None listed
Conditions
Brief summary
This is a randomised, double-blind, placebo-controlled, multi-national study investigating the effects of the herb ashwagandha on cognition, energy, and mood in adults presenting with self-reported cognitive complaints and low energy. In this 8-week, study comprising a total of 80 participants (40 participants recruited in Australia and 40 in India) participants will take two capsules a day containing 300mg of ashwagandha or placebo. We will assess changes in cognitive performance through the completion of a computer-based test that assesses various cognitive skills (e.g., attention, working memory, and episodic memory), and self-report questionnaires that assess, mood, cognitive/executive function, and fatigue. It is hypothesised that, compared to the placebo, ashwagandha supplementation will be associated with greater improvements in cognitive function, mood, and energy levels.
Interventions
Ashwagandha extract (KSM-66) (1 capsule taken orally, twice daily with breakfast and dinner, delivering 600 mg a day for 8 weeks)
Adherence to capsule intake will be monitored through a mobile phone app and capsule return and count.
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
30 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Healthy adults (male and female) between 30 and 75 years 2. Residing in independent living accommodation 3. Subjective report of memory or attention problems by answering ‘yes’ to the following question: Do you have problems with your memory, attention, or concentration? 4. Subjective reports of fatigue/energy problems by answering ‘yes’ to the following question: Do you have problems with fatigue or energy? 5. Non-smoker 6. BMI between 18 and 30 kg/m2 7. No plan to commence new treatments over the study period 8. Understand, willing and able to comply with all study procedures 9. Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial.
Exclusion criteria
1. A score below the 5th percentile for age, education, and gender on the Telephone Interview for Cognitive Status (TICS-M) 2. Suffering from recently diagnosed or unmanaged medical conditions including but not limited to: diabetes, hyper/hypotension, cardiovascular disease, gastrointestinal disease requiring regular use of medications, gallbladder disease/gallstones/biliary disease, autoimmune disease, endocrine disease, acute or chronic pain condition 3. Diagnosis of medical or psychiatric conditions including but not limited to: psychiatric disorder (other than mild-to-moderate depression or anxiety), neurological disease (Parkinson’s, Alzheimer’s disease, intracranial haemorrhage, head or brain injury), or cancer/malignancy 4. History of stroke or seizures or head injury (with loss of consciousness). 5. Regular medication intake including anti-coagulant drugs, anti-cholinergics, acetylcholinesterase inhibitors, or steroid medications. 6. Change in medication in the last 3 months or expectation to change during the study duration 7. Current nutrient deficiencies including low iron or vitamin B12 concentrations 8. Taking vitamins or herbal supplements that are reasonably expected to influence study measures. 9. Current or 12-month history of illicit drug abuse 10. Alcohol intake greater than 14 standard drinks per week 11. Any significant surgeries over the last year
Outcome results
None listed