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Trial registered on ANZCTR


Registration number
ACTRN12618001538235
Ethics application status
Approved
Date submitted
28/08/2018
Date registered
14/09/2018
Date last updated
13/02/2019
Date data sharing statement initially provided
13/02/2019
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 women 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 women aged between 25 and 45 years.
Secondary ID [1] 295932 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record
This study is paired with the same study in men - ACTRN12616000938404

Health condition
Health condition(s) or problem(s) studied:
Body composition 309429 0
muscle strength 309430 0
physical stamina 309431 0
muscle recovery 309432 0
Condition category
Condition code
Alternative and Complementary Medicine 308279 308279 0 0
Herbal remedies
Physical Medicine / Rehabilitation 308280 308280 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 Trigonella foenum- graecum (Fenugreek) seed extract.

The daily dose will be 1 capsule taken in the morning and evening (total 2 capsules per day) of either 300mg or 600mg for a period of 8 weeks. The allocation is randomised.

All participants are provided with a bottle of the product (active or placebo) and be asked to complete 3 set training sessions weekly.

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. Except weeks week 4 and week 8 when a strength and exercise performance assessment will be undertaken and only two exercise sessions.

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] 312253 0
Treatment: Other
Comparator / control treatment
Placebo - 1 capsule in the morning and 1 capsule in the evening - made up of Maltodextrin
Control group
Placebo

Outcomes
Primary outcome [1] 307242 0
Muscle strength measured by 1-RM leg press
Timepoint [1] 307242 0
Baseline, week 4 and 8 (primary timepoint)
Primary outcome [2] 307243 0
Muscle strength measured by 1-RM bench press
Timepoint [2] 307243 0
Baseline, week 4 and 8 (primary timepoint)
Primary outcome [3] 307244 0
Muscular endurance as measured by 80% 1-RM leg press reps to fatigue
Timepoint [3] 307244 0
Baseline, week 4 and 8 (primary timepoint)
Secondary outcome [1] 351232 0
Primary: Muscular endurance as measured by 80% 1-RM bench press reps to fatigue
Timepoint [1] 351232 0
Baseline, weeks 4 and 8 (primary timepoint)
Secondary outcome [2] 351233 0
Lean muscle mass measured by DEXA scan
Timepoint [2] 351233 0
Baseline and week 8
Secondary outcome [3] 351234 0
Muscle size - The maximal cross-sectional area (CSA) will be calculated from the girth and skin-fold measurements using tape measure and callipers
Timepoint [3] 351234 0
Baseline and week 8
Secondary outcome [4] 351235 0
Leg power as measured by output on a bicycle
Timepoint [4] 351235 0
Baseline, week 4 and 8
Secondary outcome [5] 351236 0
Muscle fatigue and recovery - creating kinase CK via blood test
Timepoint [5] 351236 0
Baseline and week 8
Secondary outcome [6] 351237 0
Cortisol via blood test
Timepoint [6] 351237 0
Baseline and week 8
Secondary outcome [7] 351238 0
Quality of life measured by Short form 36-item health survey
Timepoint [7] 351238 0
Baseline and week 8
Secondary outcome [8] 351239 0
Fat mass measured by DEXA scan
Timepoint [8] 351239 0
Baseline and week 8
Secondary outcome [9] 351240 0
Body fat percentage measured by DEXA scan
Timepoint [9] 351240 0
Baseline and week 8
Secondary outcome [10] 351241 0
BMI calculated by DEXA scan
Timepoint [10] 351241 0
Baseline and week 8
Secondary outcome [11] 351242 0
Body weight measured via scale
Timepoint [11] 351242 0
Baseline and week 8
Secondary outcome [12] 351243 0
waist circumference measured by tape measure
Timepoint [12] 351243 0
Baseline and week 8
Secondary outcome [13] 351244 0
muscle fatigue and recovery measured by lactate dehydrogenase via blood test
Timepoint [13] 351244 0
baseline and week 8
Secondary outcome [14] 351245 0
liver enzymes AST, ALT and GGT measured by blood test
Timepoint [14] 351245 0
Baseline and week 8
Secondary outcome [15] 351248 0
Kidney function measured by eGFR via blood test
Timepoint [15] 351248 0
Baseline and week 8
Secondary outcome [16] 351249 0
Testosterone measured by blood test
Timepoint [16] 351249 0
Baseline and week 8
Secondary outcome [17] 351250 0
Inflammation C-reactive protein measured by blood test
Timepoint [17] 351250 0
Baseline and week 8
Secondary outcome [18] 351251 0
blood glucose measured via blood test
Timepoint [18] 351251 0
Baseline and week 8
Secondary outcome [19] 351252 0
Insulin measured by blood test
Timepoint [19] 351252 0
Baseline and week 8
Secondary outcome [20] 351253 0
Homocysteine measured by blood test
Timepoint [20] 351253 0
Baseline and week 8
Secondary outcome [21] 351254 0
full blood count measured by blood test
Timepoint [21] 351254 0
Baseline and week 8
Secondary outcome [22] 351255 0
glutathione measured by blood test
Timepoint [22] 351255 0
Baseline and week 8
Secondary outcome [23] 351256 0
reactive oxygen species measured by blood test
Timepoint [23] 351256 0
Baseline and week 8
Secondary outcome [24] 351257 0
malonyldialdehyde measured by blood test
Timepoint [24] 351257 0
Baseline and week 8

Eligibility
Key inclusion criteria
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 taking a form of contraception
Minimum age
25 Years
Maximum age
45 Years
Gender
Both males and females
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
Pregnant
Not currently taking a form of contraception
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 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
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] 300530 0
Commercial sector/Industry
Name [1] 300530 0
Pharmako Biotechnologies Pty Ltd
Address [1] 300530 0
Campbell Ave Cromer
NSW 2099 AUS
Country [1] 300530 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
RDC Global Pty Ltd
Address
3B/76 Doggett Street
Newstead QLD 4006
Country
Australia
Secondary sponsor category [1] 300007 0
Commercial sector/Industry
Name [1] 300007 0
Gencor Pacific
Address [1] 300007 0
21E, Elegance Court Discovery Bay Lantau Island Hong Kong, Hong Kong
Country [1] 300007 0
Hong Kong

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301318 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 301318 0
129 Glen Osmond Road Eastwood South Australia 5063
Ethics committee country [1] 301318 0
Australia
Date submitted for ethics approval [1] 301318 0
19/06/2018
Approval date [1] 301318 0
07/09/2018
Ethics approval number [1] 301318 0

Summary
Brief summary
This is a commercial study, to assess the effectiveness and dose response of Testofen on muscle strength, endurance and stress markers in exercising females.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86618 0
Dr David Briskey
Address 86618 0
RDC Global Pty Ltd
3B/76 Doggett St
Newstead, QLD, 4006
Country 86618 0
Australia
Phone 86618 0
+61 421 784 077
Fax 86618 0
Email 86618 0
d.briskey@uq.edu.au
Contact person for public queries
Name 86619 0
Ms Amanda Rao
Address 86619 0
RDC Global Pty Ltd
3B/76 Doggett Street
Newstead, QLD, 4006
Country 86619 0
Australia
Phone 86619 0
+61 414 488 559
Fax 86619 0
Email 86619 0
amanda@rdcglobal.com.au
Contact person for scientific queries
Name 86620 0
Ms Amanda Rao
Address 86620 0
RDC Global Pty Ltd
3B/76 Doggett Street
Newstead, QLD, 4006
Country 86620 0
Australia
Phone 86620 0
+61 414 488 559
Fax 86620 0
Email 86620 0
amanda@rdcglobal.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No IPD will be shared
What supporting documents are/will be available?
Study protocol
Clinical study report
Ethical approval
Summary results
Not applicable