An examination into the effects of a saffron extract (affron) on mood and general wellbeing in adults experiencing low mood: a randomised, double-blind, placebo-controlled trial

Not Applicable

Recruiting

• Conditions: ow mood; Anxiety; Sleep; Low mood; Mental Health - Depression; Mental Health - Anxiety; Mental Health - Other mental health disorders; Alternative and Complementary Medicine - Herbal remedies

• Registration Number: ACTRN12623001358639
• Lead Sponsor: Clinical Research Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-21
• Last Update Posted: 29 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ow mood[Depression, Anxiety, and Stress Scale - Depression Subscale Score Day 0 (pre-commencement of intervention), week 4, 8, and 12 (primary endpoint) post-intervention commencement]