An Assessment of the Safety and Efficacy of IDM01 capsules on General Fatigue and Cognitive Performance in Recreationally Active Adults

Not Applicable

Completed

• Conditions: Fatigue; Cognitive performance; Alternative and Complementary Medicine - Herbal remedies; Mental Health - Studies of normal psychology, cognitive function and behaviour

• Registration Number: ACTRN12622001511729
• Lead Sponsor: Clinical Research Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-12-05
• Study Completion: 2023-11-07
• Last Update Posted: 29 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

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.

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Multidimensional Fatigue Symptom Inventory (Short Form) - Total score [ Day 0, week 4, and 8 (primary endpoint) post-intervention commencement<br>]