Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000973910
Ethics application status
Approved
Date submitted
1/09/2020
Date registered
28/09/2020
Date last updated
28/03/2022
Date data sharing statement initially provided
28/09/2020
Date results information initially provided
29/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Saffron and its effects on sleep quality in adults with unsatisfactory sleep
Scientific title
Effects of saffron on sleep quality in adults with unsatisfactory sleep: a randomised, double-blind, placebo-controlled study
Secondary ID [1] 302203 0
Nil known
Universal Trial Number (UTN)
U1111-1257-7240
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unsatisfactory sleep 318892 0
Condition category
Condition code
Neurological 316876 316876 0 0
Other neurological disorders
Alternative and Complementary Medicine 316877 316877 0 0
Herbal remedies
Mental Health 317188 317188 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Condition 1: Placebo tablets (1 tablet taken in the evening, 1 hour before bedtime, for 4 weeks)

Condition 2: Saffron extract (affron) (1 tablet taken in the evening, 1 hour before bedtime, delivering 28mg, for 4 weeks)

Condition 3: Saffron extract (affron) (1 tablet taken in the evening, 1 hour before bedtime, delivering 14mg, for 4 weeks)

Adherence to tablet intake will be monitored through tablet return and count.
Intervention code [1] 318496 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] 324981 0
Change in sleep quality as assessed by the Pittsburgh Sleep Diary sleep quality rating
Timepoint [1] 324981 0
Days -1 to 28 (daily, with mean rating from days 21 to 28 being the primary timepoint)
Secondary outcome [1] 386436 0
Change in sleeping patterns as assessed by the Pittsburgh Sleep Diary
Timepoint [1] 386436 0
Days -1 to 28 (daily)
Secondary outcome [2] 386437 0
Change in restorative sleep as assessed by the Restorative Sleep Questionnaire, Weekly Version (RSQ-W)
Timepoint [2] 386437 0
Days 0, 7, 14, 21, and 28
Secondary outcome [3] 386438 0
Change in quality of life associated with excess sleepiness as assessed by the Functional Outcomes of Sleep Questionnaire (FOSQ-10)
Timepoint [3] 386438 0
Days 0 and 28
Secondary outcome [4] 386439 0
Change in mood as assessed by the Profile of Mood States, abbreviated version
Timepoint [4] 386439 0
Days 0, 7, 14, 21, and 28
Secondary outcome [5] 386440 0
Change in insomnia symptoms as assessed by the Insomnia Symptoms Questionnaire (ISQ)
Timepoint [5] 386440 0
Days 0 and 28
Secondary outcome [6] 386441 0
Change in evening salivary cortisol concentrations
Timepoint [6] 386441 0
Days -1 and 28
Secondary outcome [7] 386442 0
Change in evening salivary melatonin concentrations
Timepoint [7] 386442 0
Days -1 and 28

Eligibility
Key inclusion criteria
1. Healthy adults (male and female) between 18 and 70
2. Self-reported symptoms of poor sleep lasting longer than 4 weeks
3. Non-smoker
4. BMI between 20 and 35
5. Typical bedtime between 9 p.m. and 12 a.m.
6. 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. Employed in night shift work or rotational shift work
2. Suffer from a sleep disorder other than moderate insomnia (e.g, sleep apnoea, restless leg syndrome, periodic limb movement disorder)
3. Suffer from mental health disorder other than mild depressive or anxiety symptoms as measured by the Patient Health Questionnaire (PHQ-4)
4. Coffee intake greater than 3 cups a day (or equivalent caffeine intake from other caffeinated drinks e.g., tea, energy drinks)
5. Alcohol consumption > 14 standard drinks per week
6. Experiencing external factors that may affect sleep patterns (e.g., infant/children regularly wakening, excess noise, a snoring partner, pain condition)
7. Currently receiving non-pharmacological treatment of sleep disorders (e.g., cognitive behavioural therapy, relaxation therapy)
8. Current or 12-month history of illicit drug abuse
9. Pregnant women, women who are breastfeeding, or women who intended to fall pregnant.
10. 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
11. 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), and cancer/malignancy
12. Current use of pharmaceutical medications that may affect sleep quality
13. Current use of supplements that may affect sleep
14. Currently taking saffron supplements

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 12 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
Not applicable
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on a previous study on saffron for the treatment of sleep problems, we are predicting an effect size of 0.7 compared to placebo. Based on this, a sample size of 35 is required per group. This gives an 80% chance of finding an effect at a statistical significance of 0.05. In this study, we will be recruiting 40 participants per group (120 participants in total), which should give us a suitable power to find an effect, even after dropouts.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/09/2020
Actual
30/09/2020
Date of last participant enrolment
Anticipated
29/01/2021
Actual
6/11/2020
Date of last data collection
Anticipated
26/02/2021
Actual
17/12/2020
Sample size
Target
120
Accrual to date
Final
120
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA

Funding & Sponsors
Funding source category [1] 306624 0
Commercial sector/Industry
Name [1] 306624 0
Pharmactive Biotech Products, SL
Country [1] 306624 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] 307154 0
None
Name [1] 307154 0
Address [1] 307154 0
Country [1] 307154 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306809 0
National Institute of Integrative Medicine (NIIM) Human Research Ethics Committee
Ethics committee address [1] 306809 0
11-23 Burwood Rd
Hawthorn Melbourne VIC 3122
Ethics committee country [1] 306809 0
Australia
Date submitted for ethics approval [1] 306809 0
03/08/2020
Approval date [1] 306809 0
28/09/2020
Ethics approval number [1] 306809 0
0073E_2020

Summary
Brief summary
In this randomised, double-blind, placebo-controlled study, 120 adults who are currently experiencing unsatisfactory sleep will be randomly assigned to receive tablets containing either a high-dose saffron extract (28mg a day), low-dose saffron extract (14mg a day), or placebo for 28 days.. We will assess change in sleep quality, quality of life, and mood via several validated self-report measures (to be completed at various time points throughout the study). We will also examine changes in evening salivary concentrations of cortisol and melatonin.
Trial website
https://clinicalresearch.com.au/cra-studies/saffron-sleep-study2
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 105086 0
Dr Adrian Lopresti
Address 105086 0
Clinical Research Australia
38 Arnisdale Rd
Duncraig WA 6023
Country 105086 0
Australia
Phone 105086 0
+61894487376
Fax 105086 0
Email 105086 0
[email protected]
Contact person for public queries
Name 105087 0
Dr Adrian Lopresti
Address 105087 0
Clinical Research Australia
38 Arnisdale Rd
Duncraig WA 6023
Country 105087 0
Australia
Phone 105087 0
+61894487376
Fax 105087 0
Email 105087 0
[email protected]
Contact person for scientific queries
Name 105088 0
Dr Adrian Lopresti
Address 105088 0
Clinical Research Australia
38 Arnisdale Rd
Duncraig WA 6023
Country 105088 0
Australia
Phone 105088 0
+61894487376
Fax 105088 0
Email 105088 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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Lopresti, et al. An investigation into an evening ... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAn investigation into an evening intake of a saffron extract (affron) on sleep quality, cortisol, and melatonin concentrations in adults with poor sleep: a randomised, double-blind, placebo-controlled, multi-dose study.2021https://dx.doi.org/10.1016/j.sleep.2021.08.001
N.B. These documents automatically identified may not have been verified by the study sponsor.