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

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.

Study Overview

• Status: Completed
• Conditions: Stress; Insomnia
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Saffron

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 Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Louvain-La-Neuve, Belgium, 1348
    • UCLouvain - CICN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Control; Each capsule contained 275mg of maltodextrin. Capsules were similar to the saffron investigation product (chlorophyll capsules).	Dietary supplement: Placebo; Subjects orally ingested, with water, one capsule per day (in the evening)
EXPERIMENTAL: 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%).	Dietary supplement: Saffron; Subjects orally ingested, with water, one capsule per day (in the evening)

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Comercial Quimica Masso, S.A
• Collaborators: Université Catholique de Louvain
• Investigators: Principal Investigator: Sylvie Copine, Dr, Université Catholique de Louvain

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 12, 2019
• Primary Completion (ACTUAL): November 3, 2020
• Study Completion (ACTUAL): November 3, 2020

Study Registration Dates

• First Submitted: January 28, 2021
• First Submitted That Met QC Criteria: February 10, 2021
• First Posted (ACTUAL): February 11, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 11, 2021
• Last Update Submitted That Met QC Criteria: February 10, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: Saffractiv2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No