Status:
COMPLETED
Evaluation of the Effects of Saffron Extract on Sleep Quality and Stress
Lead Sponsor:
Comercial Quimica Masso, S.A
Collaborating Sponsors:
Université Catholique de Louvain
Conditions:
Insomnia
Stress
Eligibility:
All Genders
25-70 years
Phase:
NA
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 m...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 3 2020
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT04750681
Start Date
August 12 2019
End Date
November 3 2020
Last Update
February 11 2021
Active Locations (1)
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1
UCLouvain - CICN
Louvain-la-Neuve, Belgium, 1348