ANZCTR - Registration

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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 provided

28/03/2022

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]

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

Condition category

Condition code

Neurological

Other neurological disorders

Alternative and Complementary Medicine

Herbal remedies

Mental Health

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]

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]

Change in sleep quality as assessed by the Pittsburgh Sleep Diary sleep quality rating

Timepoint [1]

Days -1 to 28 (daily, with mean rating from days 21 to 28 being the primary timepoint)

Secondary outcome [1]

Change in sleeping patterns as assessed by the Pittsburgh Sleep Diary

Timepoint [1]

Days -1 to 28 (daily)

Secondary outcome [2]

Change in restorative sleep as assessed by the Restorative Sleep Questionnaire, Weekly Version (RSQ-W)

Timepoint [2]

Days 0, 7, 14, 21, and 28

Secondary outcome [3]

Change in quality of life associated with excess sleepiness as assessed by the Functional Outcomes of Sleep Questionnaire (FOSQ-10)

Timepoint [3]

Days 0 and 28

Secondary outcome [4]

Change in mood as assessed by the Profile of Mood States, abbreviated version

Timepoint [4]

Days 0, 7, 14, 21, and 28

Secondary outcome [5]

Change in insomnia symptoms as assessed by the Insomnia Symptoms Questionnaire (ISQ)

Timepoint [5]

Days 0 and 28

Secondary outcome [6]

Change in evening salivary cortisol concentrations

Timepoint [6]

Days -1 and 28

Secondary outcome [7]

Change in evening salivary melatonin concentrations

Timepoint [7]

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?

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]

Commercial sector/Industry

Name [1]

Pharmactive Biotech Products, SL

Address [1]

Avda.Severo Ochoa, 37 – Local 4J
28108. Alcobendas. Madrid. Spain

Country [1]

Spain

Primary sponsor type

Commercial sector/Industry

Name

Clinical Research Australia

Address

38 Arnisdale Rd Duncraig WA 6023

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

National Institute of Integrative Medicine (NIIM) Human Research Ethics Committee

Ethics committee address [1]

11-23 Burwood Rd
Hawthorn Melbourne VIC 3122

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

03/08/2020

Approval date [1]

28/09/2020

Ethics approval number [1]

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

Dr Adrian Lopresti

Address

Clinical Research Australia
38 Arnisdale Rd
Duncraig WA 6023

Country

Australia

Phone

+61894487376

Fax

adrian@clinicalresearch.com.au

Contact person for public queries

Name

Adrian Lopresti

Address

Clinical Research Australia
38 Arnisdale Rd
Duncraig WA 6023

Country

Australia

Phone

+61894487376

Fax

adrian@clinicalresearch.com.au

Contact person for scientific queries

Name

Adrian Lopresti

Address

Clinical Research Australia
38 Arnisdale Rd
Duncraig WA 6023

Country

Australia

Phone

+61894487376

Fax

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

Source	Title	Year of Publication	DOI
Embase	An 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.	2021	https://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.

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Documents added manually

Documents added automatically