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

Not Applicable

Completed

• Conditions: Insomnia; Stress
• Interventions: Dietary Supplement: Saffron; Dietary Supplement: Placebo

• Registration Number: NCT04750681
• Lead Sponsor: Comercial Quimica Masso, S.A

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.

Study Timeline

• Study Start: 2019-08-12
• Primary Completion: 2020-11-03
• Study Completion: 2020-11-03
• Status Verified: 2021-01
• Study First Submitted: 2021-01-28
• Study First Submitted QC: 2021-02-10
• Last Update Submitted: 2021-02-10
• Study First Posted: 2021-02-11
• Last Update Posted: 2021-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saffron	Saffron	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%).
Control	Placebo	Each capsule contained 275mg of maltodextrin. Capsules were similar to the saffron investigation product (chlorophyll capsules).

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Perceived Stress Scale	Baseline (day -7 and day 0) and day 42 (end of the study)	Questionnaire, score 0-40, higher score = worse
Wake after sleep onset	Baseline (from day -7 to day 0), third week (from day 14 to day 21), last week (from day 35 to 42)	Actimetry
Short Form (36) Health Survey	Baseline (day -7 and day 0) and day 42 (end of the study)	Questionnaire, score 0-100, higher score = better
Epworth Sleepiness Scale	Baseline (day-7 and day 0), day 21 and day 42 (end of the study)	Questionnaire, score 0-24, higher score = worse
Fragmentation index	Baseline (from day -7 to day 0), third week (from day 14 to day 21), last week (from day 35 to 42)	Actimetry
Time in bed	Baseline (from day -7 to day 0), third week (from day 14 to day 21), last week (from day 35 to 42)	Actimetry
Change from baseline Leeds Sleep Evaluation Questionnaire score at 21 days	Baseline (day -7 and day 0) and day 21	Questionnaire, score 0-100, higher score = better
Pittsburgh Sleep Quality Index	Baseline (day -7 and day 0) and day 42 (end of the study)	Questionnaire, score 0-21, higher score = worse
Actual sleep time	Baseline (from day -7 to day 0), third week (from day 14 to day 21), last week (from day 35 to 42)	Actimetry
Sleep onset latency	Baseline (from day -7 to day 0), third week (from day 14 to day 21), last week (from day 35 to 42)	Actimetry
Sleep efficiency	Baseline (from day -7 to day 0), third week (from day 14 to day 21), last week (from day 35 to 42)	Actimetry

Trial Locations

Locations (1)

UCLouvain - CICN; 🇧🇪 Louvain-La-Neuve, Belgium