None listed
Conditions
Brief summary
In this randomised, double-blind, placebo-controlled study, 120 adults who are currently experiencing unsatisfactory sleep will be randomly assigned to receive tablets containing either a high-dose saffron extract (28mg a day), low-dose saffron extract (14mg a day), or placebo for 28 days.. We will assess change in sleep quality, quality of life, and mood via several validated self-report measures (to be completed at various time points throughout the study). We will also examine changes in evening salivary concentrations of cortisol and melatonin.
Interventions
Condition 1: Placebo tablets (1 tablet taken in the evening, 1 hour before bedtime, for 4 weeks)
Condition 2: Saffron extract (affron) (1 tablet taken in the evening, 1 hour before bedtime, delivering 28mg, for 4 weeks)
Condition 3: Saffron extract (affron) (1 tablet taken in the evening, 1 hour before bedtime, delivering 14mg, for 4 weeks)
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, Investigator, Outcomes Assessor)
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 poor sleep lasting longer than 4 weeks 3. Non-smoker 4. BMI between 20 and 35 5. Typical bedtime between 9 p.m. and 12 a.m. 6. 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 a sleep disorder other than moderate insomnia (e.g, sleep apnoea, restless leg syndrome, periodic limb movement disorder) 3. Suffer from mental health disorder other than mild depressive or anxiety symptoms as measured by the Patient Health Questionnaire (PHQ-4) 4. Coffee intake greater than 3 cups a day (or equivalent caffeine intake from other caffeinated drinks e.g., tea, energy drinks) 5. Alcohol consumption > 14 standard drinks per week 6. Experiencing external factors that may affect sleep patterns (e.g., infant/children regularly wakening, excess noise, a snoring partner, pain condition) 7. Currently receiving non-pharmacological treatment of sleep disorders (e.g., cognitive behavioural therapy, relaxation therapy) 8. Current or 12-month history of illicit drug abuse 9. Pregnant women, women who are breastfeeding, or women who intended to fall pregnant. 10. 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 11. 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), and cancer/malignancy 12. Current use of pharmaceutical medications that may affect sleep quality 13. Current use of supplements that may affect sleep 14. Currently taking saffron supplements
Outcome results
None listed