None listed
Conditions
Brief summary
In this randomised, double-blind, placebo-controlled study, 80 women aged 50 to 70 years experiencing comorbid depressive symptoms and sleep disturbances will be randomly assigned to receive a saffron extract (14mg twice daily) or a placebo for 12 weeks. Changes in depressive symptoms and sleep quality will be examined over time. Moreover, changes in self-evaluations of physical appearance and self-esteem will be examined. Using photos of participants, a skin age application using AI technology will also be used to evaluate changes in facial skin age over time. It is hypothesised that compared to the placebo, saffron supplementation will be associated with greater reductions in depressive symptoms, sleep disturbances, self-esteem and self-evaluations of physical appearance. Moreover, a reduction in facial skin age is also predicted.
Interventions
Saffron extract (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
50 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Adults (female) aged between 50 to 70 years 2. Currently experiencing low mood as demonstrated by a score of 10 to 27 on the Depression, Anxiety, and Stress Scale -21 (DASS-21) depression subscale. 3. A score greater than 75th Percentile (T-score greater than or equal to 56.5) on the PROMIS Sleep Disturbance scale 4. Non-smoker 5. BMI between 18 and 35 kg/m2 6. No plan to commence new treatments for mood, sleep, or skin quality over the study period 7. Understand, willing and able to comply with all study procedures 8. Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial.
Exclusion criteria
1. Currently receiving regular psychological therapy/ counselling 2. Suffering from recently diagnosed or unmanaged medical conditions including but not limited to diabetes, hypertension, cardiovascular disease, gallbladder disease, autoimmune disease, endocrine disease, or cancer/ malignancy 3. Have a psychiatric disorder (other than mild-to-moderate depression and/or anxiety), or a neurological condition/ disease including but not limited to Parkinson’s or Alzheimer’s disease 4. Regular medication intake including but not limited to anticonvulsants, benzodiazepines, opioids, corticosteroids, or immunosuppressants. 5. Change in medication in the last 3 months or an expectation to change during the study duration 6. In the last 3 months, commenced or changed the dose of nutritional and/or herbal supplements that may impact treatment outcome 7. Currently taking supplements containing saffron 8. Alcohol intake greater than 14 standard drinks per week 9. Current or 12-month history of illicit drug abuse 10. Planned major lifestyle change in the next 3 months 11. Pregnant women, women who are breastfeeding, or women who intend to fall pregnant during the study period 12. Any significant surgeries that continue to affect daily function over the last year 13. Participation in any other clinical trial in the last month
Outcome results
None listed