Clinical trial NCT04750681: Evaluation of the Effects of Saffron Extract on Sleep Quality and Stress
Official title: Evaluation of the Effects of Saffron Extract on Sleep Quality and Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Stress
Lead sponsor: Comercial Quimica Masso, S.A
Sponsor class: INDUSTRY
Collaborators: name: Université Catholique de Louvain
First posted: 2021-02-11
Enrollment: 66
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized double-blind placebo-controlled interventional study
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline Leeds Sleep Evaluation Questionnaire score at 42 days
timeFrame: Baseline (day-7 and day 0) and day 42 (end of the study)
Secondary outcomes:
measure: Change from baseline Leeds Sleep Evaluation Questionnaire score at 21 days
timeFrame: Baseline (day -7 and day 0) and day 21
measure: Pittsburgh Sleep Quality Index
timeFrame: Baseline (day -7 and day 0) and day 42 (end of the study)
measure: Epworth Sleepiness Scale
timeFrame: Baseline (day-7 and day 0), day 21 and day 42 (end of the study)
measure: Perceived Stress Scale
timeFrame: Baseline (day -7 and day 0) and day 42 (end of the study)
measure: Short Form (36) Health Survey
timeFrame: Baseline (day -7 and day 0) and day 42 (end of the study)
measure: Time in bed
timeFrame: Baseline (from day -7 to day 0), third week (from day 14 to day 21), last week (from day 35 to 42)
measure: Actual sleep time
timeFrame: Baseline (from day -7 to day 0), third week (from day 14 to day 21), last week (from day 35 to 42)
measure: Wake after sleep onset
timeFrame: Baseline (from day -7 to day 0), third week (from day 14 to day 21), last week (from day 35 to 42)
measure: Sleep onset latency
timeFrame: Baseline (from day -7 to day 0), third week (from day 14 to day 21), last week (from day 35 to 42)
measure: Fragmentation index
timeFrame: Baseline (from day -7 to day 0), third week (from day 14 to day 21), last week (from day 35 to 42)
measure: Sleep efficiency
timeFrame: Baseline (from day -7 to day 0), third week (from day 14 to day 21), last week (from day 35 to 42)
Other outcomes:
Locations:
city: Louvain-La-Neuve
country: Belgium
facility: UCLouvain - CICN
Study officials:
affiliation: Université Catholique de Louvain
name: Sylvie Copine, Dr
role: PRINCIPAL_INVESTIGATOR
References: