Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000501842
Ethics application status
Approved
Date submitted
26/03/2021
Date registered
29/04/2021
Date last updated
12/08/2022
Date data sharing statement initially provided
29/04/2021
Date results provided
12/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of a saffron extract (affron) on mood, sleep, physical, and mental recovery in recreationally-active adults: a randomised, double-blind, placebo-controlled study
Scientific title
Effects of a saffron extract (affron) on mood, sleep, physical, and mental recovery in recreationally-active adults
Secondary ID [1] 303811 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Poor recovery from exercise 321316 0
Condition category
Condition code
Alternative and Complementary Medicine 319104 319104 0 0
Herbal remedies
Musculoskeletal 319419 319419 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Condition 1: Placebo tablets (1 tablet taken orally, twice daily for 6 weeks)

Condition 2: Saffron extract (affron) (1 tablet taken orally, twice daily, delivering 28mg a day, for 6 weeks)

Adherence to tablet intake will be monitored through a mobile phone app and tablet return and count.
Intervention code [1] 320114 0
Treatment: Drugs
Comparator / control treatment
Placebo (containing microcellulose) is matched to the saffron tablets in terms of taste and appearance but does not contain any of the active ingredients.
Control group
Placebo

Outcomes
Primary outcome [1] 326990 0
Change in Physical Activity Enjoyment Scale (PACES)
Timepoint [1] 326990 0
Day 0, and weeks 2, 4, and 6 (primary endpoint) post-intervention commencement
Secondary outcome [1] 393362 0
Change in Profile of Mood States, abbreviated version (POMS-A)
Timepoint [1] 393362 0
Day 0, and weeks 2, 4, and 6 post-intervention commencement
Secondary outcome [2] 393363 0
Change in Patient-Reported Outcomes Measurement Information System - 29 (PROMIS-29)
Timepoint [2] 393363 0
Day 0, and weeks 2, 4, and 6 post-intervention commencement
Secondary outcome [3] 393365 0
Change in heart rate variability as measured by the WHOOP strap
Timepoint [3] 393365 0
Weekly average of weeks 1, 2, 3, 4, 5, and 6 post-intervention commencement
Secondary outcome [4] 393366 0
Change in total sleep time as measured by the WHOOP strap
Timepoint [4] 393366 0
Weekly average of weeks 1, 2, 3, 4, 5, and 6 post-intervention commencement
Secondary outcome [5] 393369 0
Change in sleep efficiency as measured by the WHOOP strap
Timepoint [5] 393369 0
Weekly average of weeks 1, 2, 3, 4, 5, and 6 post-intervention commencement
Secondary outcome [6] 393370 0
Change in time sleep latency as measured by the WHOOP strap
Timepoint [6] 393370 0
Weekly average of weeks 1, 2, 3, 4, 5, and 6 post-intervention commencement
Secondary outcome [7] 393371 0
Change in resting heart rate as measured by the WHOOP strap
Timepoint [7] 393371 0
Weekly average of weeks 1, 2, 3, 4, 5, and 6 post-intervention commencement
Secondary outcome [8] 393372 0
Change in blood concentrations of brain-derived neurotropic factor
Timepoint [8] 393372 0
Day 0 and week 6 post-intervention commencement
Secondary outcome [9] 393373 0
Change in blood concentrations of neuropeptide Y
Timepoint [9] 393373 0
Day 0 and week 6 post-intervention commencement
Secondary outcome [10] 393374 0
Change in blood concentrations of oxytocin
Timepoint [10] 393374 0
Day 0 and week 6 post-intervention commencement

Eligibility
Key inclusion criteria
1. Healthy adults (male and female) 18 to 65 years
2. Engaging in non-professional, moderate-to-intensive aerobic exercise greater than 3 times per week comprising the following activities: running, cycling, swimming, tennis, aerobics, boxing
3. Exercise sessions are greater than 45 minutes and commenced more than 6 months ago
4. Engage in moderate-to-intensive aerobic exercise no more than 14 hrs a week
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?
Yes
Key exclusion criteria
1. Suffering from recently diagnosed or unmanaged medical conditions including but not limited to: diabetes, hyper/hypotension, cardiovascular disease, gastrointestinal disease requiring regular use of medications, gallbladder disease/gallstones/biliary disease, autoimmune disease, endocrine disease, acute or chronic pain condition
2. Diagnosis of medical or psychiatric conditions including but not limited to: psychiatric disorder (other than mild-to-moderate depression or anxiety), neurological disease (Parkinson’s, Alzheimer’s disease, intracranial haemorrhage, head or brain injury), or cancer/malignancy
3. Regular medication intake including but not limited to anticoagulants and anti-hypertensive drugs, anticholinergics, acetylcholinesterase inhibitors, or steroid medications.
4. Change in medication in the last 3 months or an expectation to change during the study duration
5. Currently experiencing significant injuries that may affect the ability to engage in exercise
6. Taking vitamins, herbal, or other nutritional supplements that are reasonably expected to influence study measures.
7. Current or 12-month history of illicit drug abuse
8. Alcohol intake greater than 14 standard drinks per week
9. Consume more than 3 cups a day of coffee (or other caffeinated beverage).
10. Any significant surgeries over the last year
11. Planned major lifestyle change in the next 8 weeks

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 not concealed
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 10 randomly permuted blocks, containing 6 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
There has been no previous trial examining the effects of saffron on physical and mental recovery in recreationally-active adults. In this exploratory trial, a convenience sample size of 60 adults will be recruited. If an effect size of 0.7 compared to the placebo is obtained, this will give an 80% chance of finding an effect at a statistical significance of 0.05 (after dropouts).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/04/2021
Actual
18/06/2021
Date of last participant enrolment
Anticipated
Actual
26/08/2021
Date of last data collection
Anticipated
Actual
15/10/2021
Sample size
Target
60
Accrual to date
Final
62
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 308209 0
Commercial sector/Industry
Name [1] 308209 0
Pharmactive Biotech Products, SL
Country [1] 308209 0
Spain
Primary sponsor type
Commercial sector/Industry
Name
Clinical Research Australia
Address
38 Arnisdale Road Duncraig WA 6023
Country
Australia
Secondary sponsor category [1] 308992 0
None
Name [1] 308992 0
Address [1] 308992 0
Country [1] 308992 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308190 0
National Institute of Integrative Medicine (NIIM) Human Research Ethics Committee
Ethics committee address [1] 308190 0
Ethics committee country [1] 308190 0
Australia
Date submitted for ethics approval [1] 308190 0
02/02/2021
Approval date [1] 308190 0
29/03/2021
Ethics approval number [1] 308190 0
0084E_2021

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109866 0
Dr Adrian Lopresti
Address 109866 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 109866 0
Australia
Phone 109866 0
+61 894487376
Fax 109866 0
Email 109866 0
[email protected]
Contact person for public queries
Name 109867 0
Adrian Lopresti
Address 109867 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 109867 0
Australia
Phone 109867 0
+61 894487376
Fax 109867 0
Email 109867 0
[email protected]
Contact person for scientific queries
Name 109868 0
Adrian Lopresti
Address 109868 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 109868 0
Australia
Phone 109868 0
+61 894487376
Fax 109868 0
Email 109868 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.