CompletedPhase 3Phase 4ACTRN12616000938404

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.


Sponsor

Integrated Health Global Pty Ltd

Enrollment

120 participants

Start Date

Aug 2, 2016

Study Type

Interventional

Conditions

Summary

This is 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.


Eligibility

Sex: MalesMin Age: 25 YearssMax Age: 45 Yearss

Inclusion Criteria7

  • 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 Criteria16

  • 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

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Interventions

The investigational product is an ARTG listed (Aust L 187766) commercially available capsule-form herbal medicine containing 300mg Trigonella foenum- graecum (Fenugreek) seed extract. The daily dose w

The investigational product is an ARTG listed (Aust L 187766) commercially available capsule-form herbal medicine containing 300mg Trigonella foenum- graecum (Fenugreek) seed extract. The daily dose will be 1 capsule taken in the morning and evening (total 2 capsules per day) for a period of 8 weeks. Active ingredient: Trigonella foenum-graecum extract 300mg equivalent to dry seed 9.9g Excipient ingredients: Maltodextrin All participants are provided with a bottle of the product (active or placebo) and be asked to complete 3 set training sessions weekly. Participants will undertake muscle strength testing at baseline, week 4 and week 8. Participants will undertake a body composition assessment at baseline and week 8. At baseline and week 8, the following questionnaires will be completed 36-item Short Form Health Survey and Food frequency diary. The following blood tests will be performed at baseline and week 8 to assess the effect of the product and for safety measures, liver function, Bilirubin, full blood count, creatinine/eGFR, Homocysteine, glutathione, malonyldialdehyde, reactive oxygen species, c-reactive protein, blood glucose and tolerance, cortisol and testosterone. Adherence to the intervention will be monitored by drug tablet return. Exercise Schedule Each exercise session will run for approximately 15mins and involves: 1. a warm-up/light stretch and mobility phase (approx 5 mins) 2. targeted resistance phase (changing on a weekly basis) (approx 10-15mins) 3. cool down and mobility stretch (approx 5 mins); and 4. recovery phase (in own time) Participants undertaken 3 exercise training sessions weekly and at baseline, week 4 and week 8 a strength and exercise performance assessment. In the first week there will be a strong emphasis on technique and not doing any more or less than what is given. Furthermore, a clear understanding of any previous injuries or restrictions anyone might have. As this week goes on, exercises will become more intense and depending each participants ability, the exercise will be modified to become more challenging. Types of exercise range from core (eg sit-ups), weights (eg one arm rows, kettle bell swings), body strength (eg lunges, push ups). Participation at each training session will be signed off. The exercise sessions are led by a qualified personal trainer and overseen by a Exercise Physiologist.


Locations(1)

QLD, Australia

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