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

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2022
INTERVENTION: Saffron extract (affron) (1 tablet taken orally, twice daily with or without food, delivering 28 mg a day for 8 weeks). Adherence to tablet intake will be measured by a pill count by the participant at week 4 and tablet return at the end of the study. CONDITION: Alternative and Complementary Medicine ‐ Herbal remedies High stress;Fatigue;Inflammation; ; High stress ; Fatigue ; Inflammation Inflammatory and Immune System ‐ Other inflammatory or immune system disorders Mental Health ‐ Other mental health disorders PRIMARY OUTCOME: Change in Perceived Stress Scale [Day 0, weeks 4 and 8 (primary endpoint) post‐intervention commencement] SECONDARY OUTCOME: Change in blood concentrations of interleukin 6[Day 0 and weeks 8 post‐intervention commencement] Change in Athens Insomnia Scale Score[Day 0, weeks 2, 4, 6 and 8 post‐intervention commencement] Change in evening salivary concentrations of melatonin[Day 0 and weeks 8 post‐intervention commencement] Change in Anxiety Symptoms Questionnaire Score[Day 0, weeks 2, 4, 6 and 8 post‐intervention commencement] Change in blood concentrations of tumour necrosis factor ‐ alpha[Day 0 and weeks 8 post‐intervention commencement] Change in Copenhagen Burnout Inventory personal burnout subscale score[Day 0, weeks 2, 4, 6 and 8 post‐intervention commencement] Change in Copenhagen Burnout Inventory work‐related burnout subscale score[Day 0, weeks 2, 4, 6 and 8 post‐intervention commencement] Change in heart rate variability, assessed by electrocardiogram (ECG) measurements using a heart rate monitor strap (Polar H10). After a 5‐minute rest in a silent environment, ECG measurements will be performed for 5 minutes while the participant is in a seated position. ; [Day 0 and weeks 8 post‐intervention commencement] Change in evening salivary concentrations of cortisol[Day 0 and weeks 8 post‐intervention commencement] 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.
Epistemonikos ID: 53edede6f8a666110f5953084cf94f61e609aee1
First added on: Aug 25, 2024