Effect of a saffron extract on sleep parameters in healthy adults with poor sleep: a randomized, double blind, 3 arm, placebo-controlled clinical study.
- Conditions
- Healthy subjects with self-reported poor sleep
- Registration Number
- DRKS00033435
- Lead Sponsor
- Gottfried Wilhelm-Leibniz-Universität Hannover Institut für Lebensmittelwissenschaft und Humanernährung
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 165
Regensburg Insomnia Scale score > 12
- No concomitant dietary, pharmacological or psychological treatment for sleep disorder
- BMI 20 and 35 mg/m²
- Typical bedtime between 9 p.m. and 12 a.m.
- Ability and willingness of the study participants to follow the instructions of the investigator. This includes compliance with the study conditions, regular consumption of the tested supplement, adherence to provided dietary recommendations, consistent use of actigraphy devices (such as Fitbit watches) and agreement to provide data from these devices for analysis (which will be conducted anonymously)
- Willingness to consume 1 capsule of a saffron extract per day 1 hour before bedtime
- Written informed consent of the subjects after detailed written explanation of the study content, requirements and risks
Lifestyle and Occupational Factors:
- Occupational Sleep Disruption: Night or rotational shift workers.
- External Sleep Disruptors: Affected by factors like awakenings by infants, noise, snoring partners, or chronic pain.
- Caffeine Consumption: =4 cups of coffee or caffeine drinks or equivalent per day and no caffeine consumption after 4pm
- Alcohol Intake: >14 standard drinks weekly.
- Illicit Drug Use: Current or past-year history.
- Tobacco/Nicotine: Individuals who smoke more than 5 cigarettes per day or consume an equivalent amount of nicotine through other means on a daily basis are excluded from participation.
- Upcoming surgery or travel: Individuals with surgeries or travel (including jetlag) planned within the next three months.
Medical and Health Conditions:
- Specific Sleep Disorders: Diagnosed sleep disorders (e.g. sleep apnea) excluding psychophysiological insomnia.
- Prolonged Sleep Disturbance: Chronic disturbances >1 year.
- Mental Health disorders: Diagnosed mental health disorders excluding mild depressive/anxiety symptoms (PHQ-4).
- Medical Conditions: Diagnosed chronic diseases like diabetes, hypertension, cardiovascular disease, gastrointestinal disorders, gallbladder issues, endocrine disorders, psychiatric conditions, neurological diseases, cancer, or chronic pain.
- Reproductive Status: Pregnant, breastfeeding, or intention to become pregnant during the study
- Oral Health Issues: Infections, diseases, or recent surgeries.
Medication and Supplements:
- Antidepressants and other psychotropic medicines
- Ongoing Sleep Treatments: Undergoing treatments like cognitive behavioral therapy, relaxation therapy, psychotherapy.
- Supplement Use: Regular use of sleep-affecting supplements such as magnesium or valerian.
- Anticoagulant Medications: Subjects being on blood-thinners due to saffron's potential blood thinning properties.
- Recent Medication and Supplement Alterations: Individuals who have made changes to their medication or supplement intake within the past 2 months.
- Allergies/Antihistamines: Needing antihistamines due to sedative effects.
- Laxative Usage: Regular intake of laxatives.
- Medications reducing saliva production (salivary sampling)
Dietary and Consumption Patterns:
- Regular consumption of large amounts of saffron
- Saffron Allergy: Allergic to saffron or other components of the capsules
Actigraphy (Fitbit Devices):
- Skin Conditions: Conditions exacerbated by wristbands, e.g., eczema.
- Physical Limitations: Disabilities preventing device usage
- Unwillingness/Inability to wear and synchronize the device: The devices need to be worn at night and it is necessary to synchronise the Data via a FitBit-Account.
Legal/ Regulatory Restrictions: Under legal protection or deprived rights.
Participation in another clinical study currently or in the previous 3 months.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Total Score of the Athens Insomnia Scale (AIS)<br>Time Points: t0, t28<br>Method: Self-Assessment
- Secondary Outcome Measures
Name Time Method