None listed
Conditions
Brief summary
This is a randomised, double-blind, placebo-controlled study investigating the effects of the herb ashwagandha on cognition, sleep, and energy in children with parent-reported concerns in attention, memory, and concentration. In this 8-week, multi-national study comprising a total of 80 participants (40 participants recruited in Australia and 40 in India) participants will take two gummies a day containing 150mg 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 parent-report questionnaires that assess children’s mood, cognitive/executive function, fatigue, and sleep. It is hypothesised that, compared to the placebo, ashwagandha supplementation will be associated with greater improvements in cognitive function, sleep and energy levels.
Interventions
Ashwagandha extract (KSM-66) (1 gummy taken orally, twice daily with breakfast and dinner, delivering 300 mg a day for 8 weeks)
Adherence to gummy intake will be monitored through a mobile phone app and gummy 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
6 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
1. Parent-reported concerns in child’s attention, concentration, or memory 2. Child attends mainstream schooling and mainstream classing 3. Child is a healthy male or female aged between 6 and 12 years 4. Parent/legal guardian and child willing to provide a personally signed and dated informed consent indicating that they have been informed of all pertinent aspects of the trial. 5. Child willing and able to take prescribed supplements 6. Child’s BMI between 18 and 30 kg/m2 7. There is no plan for the child to commence new treatments over the study period 8. Parent and child fluent in English
Exclusion criteria
1. Current or 12-month history in a child of any psychiatric disorder (including ADHD) 2. Child is currently taking pharmaceutical medications expected to affect behaviour and learning. 3. Current or history of clinically significant chronic medical condition in the child including but not limited to cardiovascular disease, organic brain disorder, seizure, or diabetes. 4. Any diagnosed learning disorder in the child 5. Child is experiencing exceptional social/family stressors (e.g., serious illness in the family, recent parental separation, etc). 6. Child is currently taking ashwagandha or other supplements that may affect cognition or sleep 7. Child has had a significant surgery over the last year
Outcome results
None listed