Evaluation of the Effects of Saffron Extract on Sleep Quality and Stress

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of the Effects of Saffron Extract on Sleep Quality and Stress

Conditions
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Insomnia, Stress

Intervention / Treatment
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* Dietary Supplement: Placebo
* Dietary Supplement: Saffron


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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); 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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized double-blind placebo-controlled interventional study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Each capsule contained 275mg of maltodextrin. Capsules were similar to the saffron investigation product (chlorophyll capsules). | Dietary Supplement: Placebo<br>* Subjects orally ingested, with water, one capsule per day (in the evening)<br>|
| Experimental: Saffron<br>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%). | Dietary Supplement: Saffron<br>* Subjects orally ingested, with water, one capsule per day (in the evening)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Leeds Sleep Evaluation Questionnaire score at 42 days | Questionnaire, score 0-100, higher score = better | Baseline (day-7 and day 0) and day 42 (end of the study) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Leeds Sleep Evaluation Questionnaire score at 21 days | Questionnaire, score 0-100, higher score = better | Baseline (day -7 and day 0) and day 21 | 
| Pittsburgh Sleep Quality Index | Questionnaire, score 0-21, higher score = worse | Baseline (day -7 and day 0) and day 42 (end of the study) | 
| Epworth Sleepiness Scale | Questionnaire, score 0-24, higher score = worse | 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 | 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 | Baseline (day -7 and day 0) and day 42 (end of the study) | 
| Time in bed | Actimetry | 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 | 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 | 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 | 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 | 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 | Baseline (from day -7 to day 0), third week (from day 14 to day 21), last week (from day 35 to 42) |