria

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 (approximately 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 orthopaedic injuries or surgery in the past 6 months
Females
Active smokers

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Muscular Endurance as measured by<br>a. 80% 1-RM leg press reps to fatigue<br>b. 80% 1-RM bench press reps to fatigue[Baseline, week 4 and week 8];Muscle Strength, as measured by<br>a. 1-RM Leg Press<br>b. 1-RM Bench Press<br>[Baseline, week 4 and week 8]