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Trial registered on ANZCTR


Registration number
ACTRN12619000863134
Ethics application status
Approved
Date submitted
14/06/2019
Date registered
18/06/2019
Date last updated
15/10/2019
Date data sharing statement initially provided
18/06/2019
Date results information initially provided
15/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of saffron on sleep quality in healthy adults with self-reported unsatisfactory sleep.
Scientific title
Effects of saffron on sleep quality in healthy adults with self-reported unsatisfactory sleep: a randomised, double-blind, placebo-controlled study
Secondary ID [1] 298493 0
Nil known
Universal Trial Number (UTN)
U1111-1235-3385
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unsatisfactory sleep 313274 0
Condition category
Condition code
Neurological 311718 311718 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two tablets containing 14mg of a proprietary saffron extract (affron) (total daily dose of 28mg) will be consumed twice daily for 28 days (subsequent to 2 days of baseline monitoring) by adults aged between 18 and 70 years. Adherence to tablet intake will be monitored through tablet return and count.
Intervention code [1] 314745 0
Treatment: Other
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] 320414 0
Pittsburgh Sleep Diary (total sleep time, time taken to fall asleep, sleep efficiency, sleep quality rating)
Timepoint [1] 320414 0
Days -1, 0, 3, 7, 14, 27, and 28
Primary outcome [2] 320415 0
Insomnia Severity Index (ISI)
Timepoint [2] 320415 0
Days -1, 7, 14, 21, and 28
Secondary outcome [1] 371522 0
Restorative Sleep Questionnaire (RSQ)
Timepoint [1] 371522 0
Days -1, 0, 3, 7, 14, 27, and 28
Secondary outcome [2] 371523 0
Depression, Anxiety, and Stress Scale (DASS-21)
Timepoint [2] 371523 0
Days 0 and 28

Eligibility
Key inclusion criteria
1. Healthy adults (male and female) between 18 and 70
2. Self-reported symptoms of unsatisfactory sleep lasting greater than 4 weeks (as measured by a score between 8 and 21 on the Insomnia Sleep Index)
3. Medication-free for at least 4 weeks apart from the contraceptive pill and no more than once a week use of pain-relieving medications.
4. Non-smoker
5. BMI between 20 and 30
6. Typical bedtime between 9 p.m. and 12 a.m.
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
Gender
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 sleep disorder other than moderate insomnia (e.g, sleep apnoea, restless leg syndrome, periodic limb movement disorder)
3. Chronic sleep disturbance greater than 1 year
4. Suffer from mental health disorder (other than mild depressive or anxiety symptoms as measured by the Depression, Anxiety and Stress Scale-21)
5. Coffee intake greater than 3 cups a day (or equivalent caffeine intake from other caffeinated drinks e.g., tea, energy drinks)
6. Alcohol consumption > 14 standard drinks per week
7. Experiencing external factors that may affect sleep patterns (e.g., infant/children regularly awakening, excess noise, snoring partner, pain condition)
8. Currently receiving non-pharmacological treatment of sleep disorders (e.g., cognitive behavioural therapy, relaxation therapy)
9. Current or 12-month history of illicit drug abuse
10. Pregnant women, women who are breastfeeding or women who intended to fall pregnant.
11. Suffering from medical conditions including but not limited to: diabetes, hyper/hypotension, cardiovascular disease, gastrointestinal disease requiring regular use of medications, gallbladder disease/gallstones/biliary disease, endocrine disease, psychiatric disorder, and neurological disease (Parkinson’s, Alzheimer’s disease, intracranial haemorrhage, head or brain injury), acute or chronic pain affecting sleep
12. Current use of supplements that may affect sleep
13. 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)
Participants will be randomly allocated into placebo and treatment groups. These groups are named group 1 and group 2 and the primary investigator and participants will be unaware of which treatment these groups represent. Each participant will be allocated a participant number (1 to 50) based on the order of inclusion in the study. A computer-generated software will randomly assign the numbers 1 to 50 into either group 1 or 2.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple 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

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Based on previous studies using saffron, we are predicting a large effect size of 0.8. Based on this, a total sample size of 42 is required. This gives an 80% chance of finding an effect at a statistical significance of 0.05. In this study, we will be recruiting 50 participants, which should give us the suitable power to find an effect, even after dropouts.

Pre and post analyses will be conducted to determine changes in the following:
1. Pittsburgh Sleep diary (total sleep time, time taken to fall asleep, sleep efficiency, sleep quality rating)
2. Insomnia Severity Index (ISI)
3. Restorative Sleep Questionnaire (RSQ)
4. Depression, Anxiety, and Stress Scale (DASS-21).

Comparisons will be made between the two conditions to determine if changes in symptoms are significantly different.

These analyses will be conducted via a repeated measures analysis of variance via SPSS

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 303038 0
Commercial sector/Industry
Name [1] 303038 0
Pharmactive
Address [1] 303038 0
Avda.Severo Ochoa, 37 – Local 4J
28108. Alcobendas. Madrid. Spain
Country [1] 303038 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] 303020 0
None
Name [1] 303020 0
Address [1] 303020 0
Country [1] 303020 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303591 0
National Institute of Integrative Medicine (NIIM)
Ethics committee address [1] 303591 0
11-23 Burwood Rd
Hawthorn Melbourne VIC 3122
Ethics committee country [1] 303591 0
Australia
Date submitted for ethics approval [1] 303591 0
08/04/2019
Approval date [1] 303591 0
30/04/2019
Ethics approval number [1] 303591 0
0054E_2019

Summary
Brief summary
In this randomised, double-blind, placebo-controlled study, 50 adults who are currently experiencing unsatisfactory sleep will be randomly assigned to receive tablets containing either a saffron extract (28mg a day) or placebo for 28 days. We will assess change in sleep habits, sleep quality, severity of insomnia, restorative effects of sleep, and depression, anxiety, and stress scores via several validated self-report measures (to be completed at various time points throughout the study).
Trial website
www.clinicalresearch.com.au/cra-studies/saffron-sleep-study/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94182 0
Dr Adrian Lopresti
Address 94182 0
Clinical Research Australia
38 Arnisdale Rd
Duncraig WA 6023
Country 94182 0
Australia
Phone 94182 0
+61894487376
Fax 94182 0
+61894478217
Email 94182 0
adrian@clinicalresearch.com.au
Contact person for public queries
Name 94183 0
Dr Adrian Lopresti
Address 94183 0
Clinical Research Australia
38 Arnisdale Rd
Duncraig WA 6023
Country 94183 0
Australia
Phone 94183 0
+61894487376
Fax 94183 0
+61894478217
Email 94183 0
adrian@clinicalresearch.com.au
Contact person for scientific queries
Name 94184 0
Dr Adrian Lopresti
Address 94184 0
Clinical Research Australia (CRA)
38 Arnisdale Rd
Duncraig WA 6023
Country 94184 0
Australia
Phone 94184 0
+61894487376
Fax 94184 0
+61894478217
Email 94184 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
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary