Stress Clinical Trial
Official title:
Evaluation of the Effects of Saffron Extract on Sleep Quality and Stress
Verified date | January 2021 |
Source | Comercial Quimica Masso, S.A |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 66 |
Est. completion date | November 3, 2020 |
Est. primary completion date | November 3, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 25 Years to 70 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Belgium | UCLouvain - CICN | Louvain-La-Neuve |
Lead Sponsor | Collaborator |
---|---|
Comercial Quimica Masso, S.A | Université Catholique de Louvain |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | Pittsburgh Sleep Quality Index | Questionnaire, score 0-21, higher score = worse | Baseline (day -7 and day 0) and day 42 (end of the study) | |
Secondary | 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) | |
Secondary | Perceived Stress Scale | Questionnaire, score 0-40, higher score = worse | Baseline (day -7 and day 0) and day 42 (end of the study) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) |
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