None listed
Conditions
Brief summary
In this randomised, double-blind, placebo-controlled study, 100 children aged 6 to 11 years experiencing low mood will be randomly assigned to receive a saffron extract (14mg twice daily) or a placebo for 6 weeks. Changes in mood (the primary objective) and sleep quality will be examined over time using child- and parent-report questionnaires. It is hypothesised that, compared to the placebo, saffron supplementation will lead to greater improvements in mood and sleep
Interventions
Saffron extract (1 chewable tablet taken orally, twice daily, with or without food, delivering 28 mg a day for 6weeks). Adherence to tablet intake will be measured by a daily record of tablet intake using a phone application and a tablet count by the parent at week 6.
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 11 Years
Healthy volunteers
No
Inclusion criteria
1. Males & females aged 6 to 11 years 2. Parent-reported emotional difficulties in the child as indicated by a score of 10 or higher on the Mood and Feelings Questionnaire (parent version) 3. Child attends mainstream schooling/ classes 4. Child has a BMI within the 10th and 90th percentile based on age-related norms 5. Child and parent/primary carer are able to provide voluntary, written, informed consent to participate in the study 6. Child and parent understand, are willing and able to comply with all study procedures 7. Child is willing and able to take the prescribed placebo/saffron supplement 8. Child lives with the reporting parent for at least 5 days a week
Exclusion criteria
1. Child has a known allergy to saffron or inactive ingredients included in the tablets 2. Child is currently receiving treatment for emotional or behaviour-related difficulties, or there is a plan to start a new treatment during the study period. 3. Child has a diagnosis of a sleep disorder, including but not limited to insomnia, night terrors, and/or sleepwalking 4. Child has a medical/physical condition that significantly affects daily function 5. Child has been diagnosed with a psychiatric condition that significantly affects daily function. 6. Child engages in self-harm behaviours or has suicidal ideation 7. Child has had any injury, surgery, or illness in the last 3 months that significantly affected his/her daily function 8. Child has been currently taking, or in the last 8 weeks, taken a pharmaceutical medication 9. Child has been currently taking, or in the last 8 weeks, taken a nutritional or herbal supplement that may affect the treatment outcomes 10. Any plan to commence a pharmaceutical medication or nutritional, or herbal supplement during the study period 11. Child is experiencing a significant family or lifestyle stressor that may impact his/her emotional function 12. A planned significant lifestyle, dietary or environmental change during the study period for the child and/or parent 13. Child has participated in a clinical research trial within 30 days prior to randomisation 14. Child has a significant learning or cognitive impairment 15. Any other condition which, in the Investigator’s opinion, may adversely affect the child’s and/or parent’s ability to complete the study or its measures or which may pose a significant risk to the child
Outcome results
None listed