None listed
Conditions
Brief summary
In this randomised, double-blind, placebo-controlled study, 200 adults aged 18 to 70 years with self-reported low mood will be randomly assigned to receive 14mg twice daily of a saffron extract (affron) or a placebo for 12 weeks. Changes in mood, sleep, and quality of life through the administration of validated self-report questionnaires will be assessed over time.
Interventions
Saffron extract (affron) (1 tablet taken orally, twice daily, with or without food, delivering 28 mg a day for 12 weeks). Adherence to tablet intake will be measured by a daily record of tablet intake using a phone application and a tablet count by the participants at week 12.
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. Adults (male and female) aged between 18 to 70 years 2. Currently experiencing low mood as demonstrated by a score of 10 to 20 at screening on the Depression, Anxiety, and Stress Scale -21 (DASS-21) depression subscale. 3. Non-smoker 4. BMI between 18 and 35 kg/m2 5. No plan to commence new treatments over the study period 6. Understand, willing and able to comply with all study procedures 7. Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial.
Exclusion criteria
1. In the last 12 months have received a diagnosis of a psychiatric disorder by a health professional. 2. Currently receiving regular psychological therapy/ counselling 3. Currently experiencing a severe life stressor (e.g., work, finances, relationship, health) that significantly impacts on daily function and activity 4. Suffering from recently diagnosed or unmanaged medical conditions including but not limited to: diabetes, hyper/hypotension, cardiovascular disease, gallbladder disease, autoimmune disease, endocrine disease, or cancer/ malignancy 5. Have a neurological condition/ disease including but not limited to Parkinson’s or Alzheimer’s disease 6. Regular medication intake including but not limited to anticonvulsants, benzodiazepines, opioids, corticosteroids, or immunosuppressants. 7. Change in medication in the last 3 months or an expectation to change during the study duration 8. In the last 3 months, commenced or changed the dose of nutritional and/or herbal supplements that may impact on the treatment outcome 9. Currently taking supplements containing saffron 10. Alcohol intake greater than 14 standard drinks per week 11. Current or 12-month history of illicit drug abuse 12. Planned major lifestyle change in the next 3 months 13. Pregnant women, women who are breastfeeding, or women who intend to fall pregnant during the study period 14. Any significant surgeries over the last year 15. Participation in any other clinical trial in the last 3 months
Outcome results
None listed