Effects of a saffron extract (affron) on adults experiencing mild-to-moderate stress and burnout

Not Applicable

Completed

• Conditions: High stress; Fatigue; Inflammation; Mental Health - Other mental health disorders; Alternative and Complementary Medicine - Herbal remedies; Inflammatory and Immune System - Other inflammatory or immune system disorders

• Registration Number: ACTRN12622000527763
• Lead Sponsor: Clinical Research Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-04-04
• Study Completion: 2022-12-23
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1)Healthy adults (male and female) 18 to 65 years
2)Engaged in paid work for at least 30 hours a week
3)Currently experiencing high stress (as determined by a Perceived Stress Scale score of 14 or more)
4)Currently experiencing low energy/ fatigue as determined by a rating of 5 or more on an 11-point numeric rating scale (0 = no fatigue; 5 = moderately fatigued; to 10 = extremely fatigued)
5)Non-smoker
6)BMI between 18 and 30 kg/m2
7)No plan to commence new treatments over the study period
8)Understand, willing and able to comply with all study procedures
9)Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial.

Exclusion Criteria

1)Suffering from recently diagnosed or unmanaged medical conditions including but not limited to: diabetes, hyper/hypotension, cardiovascular disease, a gastrointestinal disease requiring regular use of medications, gallbladder disease, autoimmune disease, endocrine disease, acute or chronic pain condition, or cancer/malignancy
2)Diagnosis of psychiatric or neurological conditions including but not limited to: any psychiatric disorder (other than mild-to-moderate depression and/or anxiety), neurological disease (Parkinson’s, Alzheimer’s disease, intracranial haemorrhage, head or brain injury),
3)Regular medication intake including but not limited to anticholinergics, anti-epileptics, acetylcholinesterase inhibitors, antihistamines, benzodiazepines, opioids, or corticosteroids.
4)Change in medication in the last 3 months or expectation to change during the study duration
5)Currently taking saffron supplements
6)In the last 6 months, commenced or changed dose of nutritional and/or herbal supplements that may impact on treatment outcome
7)Current or 12-month history of illicit drug abuse
8)Alcohol intake greater than 14 standard drinks per week
9)Participation in any other clinical trial in the last 3 months
10)Pregnant women, women who are breastfeeding or women who intend to fall pregnant.
11)Any significant surgeries over the last year
12)Overnight shift workers
13)Planned major lifestyle change in the next 3 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified