InsomniaNCT04750681
Evaluation of the Effects of Saffron Extract on Sleep Quality and Stress
A study testing Saffron in people with Insomnia and Stress, run by Comercial Quimica Masso, S.A at 1 site in Belgium.
Trial summary
Therefore, the aim of this study was to confirm by a randomized double-blind controlled study the beneficial effects of saffron extract (Saffr'activ®) on sleep quality in subjects presenting mild to moderate sleep disorder associated with anxiety. Read more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- What is being tested?
- Saffron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteBelgium
- Study dates
- 12 Aug 2019to 3 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- In good general health as evidenced by medical history and physical examination;
- Presenting mild to moderate chronic primary sleep disorder (evaluated by Insomnia Severity Index - ISI, score between 7 and 21);
- Presenting mild to moderate anxiety (evaluated by Perceived Stress Scale - PSS, score between 6 and 29);
- For women: use of effective contraception;
- Fluent French speaking;
- Provision of signed and dated informed consent form;
- Stated willingness to comply with all study procedures and availability for the duration of the study.
Who cannot join
- Sleep disorders secondary to another health problem;
- Lifestyle habits which would modify the wake-sleep rhythm (e.g. night work) or which would be modified during the study period;
- Pharmacological resistance to common hypnotic drugs or consumption of hypnotic drugs (< 3 months before the inclusion);
- Subjects presenting gastro-intestinal, hepatic, respiratory, psychiatric, kidney or cardiovascular disorders (< 3 months before the inclusion);
- Abnormal blood sampling;
- Subjects presenting depressive disorder (BDI score > 30);
Show all 14Show fewer
- Recent (< 3 months before the inclusion) change in lifestyle (food, body weight > 5kg, sport);
- Within 3 months before the inclusion, chronic (> 7 days in a row) intake or dosage change of drug(s) or food supplement(s);
- Addict subjects or with historical addiction;
- Subjects who drink more than 3 glasses of alcohol per day (> 30g of alcohol per day);
- Exaggerated consumption of theine (≥ 500ml per day) and caffeine-rich (≥ 400ml per day) beverages and energy drink (≥ 250ml per day);
- Pregnant or lactating woman;
- Known allergy to saffron and/or olives;
- Subjects having participated to another clinical trial one month before the selection visit.
Trial locations and contacts
1 site in 1 country.
About this study
Therefore, the aim of this study was to confirm by a randomized double-blind controlled study the beneficial effects of saffron extract (Saffr'activ®) on sleep quality in subjects presenting mild to moderate sleep disorder associated with anxiety.
Read the detailed description
This study has been designed as a randomized double-blind placebo-controlled interventional study.
Sixty-six subjects were randomly allocated to the control (placebo) or test (Saffr'activ®) group.
A screening visit was scheduled within 4 weeks before Day -7 (study inclusion). At Day -7 and Day 0, questionnaires were completed to evaluate sleep quality, stress level and quality of life. Between Day -7 and Day 0 baseline data for actimeter and sleep diary were registered. Then, subjects were supplemented during 6 weeks with the placebo or saffron (Saffr'activ®) product, depending on their group. Following the baseline period, two other periods of one week were scheduled to collect actigraphy data: between 2 and 3 (from Day 14 to Day 21) weeks and between 5 and 6 (from Day 35 to Day 42) weeks after the beginning of the intervention. At the middle (Day 21) and at the end of the study (Day 42), questionnaires were completed to evaluate sleep quality, stress level and/or quality of life.
- Being tested
- Placebo, Saffron
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Subjects orally ingested, with water, one capsule per day (in the evening)
SaffronDietary supplement
Subjects orally ingested, with water, one capsule per day (in the evening)
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Each capsule contained 275mg of maltodextrin. Capsules were similar to the saffron investigation product (chlorophyll capsules). Receives: Dietary Supplement: Placebo |
| Saffron | Experimental | Each capsule contained 259,5mg of maltodextrin and 15,5mg of saffron extract (Saffr'activ® SAF 3C PIM) that corresponds to 1,6mg of dry saffron extract, 0,9mg of crocins (5.82%) and 0,7mg of safranal (4.6%). Receives: Dietary Supplement: Saffron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Leeds Sleep Evaluation Questionnaire score at 42 days
Questionnaire, score 0-100, higher score = better
Measured: Baseline (day-7 and day 0) and day 42 (end of the study)
Secondary outcomes (11)
Change from baseline Leeds Sleep Evaluation Questionnaire score at 21 days
Questionnaire, score 0-100, higher score = better
Measured: Baseline (day -7 and day 0) and day 21
Pittsburgh Sleep Quality Index
Questionnaire, score 0-21, higher score = worse
Measured: Baseline (day -7 and day 0) and day 42 (end of the study)
Epworth Sleepiness Scale
Questionnaire, score 0-24, higher score = worse
Measured: Baseline (day-7 and day 0), day 21 and day 42 (end of the study)
Perceived Stress Scale
Questionnaire, score 0-40, higher score = worse
Measured: Baseline (day -7 and day 0) and day 42 (end of the study)
Short Form (36) Health Survey
Questionnaire, score 0-100, higher score = better
Measured: Baseline (day -7 and day 0) and day 42 (end of the study)
Time in bed
Actimetry
Measured: Baseline (from day -7 to day 0), third week (from day 14 to day 21), last week (from day 35 to 42)
Actual sleep time
Actimetry
Measured: Baseline (from day -7 to day 0), third week (from day 14 to day 21), last week (from day 35 to 42)
Wake after sleep onset
Actimetry
Measured: Baseline (from day -7 to day 0), third week (from day 14 to day 21), last week (from day 35 to 42)
Sleep onset latency
Actimetry
Measured: Baseline (from day -7 to day 0), third week (from day 14 to day 21), last week (from day 35 to 42)
Fragmentation index
Actimetry
Measured: Baseline (from day -7 to day 0), third week (from day 14 to day 21), last week (from day 35 to 42)
Sleep efficiency
Actimetry
Measured: Baseline (from day -7 to day 0), third week (from day 14 to day 21), last week (from day 35 to 42)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start12 Aug 2019
- Primary completion3 Nov 2020
- Study completion3 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized double-blind placebo-controlled interventional study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Comercial Quimica Masso, S.A
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Université Catholique de Louvain
- Responsible party
- Sponsor
- Investigators
- Sylvie Copine, Dr, Principal investigator, Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04750681
- Sponsor's protocol ID
- Saffractiv2019
- Status last verified
- Jan 2021
- First submitted
- 28 Jan 2021
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Saffron Extract on Sleep Quality and Stress
- ClinicalTrials.gov ID
- NCT04750681
- Acronym / sponsor ID
- Saffractiv2019
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Comercial Quimica Masso, S.AIndustry (pharma, biotech, devices)
- Collaborators
- Université Catholique de Louvain
- Study start
- 12 Aug 2019 (actual)
- Primary completion
- 3 Nov 2020 (actual)
- Study completion
- 3 Nov 2020 (actual)
- First posted
- 11 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Therefore, the aim of this study was to confirm by a randomized double-blind controlled study the beneficial effects of saffron extract (Saffr'activ®) on sleep quality in subjects presenting mild to moderate sleep disorder associated with anxiety.
Detailed description
This study has been designed as a randomized double-blind placebo-controlled interventional study.
Sixty-six subjects were randomly allocated to the control (placebo) or test (Saffr'activ®) group.
A screening visit was scheduled within 4 weeks before Day -7 (study inclusion). At Day -7 and Day 0, questionnaires were completed to evaluate sleep quality, stress level and quality of life. Between Day -7 and Day 0 baseline data for actimeter and sleep diary were registered. Then, subjects were supplemented during 6 weeks with the placebo or saffron (Saffr'activ®) product, depending on their group. Following the baseline period, two other periods of one week were scheduled to collect actigraphy data: between 2 and 3 (from Day 14 to Day 21) weeks and between 5 and 6 (from Day 35 to Day 42) weeks after the beginning of the intervention. At the middle (Day 21) and at the end of the study (Day 42), questionnaires were completed to evaluate sleep quality, stress level and/or quality of life.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized double-blind placebo-controlled interventional study
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Dietary Supplement: PlaceboEach capsule contained 275mg of maltodextrin. Capsules were similar to the saffron investigation product (chlorophyll capsules). |
| Saffron | Experimental | Dietary Supplement: SaffronEach capsule contained 259,5mg of maltodextrin and 15,5mg of saffron extract (Saffr'activ® SAF 3C PIM) that corresponds to 1,6mg of dry saffron extract, 0,9mg of crocins (5.82%) and 0,7mg of safranal (4.6%). |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- In good general health as evidenced by medical history and physical examination;
- Presenting mild to moderate chronic primary sleep disorder (evaluated by Insomnia Severity Index - ISI, score between 7 and 21);
- Presenting mild to moderate anxiety (evaluated by Perceived Stress Scale - PSS, score between 6 and 29);
- For women: use of effective contraception;
- Fluent French speaking;
Key exclusion criteria (14 listed)
- Sleep disorders secondary to another health problem;
- Lifestyle habits which would modify the wake-sleep rhythm (e.g. night work) or which would be modified during the study period;
- Pharmacological resistance to common hypnotic drugs or consumption of hypnotic drugs (< 3 months before the inclusion);
- Subjects presenting gastro-intestinal, hepatic, respiratory, psychiatric, kidney or cardiovascular disorders (< 3 months before the inclusion);
- Abnormal blood sampling;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboSubjects orally ingested, with water, one capsule per day (in the evening) | Dietary supplement | Control |
| SaffronSubjects orally ingested, with water, one capsule per day (in the evening) | Dietary supplement | Saffron |
Primary outcome
Change from baseline Leeds Sleep Evaluation Questionnaire score at 42 days
Time frame: Baseline (day-7 and day 0) and day 42 (end of the study)
Questionnaire, score 0-100, higher score = better
11 secondary outcomes
Change from baseline Leeds Sleep Evaluation Questionnaire score at 21 days
Time frame: Baseline (day -7 and day 0) and day 21
Pittsburgh Sleep Quality Index
Time frame: Baseline (day -7 and day 0) and day 42 (end of the study)
Epworth Sleepiness Scale
Time frame: Baseline (day-7 and day 0), day 21 and day 42 (end of the study)
Perceived Stress Scale
Time frame: Baseline (day -7 and day 0) and day 42 (end of the study)
Short Form (36) Health Survey
Time frame: Baseline (day -7 and day 0) and day 42 (end of the study)
Time in bed
Time frame: Baseline (from day -7 to day 0), third week (from day 14 to day 21), last week (from day 35 to 42)
Actual sleep time
Time frame: Baseline (from day -7 to day 0), third week (from day 14 to day 21), last week (from day 35 to 42)
Wake after sleep onset
Time frame: Baseline (from day -7 to day 0), third week (from day 14 to day 21), last week (from day 35 to 42)
Sleep onset latency
Time frame: Baseline (from day -7 to day 0), third week (from day 14 to day 21), last week (from day 35 to 42)
Fragmentation index
Time frame: Baseline (from day -7 to day 0), third week (from day 14 to day 21), last week (from day 35 to 42)
Sleep efficiency
Time frame: Baseline (from day -7 to day 0), third week (from day 14 to day 21), last week (from day 35 to 42)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvie Copine, Dr principal investigator
Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saffron in people with Insomnia and Stress, run by Comercial Quimica Masso, S.A at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Leeds Sleep Evaluation Questionnaire score at 42 days (time frame: Baseline (day-7 and day 0) and day 42 (end of the study)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2021.