Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001356257
Ethics application status
Approved
Date submitted
3/07/2018
Date registered
10/08/2018
Date last updated
20/10/2021
Date data sharing statement initially provided
15/10/2019
Date results information initially provided
20/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of 8 weeks of a Fenugreek extract supplementation in combination with exercise training on exercise capacity in healthy young males
Scientific title
The effects of 8 weeks of a Fenugreek extract supplementation in combination with exercise training on exercise capacity in healthy young males
Secondary ID [1] 295405 0
Nil known
Universal Trial Number (UTN)
Trial acronym
IND-EXE18
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Exercise capacity 308634 0
Condition category
Condition code
Physical Medicine / Rehabilitation 307580 307580 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The investigational product (Fenugreek) is an ARTG listed commercially available capsule-form herbal medicine containing a purified extract of Fenugreek seed extract.

Arm 1: Active treatment with 300mg/day split between 2 doses, one capsule taken in the morning and one capsule in the evening for 8 weeks.

Arm 2: Active treatment with 600mg/day split between 2 doses, one capsule taken in the morning and one capsule in the evening for 8 weeks.

Arm 3: Placebo taken for 8 weeks.


Adherence will be monitored by trial product container return and capsule count at the end of the study.

Participants will undertake a set exercise routine of running on a treadmill for between 35-50min 4 x weekly during weeks 1-3 and 5-7. Specifically the following regime will be prescribed:
Week 1: 35min duration running at 60-70% HRmax
Week 2: 35min duration running at 65-75% HRmax
Week 3: 40min duration running at 65-75% HRmax
Week 4: 40min duration running at 70-80% HRmax
Week 5: 45min duration running at 70-80% HRmax
Week 6: 45min duration running at 75-85% HRmax
Week 7: 50min duration running at 75-85% HRmax
Week 8: 50min duration running at 80-85% HRmax

During weeks 4 and 8, participants will be asked to undertake 3 x weekly exercise sessions instead of 4 and attend the study site for an exercise assessment which involves running on a treadmill. An exercise physiologist will be undertaking the exercise assessment and remaining sessions can be done at home or in the gym depending on personal preference and access to a treadmill. Participants will be asked to monitor their own activity through Strava (phone app) which the exercise physiologist can also see.
Intervention code [1] 301712 0
Treatment: Drugs
Comparator / control treatment
Arm 3: Placebo containing maltodextrin taken over 2 doses, one capsule in the morning and one capsule in the evening.
Control group
Placebo

Outcomes
Primary outcome [1] 306558 0
Time to reach exhaustion stage measured via graded treadmill test
Timepoint [1] 306558 0
Baseline, weeks 4 and 8 (primary endpoint) post commencement of intervention
Primary outcome [2] 306779 0
Time to reach exhaustion measured by wingate test
Timepoint [2] 306779 0
Baseline, weeks 4 and 8 (primary endpoint) post commencement of intervention
Secondary outcome [1] 348865 0
Muscle fatigue - change in fatigue score by validated fatigue scale questionnaire MSFI
Timepoint [1] 348865 0
Baseline, weeks 4 and 8 post commencement of intervention
Secondary outcome [2] 348868 0
Energy expenditure measured by change in metabolic equivalents measured via gas analysis during the VO2max test
Timepoint [2] 348868 0

Baseline, weeks 4 and 8 post commencement of intervention
Secondary outcome [3] 348869 0
Change in mental focus measured by blood and saliva cortisol test
Timepoint [3] 348869 0
baseline and week 8 post commencement of intervention
Secondary outcome [4] 348870 0
Quality of life measured by physical activity readiness questionnaire
Timepoint [4] 348870 0
Baseline, weeks 4 and 8 post commencement of intervention
Secondary outcome [5] 348871 0
Safety measured by the 'Gastrointestinal Tolerance Questionnaire'
Timepoint [5] 348871 0
baseline, weeks 4 and 8 post commencement of intervention
Secondary outcome [6] 349621 0
change in mental focus measured by Multidimensional
Fatigue Syndrome Inventory- Short Form( MFSI-SF) questionnaire
Timepoint [6] 349621 0
Baseline, weeks 4 and 8 post commencement of intervention
Secondary outcome [7] 349622 0
change in muscle fatigue score measured by VAS questionnaire
Timepoint [7] 349622 0

Baseline, weeks 4 and 8 post commencement of intervention
Secondary outcome [8] 349624 0
Energy expenditure measured by change in blood free fatty acids
Timepoint [8] 349624 0
Baseline and week 8 post commencement of intervention
Secondary outcome [9] 349625 0
Energy expenditure measured by change in fasting glucose blood test
Timepoint [9] 349625 0
Baseline and week 8 post commencement of intervention
Secondary outcome [10] 349906 0

Muscle fatigue - change in Wingate anaerobic power
Timepoint [10] 349906 0
Baseline, weeks 4 and 8 post commencement of intervention
Secondary outcome [11] 349907 0
Energy expenditure measured by Multidimensional
Fatigue Syndrome Inventory- Short Form( MFSI-SF) questionnaire
Timepoint [11] 349907 0
Baseline, weeks 4 and 8 post commencement of intervention
Secondary outcome [12] 349908 0
Quality of life measured by short form-36 questionnaire
Timepoint [12] 349908 0
Baseline, weeks 4 and 8 post commencement of intervention
Secondary outcome [13] 350518 0
Safety via a blood test measuring Liver enzyme GGT
Timepoint [13] 350518 0
Baseline and week 8
Secondary outcome [14] 350519 0
Safety - blood test measuring kidney function - creatine
Timepoint [14] 350519 0
Baseline and week 8
Secondary outcome [15] 350520 0
Safety via a blood test measuring Liver enzyme ALT
Timepoint [15] 350520 0
baseline and week 8
Secondary outcome [16] 350521 0
Safety via a blood test measuring Liver enzyme AST
Timepoint [16] 350521 0
Baseline and week 8
Secondary outcome [17] 350522 0
Safety via a blood test measuring albumin
Timepoint [17] 350522 0
Baseline and week 8
Secondary outcome [18] 350523 0
Safety - blood test measuring kidney function - eGFR
Timepoint [18] 350523 0
baseline and week 8
Secondary outcome [19] 350524 0
safety - blood test measuring sodium
Timepoint [19] 350524 0
Baseline and week 8
Secondary outcome [20] 350525 0
safety- blood test measuring potassium
Timepoint [20] 350525 0
Baseline and week 8
Secondary outcome [21] 352819 0
Waist hip ratio measured using a tape measure
Timepoint [21] 352819 0
Baseline and week 8
Secondary outcome [22] 352820 0
Waist circumference measured using a tape measure
Timepoint [22] 352820 0
Baseline and week 8
Secondary outcome [23] 352821 0
hip circumference measured using a tape measure
Timepoint [23] 352821 0
Baseline, and week 8
Secondary outcome [24] 352822 0
height measured using a stadiometer
Timepoint [24] 352822 0
Baseline and week 8
Secondary outcome [25] 352823 0
body weight using a scale
Timepoint [25] 352823 0
Baseline and week 8
Secondary outcome [26] 352824 0
Change in heart rate using a heart rate monitor
Timepoint [26] 352824 0
Baseline, weeks 4 and 8
Secondary outcome [27] 352825 0
Change in blood pressure using a blood pressure monitor
Timepoint [27] 352825 0
Baseline, weeks 4 and 8
Secondary outcome [28] 352826 0
Change in total running distance measured using a treadmill
Timepoint [28] 352826 0
Baseline, weeks 4 and 8
Secondary outcome [29] 352827 0
Change in total running time using a treadmill
Timepoint [29] 352827 0
Baseline, weeks 4 and 8
Secondary outcome [30] 352828 0
Change in respiratory exchange ratios during VO2max test
Timepoint [30] 352828 0
Baseline, weeks 4 and 8
Secondary outcome [31] 352829 0
Change in VO2 max during VO2max test
Timepoint [31] 352829 0
Baseline, weeks 4 and 8
Secondary outcome [32] 352830 0
Change in ventilatory threshold during VO2max test
Timepoint [32] 352830 0
Baseline, weeks 4 and 8

Eligibility
Key inclusion criteria
Males over 18-40 years
Normal dietary habits (no medically prescribed diet, no slimming diet, no vegan or macrobiotic diet)
Otherwise healthy, BMI 18.5-25 kg/m2
Able to provide informed consent
Agree not to change current diet and exercise program, or not to use other dietary supplements other than the test product during entire study period.
Exercising a minimum of 2 days per week
Minimum age
18 Years
Maximum age
40 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Unstable or serious illness (e.g. kidney, liver, GIT, heart conditions, diabetes, thyroid gland function Malignancy)
Malignancy or treatment for malignancy within the previous 2 years
Receiving/ prescribed coumadin (Warfarin), heparin, daltaparin, enoxaparin or other anticoagulation therapy
Active smokers, nicotine, alcohol, drug abuse
Chronic past and/or current alcohol use (>14 alcoholic drinks week)
Allergic to any of the ingredients in active or placebo formula
People with serious mood disorders (such as depression and bipolar disorder) will be excluded. The Hamilton Rating Scale for Depression could be used as a screening form to ensure that those with undiagnosed depression are not enrolled into the study
Those suffering from insomnia or have night-shift employment and unable to have a normal night’s sleep
People suffering any neurological disorders such as MS
Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
Participants who have participated in any other clinical trial during the past 3 months
Clinically significant acute or chronic inflammation, or connective tissue disease or arthritis
History of infection in the month prior to the study

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
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
Completed
Date of first participant enrolment
Anticipated
12/08/2018
Actual
12/08/2018
Date of last participant enrolment
Anticipated
Actual
16/04/2020
Date of last data collection
Anticipated
Actual
1/06/2020
Sample size
Target
150
Accrual to date
Final
153
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 299993 0
Commercial sector/Industry
Name [1] 299993 0
Indus Biotech
Country [1] 299993 0
India
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] 299377 0
None
Name [1] 299377 0
Address [1] 299377 0
Country [1] 299377 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300848 0
University of Queensland Human Research Ethics Committee
Ethics committee address [1] 300848 0
St Lucia QLD 4072
Ethics committee country [1] 300848 0
Australia
Date submitted for ethics approval [1] 300848 0
27/03/2018
Approval date [1] 300848 0
11/06/2018
Ethics approval number [1] 300848 0

Summary
Brief summary
Approximately 150 male participants aged between 18-40 years of age will be recruited from databases and public media outlets. Following preliminary screening via telephone, potential participants will attend the clinic for an information session and will be required to provide their consent for inclusion in the trial. Consenting participants will undergo a health assessment including lifestyle, current medications, physical assessment and medical history; this data will be used for the comprehensive screening and to provide contextual data for the study.

Once enrolled in the trial, participants will be randomly allocated to either the placebo comparator group (n=50) or one of two active intervention groups (n=50 per group). Height, weight, body composition, cardiovascular function, and treadmill exercise testing and questionnaires regarding gastrointestinal tolerance, score of fatigue, and quality of life will be assessed at enrolment. Within the week pre-treatment, participant’s blood will be collected for analysis of pre-treatment blood markers.

Participants will be asked to take the allocated product according to the dose prescribed. In addition, participants will be asked to undertake the training program consisting of aerobic training. Participants will complete 4 training sessions per week and undertake further assessment at weeks 4 and 8.

At the mid-point (week 4) participants will complete treadmill exercise testing, as well as having weight and waist circumference assessment.

At the completion of the study (week 8), an assessment identical to what was undertaken at baseline will be carried out.

At both time points (week 4 and 8) and as part of the assessment, participants will be interviewed and asked to provide details regarding any lifestyle changes (diet, exercise, medication) in addition to subjective changes in exercise, performance and any adverse effects (including change in libido and mood).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85022 0
Dr David Briskey
Address 85022 0
RDC Global Pty Ltd
3B/76 Doggett St, Newstead, QLD, 4006
Country 85022 0
Australia
Phone 85022 0
+61 421 784 077
Fax 85022 0
Email 85022 0
[email protected]
Contact person for public queries
Name 85023 0
Dr Dean Mills
Address 85023 0
University of Southern QLD
11 Salisbury Road
Ipswich Qld 4305
Australia
Country 85023 0
Australia
Phone 85023 0
+61 7 3812 6147
Fax 85023 0
Email 85023 0
[email protected]
Contact person for scientific queries
Name 85024 0
Dr Dean Mills
Address 85024 0
University of Southern QLD
11 Salisbury Road
Ipswich Qld 4305
Australia
Country 85024 0
Australia
Phone 85024 0
+61 7 3812 6147
Fax 85024 0
Email 85024 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5261Ethical approval    375491-(Uploaded-09-10-2019-17-47-22)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.