None listed
Conditions
Brief summary
In this randomised, double-blind, placebo-controlled study, 80 working adults experiencing high stress and fatigue will be randomly assigned to receive tablets containing either a saffron extract (affron) (14mg twice daily) or a placebo for 8 weeks. We will assess changes in stress, anxiety, sleep, and energy using self-report questionnaires. Changes in blood markers associated with inflammation (tumour necrosis factor – a and interleukin-4), and salivary concentrations of hormones associated with stress and sleep (cortisol and melatonin) will be assessed over time. Changes in heart rate variability, which provides a measure of overall health, will also be assessed over time.
Interventions
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.
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
18 Years to 65 Years
Healthy volunteers
No
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
Outcome results
None listed