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

NCT ID: NCT04750681

Last Updated: 2021-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-12
• Study Completion Date: 2020-11-03

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.

Conditions

Insomnia; Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Control

Each capsule contained 275mg of maltodextrin. Capsules were similar to the saffron investigation product (chlorophyll capsules).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Subjects orally ingested, with water, one capsule per day (in the evening)

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%).

Group Type: EXPERIMENTAL

Saffron

Intervention Type: DIETARY_SUPPLEMENT

Subjects orally ingested, with water, one capsule per day (in the evening)

Interventions

Placebo

Subjects orally ingested, with water, one capsule per day (in the evening)

Intervention Type: DIETARY_SUPPLEMENT

Saffron

Subjects orally ingested, with water, one capsule per day (in the evening)

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Université Catholique de Louvain

OTHER

Sponsor Role: collaborator

Comercial Quimica Masso, S.A

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sylvie Copine, Dr

Role: PRINCIPAL_INVESTIGATOR

Université Catholique de Louvain

Locations

UCLouvain - CICN

Louvain-la-Neuve, , Belgium

Countries

Belgium

Other Identifiers

Saffractiv2019

Identifier Type: -

Identifier Source: org_study_id