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

Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04750681
• Other study ID #: Saffractiv2019
• Status: Completed
• Phase: N/A
• Start date: August 12, 2019
• Est. completion date: November 3, 2020

Study information

• Verified date: January 2021
• Source: Comercial Quimica Masso, S.A
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders
• Stress

Intervention

Dietary Supplement:
• Placebo
Subjects orally ingested, with water, one capsule per day (in the evening)
• Saffron
Subjects orally ingested, with water, one capsule per day (in the evening)

Locations

Country	Name	City	State
Belgium	UCLouvain - CICN	Louvain-La-Neuve

Sponsors (2)

Lead Sponsor	Collaborator
Comercial Quimica Masso, S.A	Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

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)