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Trial registered on ANZCTR


Registration number
ACTRN12616000938404
Ethics application status
Approved
Date submitted
11/07/2016
Date registered
15/07/2016
Date last updated
28/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
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.
Scientific title
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.
Secondary ID [1] 289626 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Body composition 299410 0
Muscle Strength 299453 0
Physical Stamina 299454 0
Muscle Recovery 299455 0
Condition category
Condition code
Alternative and Complementary Medicine 299390 299390 0 0
Herbal remedies
Physical Medicine / Rehabilitation 299391 299391 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 295239 0
Treatment: Other
Comparator / control treatment
The placebo is 1 capsule taken in the morning and evening of excipient ingredients only.
Control group
Placebo

Outcomes
Primary outcome [1] 298858 0
Muscle Strength, as measured by
a. 1-RM Leg Press
b. 1-RM Bench Press
Timepoint [1] 298858 0
Baseline, week 4 and week 8
Primary outcome [2] 298859 0
Muscular Endurance as measured by
a. 80% 1-RM leg press reps to fatigue
b. 80% 1-RM bench press reps to fatigue
Timepoint [2] 298859 0
Baseline, week 4 and week 8
Secondary outcome [1] 325456 0
lean muscle mass measured by DEXA scan
Timepoint [1] 325456 0
Baseline and week 8
Secondary outcome [2] 325457 0
Muscle size – The maximal cross-sectional area (CSA) will be calculated from the girth and skin-fold measurements using tape measure and calipers
Timepoint [2] 325457 0
Baseline and week 8
Secondary outcome [3] 325458 0
Leg Power – as measured by output on a bicycle pedal
Timepoint [3] 325458 0
Baseline, week 4 and week 8
Secondary outcome [4] 325459 0
Muscle Fatigue and Recovery - Creatine Kinase (CK) via blood test
Timepoint [4] 325459 0
Baseline and week 8
Secondary outcome [5] 325460 0
Pathology – stress indicators (cortisol) via blood test
Timepoint [5] 325460 0
Baseline and week 8
Secondary outcome [6] 325461 0
Quality of life as assessed by 36-item short form health survey
Timepoint [6] 325461 0
Baseline and week 8
Secondary outcome [7] 325601 0
Fat Mass - measured accord to DEXA Scan
Timepoint [7] 325601 0
Baseline and week 8
Secondary outcome [8] 325602 0
Body fat percentage measured by DEXA scan
Timepoint [8] 325602 0
Baseline and week 8
Secondary outcome [9] 325603 0
BMI - calculated according to DEXA scan measures
Timepoint [9] 325603 0
Baseline and week 8
Secondary outcome [10] 325604 0
Body weight - measured by scale
Timepoint [10] 325604 0
Baseline and week 8
Secondary outcome [11] 325605 0
Waist circumference - measured by tape measure
Timepoint [11] 325605 0
Baseline and week 8
Secondary outcome [12] 325606 0
Muscle fatigue and recovery measured by lactate dehydrogenase via blood test
Timepoint [12] 325606 0
Baseline and week 8
Secondary outcome [13] 325607 0
Pathology - Liver function test via blood test
Timepoint [13] 325607 0
Baseline and week 8
Secondary outcome [14] 325608 0
Pathology - Kidney function via blood test
Timepoint [14] 325608 0
Baseline and week 8
Secondary outcome [15] 325609 0
Pathology - Testosterone hormone via blood test
Timepoint [15] 325609 0
Baseline and week 8
Secondary outcome [16] 325610 0
Pathology - inflammation c-reactive protein via blood test
Timepoint [16] 325610 0
Baseline and week 8
Secondary outcome [17] 325611 0
Pathology - Blood glucose and insulin
Timepoint [17] 325611 0
Baseline and week 8
Secondary outcome [18] 325612 0
Pathology - Homocysteine - via blood test
Timepoint [18] 325612 0
Baseline and week 8
Secondary outcome [19] 325613 0
Pathology - Full blood count
Timepoint [19] 325613 0
Baseline and week 8
Secondary outcome [20] 325614 0
Pathology - glutathione - via blood test
Timepoint [20] 325614 0
Baseline and week 8
Secondary outcome [21] 325615 0
Pathology - reactive oxygen species - via blood test
Timepoint [21] 325615 0
Baseline and week 8
Secondary outcome [22] 325616 0
Pathology - malonyldialdehyde - via blood test
Timepoint [22] 325616 0
Baseline and week 8

Eligibility
Key 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
Minimum age
25 Years
Maximum age
45 Years
Gender
Males
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The potential participants are screened by the investigator for inclusion in the study. The eligible participants are enrolled by investigator and provided with a "Numbered Container" that is identical to all other containers and contains the same information on the label, except for the number. The investigator is blinded to the product randomized with the
numbered containers labelled prior to delivery to investigational site. Product allocated as participants are enrolled in sequential order (1-120).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer randomized software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 294012 0
Commercial sector/Industry
Name [1] 294012 0
Gencor Pacific
Address [1] 294012 0
21-E, Elegance Court
Hillgrove Village
Discovery Bay

Country [1] 294012 0
Hong Kong
Funding source category [2] 294039 0
Commercial sector/Industry
Name [2] 294039 0
Pharmako Biotechnologies Pty Ltd
Address [2] 294039 0
Campbell Ave Cromer
NSW 2099 AUS
Country [2] 294039 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Integrated Health Global Pty Ltd
Address
3B/76 Doggett St, Newstead, QLD 4006
Country
Australia
Secondary sponsor category [1] 292830 0
Individual
Name [1] 292830 0
Dr David Briskey
Address [1] 292830 0
School of Human Movement and Nutrition Sciences
Faculty of Health and Behavioural Sciences
University of Queensland
St Lucia, QLD 4072
Country [1] 292830 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295421 0
BellBerry Limited
Ethics committee address [1] 295421 0
129 Glen Osmond Road
Eastwood South Australia 5063
Ethics committee country [1] 295421 0
Australia
Date submitted for ethics approval [1] 295421 0
12/05/2016
Approval date [1] 295421 0
01/07/2016
Ethics approval number [1] 295421 0

Summary
Brief 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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67230 0
Dr David Briskey
Address 67230 0
School of Human Movement and Nutrition Sciences
University of Queensland
St Lucia QLD 4027
Country 67230 0
Australia
Phone 67230 0
+61 421 784 077
Fax 67230 0
Email 67230 0
d.briskey@uq.edu.au
Contact person for public queries
Name 67231 0
Ms Amanda Rao
Address 67231 0
Integrated Health Global Pty Ltd 3B/76 Doggett St, Newstead, QLD 4006
Country 67231 0
Australia
Phone 67231 0
+61 414 488 559
Fax 67231 0
Email 67231 0
amanda@rdcglobal.com.au
Contact person for scientific queries
Name 67232 0
Ms Amanda Rao
Address 67232 0
Integrated Health Global Pty Ltd 3B/76 Doggett St, Newstead, QLD 4006
Country 67232 0
Australia
Phone 67232 0
+61 414 488 559
Fax 67232 0
Email 67232 0
amanda@rdcglobal.com.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary