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Trial registered on ANZCTR


Registration number
ACTRN12622000527763
Ethics application status
Approved
Date submitted
30/03/2022
Date registered
4/04/2022
Date last updated
14/02/2023
Date data sharing statement initially provided
4/04/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of a saffron extract (affron) on adults experiencing mild-to-moderate stress and burnout
Scientific title
Effects of a saffron extract (affron) on adults experiencing mild-to-moderate stress and burnout: a randomised, double-blind, placebo-controlled study
Secondary ID [1] 306810 0
None
Universal Trial Number (UTN)
U1111-1276-5780
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
High stress 325888 0
Fatigue 325889 0
Inflammation 325890 0
Condition category
Condition code
Mental Health 323196 323196 0 0
Other mental health disorders
Alternative and Complementary Medicine 323197 323197 0 0
Herbal remedies
Inflammatory and Immune System 323198 323198 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 323270 0
Treatment: Other
Comparator / control treatment
Placebo (containing cellulose) is matched to the saffron extract tablets in terms of taste and appearance but does not contain any of the active ingredients.
Control group
Placebo

Outcomes
Primary outcome [1] 330948 0
Change in Perceived Stress Scale
Timepoint [1] 330948 0
Day 0, weeks 4 and 8 (primary endpoint) post-intervention commencement
Secondary outcome [1] 408212 0
Change in Copenhagen Burnout Inventory personal burnout subscale score
Timepoint [1] 408212 0
Day 0, weeks 2, 4, 6 and 8 post-intervention commencement
Secondary outcome [2] 408213 0
Change in Copenhagen Burnout Inventory work-related burnout subscale score
Timepoint [2] 408213 0
Day 0, weeks 2, 4, 6 and 8 post-intervention commencement
Secondary outcome [3] 408214 0
Change in Anxiety Symptoms Questionnaire Score
Timepoint [3] 408214 0
Day 0, weeks 2, 4, 6 and 8 post-intervention commencement
Secondary outcome [4] 408215 0
Change in Athens Insomnia Scale Score
Timepoint [4] 408215 0
Day 0, weeks 2, 4, 6 and 8 post-intervention commencement
Secondary outcome [5] 408216 0
Change in evening salivary concentrations of cortisol
Timepoint [5] 408216 0
Day 0 and weeks 8 post-intervention commencement
Secondary outcome [6] 408217 0
Change in evening salivary concentrations of melatonin
Timepoint [6] 408217 0
Day 0 and weeks 8 post-intervention commencement
Secondary outcome [7] 408218 0
Change in blood concentrations of interleukin 6
Timepoint [7] 408218 0
Day 0 and weeks 8 post-intervention commencement
Secondary outcome [8] 408219 0
Change in blood concentrations of tumour necrosis factor - alpha
Timepoint [8] 408219 0
Day 0 and weeks 8 post-intervention commencement
Secondary outcome [9] 408220 0
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.
Timepoint [9] 408220 0
Day 0 and weeks 8 post-intervention commencement

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is concealed through the use of numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation using a randomisation table created by a computer software. This computer-generated randomisation structure will comprise 8 randomly permuted blocks, containing 10 participants per block.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on previous studies on saffron, we are predicting an effect size of 0.6 compared to placebo. Based on this, a sample size of 36 per group is required. This gives an 80% chance of finding an effect at a statistical significance of 0.05. We will be recruiting 40 participants per group (80 participants in total). Based on the 80 people recruited, we have a suitable power to find an effect, even after dropouts.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/05/2022
Actual
19/07/2022
Date of last participant enrolment
Anticipated
24/10/2022
Actual
28/10/2022
Date of last data collection
Anticipated
23/12/2022
Actual
23/12/2022
Sample size
Target
80
Accrual to date
Final
80
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 311146 0
Commercial sector/Industry
Name [1] 311146 0
Pharmactive Biotech Products, SL
Country [1] 311146 0
Spain
Primary sponsor type
Commercial sector/Industry
Name
Clinical Research Australia
Address
38 Arnisdale Rd Duncraig WA 6023
Country
Australia
Secondary sponsor category [1] 312493 0
None
Name [1] 312493 0
Address [1] 312493 0
Country [1] 312493 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310674 0
National Institute of Integrative Medicine (NIIM) Human Research Ethics Committee
Ethics committee address [1] 310674 0
11-23 Burwood Rd Hawthorn VIC 3122
Ethics committee country [1] 310674 0
Australia
Date submitted for ethics approval [1] 310674 0
15/03/2022
Approval date [1] 310674 0
14/04/2022
Ethics approval number [1] 310674 0
0101E_2022

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118474 0
Dr Adrian Lopresti
Address 118474 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 118474 0
Australia
Phone 118474 0
+61 08 9448 7376
Fax 118474 0
Email 118474 0
[email protected]
Contact person for public queries
Name 118475 0
Adrian Lopresti
Address 118475 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 118475 0
Australia
Phone 118475 0
+61 08 9448 7376
Fax 118475 0
Email 118475 0
[email protected]
Contact person for scientific queries
Name 118476 0
Adrian Lopresti
Address 118476 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 118476 0
Australia
Phone 118476 0
+61 08 9448 7376
Fax 118476 0
Email 118476 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
for IPD meta-analyses
How or where can data be obtained?
Access subject to approvals by Principal Investigator ([email protected])


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.