None listed
Conditions
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.
Interventions
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 resea
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.
Sponsors
Clinical Research Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Outcome results
None listed