None listed
Conditions
Brief summary
In this randomised, double-blind, placebo-controlled study, 50 adults who are currently experiencing unsatisfactory sleep will be randomly assigned to receive tablets containing either a saffron extract (28mg a day) or placebo for 28 days. We will assess change in sleep habits, sleep quality, severity of insomnia, restorative effects of sleep, and depression, anxiety, and stress scores via several validated self-report measures (to be completed at various time points throughout the study).
Interventions
Two tablets containing 14mg of a proprietary saffron extract (affron) (total daily dose of 28mg) will be consumed twice daily for 28 days (subsequent to 2 days of baseline monitoring) by adults aged between 18 and 70 years. Adherence to tablet intake will be monitored through tablet 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)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Healthy adults (male and female) between 18 and 70 2. Self-reported symptoms of unsatisfactory sleep lasting greater than 4 weeks (as measured by a score between 8 and 21 on the Insomnia Sleep Index) 3. Medication-free for at least 4 weeks apart from the contraceptive pill and no more than once a week use of pain-relieving medications. 4. Non-smoker 5. BMI between 20 and 30 6. Typical bedtime between 9 p.m. and 12 a.m. 7. Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial.
Exclusion criteria
1. Employed in night shift work or rotational shift work 2. Suffer from sleep disorder other than moderate insomnia (e.g, sleep apnoea, restless leg syndrome, periodic limb movement disorder) 3. Chronic sleep disturbance greater than 1 year 4. Suffer from mental health disorder (other than mild depressive or anxiety symptoms as measured by the Depression, Anxiety and Stress Scale-21) 5. Coffee intake greater than 3 cups a day (or equivalent caffeine intake from other caffeinated drinks e.g., tea, energy drinks) 6. Alcohol consumption > 14 standard drinks per week 7. Experiencing external factors that may affect sleep patterns (e.g., infant/children regularly awakening, excess noise, snoring partner, pain condition) 8. Currently receiving non-pharmacological treatment of sleep disorders (e.g., cognitive behavioural therapy, relaxation therapy) 9. Current or 12-month history of illicit drug abuse 10. Pregnant women, women who are breastfeeding or women who intended to fall pregnant. 11. Suffering from medical conditions including but not limited to: diabetes, hyper/hypotension, cardiovascular disease, gastrointestinal disease requiring regular use of medications, gallbladder disease/gallstones/biliary disease, endocrine disease, psychiatric disorder, and neurological disease (Parkinson’s, Alzheimer’s disease, intracranial haemorrhage, head or brain injury), acute or chronic pain affecting sleep 12. Current use of supplements that may affect sleep 13. Currently taking saffron supplements
Outcome results
None listed