Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001511729
Ethics application status
Approved
Date submitted
24/11/2022
Date registered
5/12/2022
Date last updated
19/01/2024
Date data sharing statement initially provided
5/12/2022
Date results information initially provided
19/01/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
An Assessment of the Safety and Efficacy of IDM01 capsules on General Fatigue and Cognitive Performance in Recreationally Active Adults
Scientific title
An Assessment of the Safety and Efficacy of IDM01 capsules on General Fatigue and Cognitive Performance in Recreationally Active Adults: A Prospective, Interventional, Double-Blind, Placebo-Controlled Parallel Arm Clinical Study.
Secondary ID [1] 308113 0
None
Universal Trial Number (UTN)
U1111-1283-5353
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fatigue 327818 0
Cognitive performance 327819 0
Condition category
Condition code
Alternative and Complementary Medicine 324892 324892 0 0
Herbal remedies
Mental Health 325401 325401 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Fenugreek extract (IDM01) (1 capsule daily taken orally, one hour after waking with or without food, delivering 500 mg a day for 8 weeks). Adherence to capsule intake will be measured by capsule return at weeks 4 and 8.

At baseline, week 4, and week 8, participants will ride on an exercise bike at 70 to 80% of their maximum heart rate (220 minus the participant's age) for 45 minutes. A heart rate monitor strap will be used to monitor participants' heart rates, which will be monitored by a researcher.
Intervention code [1] 324565 0
Treatment: Other
Comparator / control treatment
A matching placebo in terms of taste and appearance and containing all ingredients except the active ingredient (IDM01 Fenugreek extract)
Control group
Placebo

Outcomes
Primary outcome [1] 332697 0
Multidimensional Fatigue Symptom Inventory (Short Form) - Total score
Timepoint [1] 332697 0
Day 0, week 4, and 8 (primary endpoint) post-intervention commencement
Secondary outcome [1] 414392 0
Multidimensional Fatigue Symptom Inventory (Short Form) - General fatigue score
Timepoint [1] 414392 0
Day 0, week 4, and 8 post-intervention commencement
Secondary outcome [2] 414393 0
Multidimensional Fatigue Symptom Inventory (Short Form) - Physical fatigue score
Timepoint [2] 414393 0
Day 0, week 4, and 8 post-intervention commencement
Secondary outcome [3] 414394 0
Multidimensional Fatigue Symptom Inventory (Short Form) - Emotional fatigue score
Timepoint [3] 414394 0
Day 0, week 4, and 8 post-intervention commencement
Secondary outcome [4] 414395 0
Multidimensional Fatigue Symptom Inventory (Short Form) - Mental Fatigue score
Timepoint [4] 414395 0
Day 0, week 4, and 8 post-intervention commencement
Secondary outcome [5] 414396 0
Multidimensional Fatigue Symptom Inventory (Short Form) - Vigour score
Timepoint [5] 414396 0
Day 0, week 4, and 8 post-intervention commencement
Secondary outcome [6] 414397 0
Changes in perceived exercise exertion using the Borg Category-Ratio-10 rating
Timepoint [6] 414397 0
Day 0, week 4, and 8 post-intervention commencement. At each time point, assessments will be administered immediately after an exhaustive exercise task.
Secondary outcome [7] 414399 0
Changes in alertness using the Visual Analog Mood Scale - Alertness Score
Timepoint [7] 414399 0
Day 0, week 4, and 8 post-intervention commencement. At each time point, assessments will be administered: (1) immediately before the exhaustive exercise task, (2) immediately after the exhaustive exercise task, (3) 15 minutes after the exhaustive exercise task, and (4) immediately after computerised cognitive testing.
Secondary outcome [8] 414400 0
Changes in stress using the Visual Analog Mood Scale - Stress Score
Timepoint [8] 414400 0
Day 0, week 4, and 8 post-intervention commencement. At each time point, assessments will be administered: (1) immediately before the exhaustive exercise task, (2) immediately after the exhaustive exercise task, (3) 15 minutes after the exhaustive exercise task, and (4) immediately after computerised cognitive testing.
Secondary outcome [9] 414401 0
Changes in mood using the Visual Analog Mood Scale - Tranquility Score
Timepoint [9] 414401 0
Day 0, week 4, and 8 post-intervention commencement. At each time point, assessments will be administered: (1) immediately before the exhaustive exercise task, (2) immediately after the exhaustive exercise task, (3) 15 minutes after the exhaustive exercise task, and (4) immediately after computerised cognitive testing.
Secondary outcome [10] 414402 0
Changes in the desire to exercise using the Cravings for Rest and Volitional Energy Expenditure - Move Score
Timepoint [10] 414402 0
Day 0, week 4, and 8 post-intervention commencement. At each time point, assessments will be administered: (1) immediately before the exhaustive exercise task, (2) immediately after the exhaustive exercise task, (3) 15 minutes after the exhaustive exercise task, and (4) immediately after computerised cognitive testing.
Secondary outcome [11] 414403 0
Changes in the desire to rest using the Cravings for Rest and Volitional Energy Expenditure - Rest Score
Timepoint [11] 414403 0
Day 0, week 4, and 8 post-intervention commencement. At each time point, assessments will be administered: (1) immediately before the exhaustive exercise task, (2) immediately after the exhaustive exercise task, (3) 15 minutes after the exhaustive exercise task, and (4) immediately after computerised cognitive testing.
Secondary outcome [12] 414404 0
Changes in attention and cognitive performance as measured by the Computerised Mental Performance Assessment System (COMPASS)
Timepoint [12] 414404 0
Day 0, week 4, and 8 post-intervention commencement
Secondary outcome [13] 414405 0
Changes in hair cortisol concentration
Timepoint [13] 414405 0
Day 0 and 8 post-intervention commencement
Secondary outcome [14] 416362 0
Changes in blood liver function profile (safety measure)
Timepoint [14] 416362 0
Day 0 and 8 post-intervention commencement
Secondary outcome [15] 416363 0
Changes in full blood count (safety measure)
Timepoint [15] 416363 0
Day 0 and 8 post-intervention commencement
Secondary outcome [16] 416364 0
Changes in renal function blood test (safety measure)
Timepoint [16] 416364 0
Day 0 and 8 post-intervention commencement
Secondary outcome [17] 416365 0
Changes in blood lipid profile (safety measure)
Timepoint [17] 416365 0
Day 0 and 8 post-intervention commencement

Eligibility
Key inclusion criteria
1) Males and females between the ages of 18 and 50 years.
2) Engaging in regular resistance exercise for longer than 6 months and between 3 and 5 times a week.
3) BMI between 18.5 and 30 kg/m2.
4) Normal dietary habits (no medically prescribed diet, no slimming diet, no vegan or macrobiotic diet)
5) Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial.
6) Non-smoker.
7) Willing to maintain current diet, exercise, and supplement regimen during the study period.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) History of infection in the month prior to the study
2) Any significant surgeries over the last year
3) Clinically significant acute or chronic inflammation, or connective tissue disease or arthritis
4) Suffering from recently diagnosed or unmanaged medical conditions including but not limited to diabetes, hyper/hypotension, cardiovascular disease, gallbladder disease, autoimmune disease, endocrine disease, or cancer/ malignancy
5) Diagnosis of a psychiatric disease (other than mild-to-moderate depression or anxiety) and/or neurological condition/ disease (e.g., Parkinson’s, Alzheimer’s disease, intracranial haemorrhage, head or brain injury)
6) Suffering from insomnia or engaged in night-shift employment and unable to have a normal night’s sleep
7) Currently taking (or in the previous 3 months) the following medications and/or supplements: coumadin (Warfarin), heparin, dalteparin, enoxaparin or other anticoagulation therapy
8) Change in medication in the last 3 months or an expectation to change during the study duration
9) Alcohol intake greater than 14 standard drinks (12.5ml of pure alcohol) per week
10) Current or 12-month history of illicit drug abuse
11) Consumption of more than 3 cups of coffee a day (or another equivalent caffeinated beverage)
12) Intake of supplements containing fenugreek
13) Intake of any other dietary, herbal or pharmaceutical medications with significant stimulation on the central nervous system (e.g., caffeinated supplements or stimulant medications)
14) Pregnant women, women who are breastfeeding, or women who intend to fall pregnant.
15) Allergic to any of the ingredients in active or placebo formula
16) Have participated in any other clinical trial during the past 3 months
17) Any condition that in the opinion of the investigator makes the subject unsuitable for inclusion

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)
Allocation is concealed through the use of numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation using a randomisation table created by computer 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
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on a previous assessing the safety and efficacy of IDM01 on fatigue recovery and perception of fatigue in healthy adults, some parameters such as energy levels, fatigue levels and feelings of alertness showed statistically significant improvements in the active group compared to the placebo. Using the statistics for these parameters, the effect size for energy level was 0.46, and for fatigue level was 0.48. In this previous study, a daily dose of 360 mg of IDM01 was administered; however, in this study, we will be administering a daily dose of 500 mg. Therefore, a slightly larger medium effect size of 0.5 has been predicted. Considering a 10% loss to follow-up, a sample of 58 participants will be needed per group (total: 116) to find a statistically significant effect at an alpha 0.05 level.

If data is normalised, a repeated measure analysis of covariances (ANCOVA) will be conducted, or if data is not normalised appropriate non-parametric tests will be used to assess between-group differences in changes in the outcome variables over time.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/01/2023
Actual
30/01/2023
Date of last participant enrolment
Anticipated
27/10/2023
Actual
6/09/2023
Date of last data collection
Anticipated
22/12/2023
Actual
7/11/2023
Sample size
Target
116
Accrual to date
Final
120
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 312368 0
Commercial sector/Industry
Name [1] 312368 0
Indus Biotech Ltd
Country [1] 312368 0
India
Primary sponsor type
Commercial sector/Industry
Name
Clinical Research Australia
Address
38 Arnisdale Road Duncraig WA 6023
Country
Australia
Secondary sponsor category [1] 313933 0
None
Name [1] 313933 0
Address [1] 313933 0
Country [1] 313933 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311728 0
National Institute of Integrative Medicine (NIIM) Human Research Ethics Committee
Ethics committee address [1] 311728 0
11-23 Burwood Rd Hawthorn VIC 3122
Ethics committee country [1] 311728 0
Australia
Date submitted for ethics approval [1] 311728 0
12/09/2022
Approval date [1] 311728 0
28/11/2022
Ethics approval number [1] 311728 0
0111E_2022

Summary
Brief summary
In this randomised, double-blind, placebo-controlled study, 116 recreationally active adults will be randomly assigned to receive capsules containing either a fenugreek extract (IDM01) (500 mg once daily) or a placebo for 8 weeks. We will assess changes in self-perceived fatigue. Moreover, participants will complete an exhaustive aerobic exercise task at baseline, week 4 and week 8, and we will examine group differences in self-reported exhaustion, motivational states to exercise, and mood before and after the exercise task. Will we also examine changes in attention, vigilance and concentration after this exercise procedure using computer-based cognitive tasks.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122154 0
Dr Adrian Lopresti
Address 122154 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 122154 0
Australia
Phone 122154 0
+61 08 9448 7376
Fax 122154 0
Email 122154 0
adrian@clinicalresearch.com.au
Contact person for public queries
Name 122155 0
Dr Adrian Lopresti
Address 122155 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 122155 0
Australia
Phone 122155 0
+61 08 9448 7376
Fax 122155 0
Email 122155 0
adrian@clinicalresearch.com.au
Contact person for scientific queries
Name 122156 0
Dr Adrian Lopresti
Address 122156 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 122156 0
Australia
Phone 122156 0
+61 08 9448 7376
Fax 122156 0
Email 122156 0
adrian@clinicalresearch.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
Not approved by HREC


What supporting documents are/will be available?

No Supporting Document Provided



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.