Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001358639
Ethics application status
Approved
Date submitted
12/12/2023
Date registered
21/12/2023
Date last updated
1/06/2024
Date data sharing statement initially provided
21/12/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
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
Scientific title
An examination into the effects of a saffron extract (affron) on mood and general wellbeing in adults experiencing low mood
Secondary ID [1] 311164 0
None
Universal Trial Number (UTN)
U1111-1301-6293
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low mood 332329 0
Anxiety 332330 0
Sleep 332331 0
Condition category
Condition code
Mental Health 329041 329041 0 0
Depression
Mental Health 329042 329042 0 0
Anxiety
Mental Health 329043 329043 0 0
Other mental health disorders
Alternative and Complementary Medicine 329044 329044 0 0
Herbal remedies

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 12 weeks). Adherence to tablet intake will be measured by a daily record of tablet intake using a phone application and a tablet count by the participants at week 12.
Intervention code [1] 327607 0
Treatment: Other
Comparator / control treatment
A matching placebo (containing cellulose) in terms of taste and appearance and containing all ingredients except the active ingredient (saffron extract)
Control group
Placebo

Outcomes
Primary outcome [1] 336847 0
Low mood
Timepoint [1] 336847 0
Day 0 (pre-commencement of intervention), week 4, 8, and 12 (primary endpoint) post-intervention commencement
Secondary outcome [1] 429830 0
Anxiety
Timepoint [1] 429830 0
Day 0 (pre-commencement of intervention), week 4, 8, and 12 post-intervention commencement
Secondary outcome [2] 429831 0
Stress
Timepoint [2] 429831 0
Day 0 (pre-commencement of intervention), week 4, 8, and 12 post-intervention commencement
Secondary outcome [3] 429832 0
Low mood
Timepoint [3] 429832 0
Day 0 (pre-commencement of intervention) and every second day for 12 weeks (post-intervention commencement)
Secondary outcome [4] 429833 0
Anxiety
Timepoint [4] 429833 0
Day 0 (pre-commencement of intervention) and every second day for 12 weeks (post-intervention commencement)
Secondary outcome [5] 429834 0
Stress
Timepoint [5] 429834 0
Day 0 (pre-commencement of intervention) and every second day for 12 weeks (post-intervention commencement)
Secondary outcome [6] 429835 0
Sleep
Timepoint [6] 429835 0
Day 0 (pre-commencement of intervention), week 4, 8, and 12 post-intervention commencement
Secondary outcome [7] 429837 0
Sleep
Timepoint [7] 429837 0
Day 0 (pre-commencement of intervention), week 4, 8, and 12 post-intervention commencement
Secondary outcome [8] 429838 0
General Wellbeing
Timepoint [8] 429838 0
Day 0 (pre-commencement of intervention), week 4, 8, and 12 post-intervention commencement

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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 computer software
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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
29/01/2024
Actual
1/05/2024
Date of last participant enrolment
Anticipated
30/08/2024
Actual
Date of last data collection
Anticipated
30/11/2024
Actual
Sample size
Target
200
Accrual to date
20
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC

Funding & Sponsors
Funding source category [1] 315419 0
Commercial sector/Industry
Name [1] 315419 0
Pharmactive Biotech Products, SL
Country [1] 315419 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] 317482 0
None
Name [1] 317482 0
Address [1] 317482 0
Country [1] 317482 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314335 0
National Institute of Integrative Medicine (NIIM) Human Research Ethics Committee
Ethics committee address [1] 314335 0
11-23 Burwood Rd Hawthorn VIC 3122
Ethics committee country [1] 314335 0
Australia
Date submitted for ethics approval [1] 314335 0
07/11/2023
Approval date [1] 314335 0
05/12/2023
Ethics approval number [1] 314335 0
0134E_2023

Summary
Brief summary
In this randomised, double-blind, placebo-controlled study, 200 adults aged 18 to 70 years with self-reported low mood will be randomly assigned to receive 14mg twice daily of a saffron extract (affron) or a placebo for 12 weeks. Changes in mood, sleep, and quality of life through the administration of validated self-report questionnaires will be assessed over time.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131222 0
Dr Adrian Lopresti
Address 131222 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 131222 0
Australia
Phone 131222 0
+61 08 9448 7376
Fax 131222 0
Email 131222 0
adrian@clinicalresearch.com.au
Contact person for public queries
Name 131223 0
Dr Adrian Lopresti
Address 131223 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 131223 0
Australia
Phone 131223 0
+61 08 9448 7376
Fax 131223 0
Email 131223 0
adrian@clinicalresearch.com.au
Contact person for scientific queries
Name 131224 0
Dr Adrian Lopresti
Address 131224 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 131224 0
Australia
Phone 131224 0
+61 08 9448 7376
Fax 131224 0
Email 131224 0
adrian@clinicalresearch.com.au

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 (adrian@clinicalresearch.com.au)


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.