ARE YOU FEELING DOWN OR SAD?

Volunteers are needed to examine the effects of the natural spice saffron on low mood/ depressive symptoms in adults

This is a registered clinical trial with the Australian and New Zealand Clinical Trials Registry (Link to Registry Webpage)

 Check to see if you may be eligible

About this study

Saffron is a dietary spice that has been shown in some studies to improve mood, overall wellbeing, and sleep quality. In this study, we are interested in further examining its effects on adults aged 18 to 70 years experiencing mild-to-moderate depressive symptoms.

PLEASE NOTE: No travel is required for this study, as all questionnaires are completed online.

There is no cost for participating in this study. To compensate you for your time, you will be given a $100 Coles group gift voucher when you complete the study.

If you are aged between 18 and 70 years and are experiencing mild-to-moderate depressive symptoms, we are inviting you to participate in this randomised, controlled study.

What does participating in this study involve?

Eligible participants will be RANDOMLY allocated into ONE of TWO treatment conditions:

  1. Daily intake of tablets containing a saffron extract, or
  2. Daily intake of placebo (fake) tablets

This 12-week study consists of the following:

  1. Participate in a 15-minute phone interview to discuss the study and assess your eligibility to participate
  2. Take the tablets for 12 weeks (1 tablet twice daily, containing either placebo or saffron).
  3. Complete online questionnaires comprising the following: (1) a brief questionnaire every 2 days which takes less than 1 minute to complete, and (2) a more comprehensive questionnaire every 4 weeks which takes 15 to 20 minutes to complete.

Please Note: All participants will be provided with a FREE 12-week supply of saffron tablets when they complete the study

You can download the full STUDY INFORMATION SHEET by clicking on the button at the bottom of this webpage.

Click on the image below to view the study design and requirements. 

What is the criteria for participating in this study?

To be INCLUDED in the study, the following inclusion criteria must be met:

  1. You are aged between 18 to 70 years
  2. You have mild-to-moderate severity depressive symptoms as assessed by a validated questionnaire
  3. You are a non-smoker
  4. You have a body mass index (BMI) between 18 and 35 kg/m2
  5. You have no plan to commence any new treatments over the study period
  6. You are willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial.

If any of the exclusion criteria below are met, you will not be suitable for participation in this study:

  1. In the last 12 months you have received a diagnosis of a psychiatric disorder by a health professional
  2. You are currently receiving regular psychological therapy/ counselling
  3. You are currently experiencing a severe life stressor (e.g., work, finances, relationship, health) that significantly impacts on your daily function and activity
  4. You suffer from a recently diagnosed or unmanaged medical condition including but not limited to: diabetes, hyper/hypotension, cardiovascular disease, gallbladder disease, autoimmune disease, endocrine disease, or cancer/ malignancy
  5. You have a neurological condition/ disease including but not limited to Parkinson’s or Alzheimer’s disease
  6. You regularly take medications such as anticonvulsants, benzodiazepines, opioids, corticosteroids, or immunosuppressants.
  7. You have changed your medication (dose or type) in the last 3 months or you expect to change it during the study
  8. In the last 3 months, you have commenced or changed your dose of nutritional and/or herbal supplements that may impact on treatment outcome
  9. You currently take supplements containing saffron
  10. You drink more than 14 standard servings of alcohol per week
  11. You currently (or in the last 12 months) have a problem with the use of illicit drugs
  12. You plan on making major lifestyle change in the next 3 months
  13. You are pregnant, breastfeeding, or intend to fall pregnant in the next 3 months
  14. You have had a major surgery in the last 12 months
  15. You have participated in another clinical trial in the last 3 months

Has this study received ethics approval?

This study has been approved by the National Institute of Integrative Medicine (NIIM) Ethics Committee (Reference number: 0134E_2023)

How can I apply for this study?

If you are interested in participating in this study, click on the button below to complete the initial screening questionnaire. This questionnaire will take 10 minutes to complete and helps us assess your eligibility to participate in this study.

Please Note: All answers are confidential and will only be seen by study investigators. If you are not eligible to participate in this study, your records will be deleted immediately

Please Note: All answers are confidential and will only be seen by study investigators. If you are not eligible to participate in this study, your records will be deleted immediately

 Complete Initial Screening Questionnaire
Download the FULL study Information Sheet

If you are interested in participating in this study, click on the button below to complete the initial screening questionnaire. This questionnaire will take 10 minutes to complete and helps us assess your eligibility for the study.

Please Note: All answers are confidential and will only be seen by study investigators. If you are not eligible to participate in this study, your records will be deleted immediately

 COMPLETE INITIAL SCREENING QUESTIONNAIRE

Are you interested in participating in a study?

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