Effects of a Sage Extract on Cognitive Function in Adolescents and Young Adults – an explorative randomized, double-blind, placebo-controlled clinical study.
- Conditions
- Effects on Cognitive Function Healthy subjects
- Registration Number
- DRKS00015716
- Lead Sponsor
- Sibelius Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 73
healthy male and female individuals
- age group A: 12-14 years
- age group B: 18-25 years
- willing to participate and signed informed consent
- 12-14 year olds: legal representative signed informed consent
- speaks German fluently
- able to understand the background and the purpose of the study, including possible risks and side-effects
- willing to comply with the protocol and the study specific limitations
- any known current/acute or chronic physical or psychological diseases (e.g. attention deficit (hyperactivity) disorder (AD(H)D), anxiety disorders, diabetes) besides minor medical conditions (e.g. seasonal allergies)
- hypotension (systolic < 100; diastolic < 60) (except for those whose blood pressure is stable using medication for more than 3 months)
- known hyper- or hypothyroidism unless treated and under control (stable for more than 3 months)
- intake of any medication during 4 weeks before Visit (V) 1 and during study conduction, which may affect the cognitive performance (e.g. psychotropics, sedating or stimulating medication)
- intake of dietary supplements or homoeopathic remedies during 2 weeks before V1 and during the study conduction
- females pregnant or lactating or planning a pregnancy during study conduction
- known dyslexia
- any known vision impairment not corrected by glasses, contact lenses, etc.
- any known addiction to drugs and/or alcohol
- excessive caffeine consumption (>400 mg caffeine/day or =4 cups of caffeinated coffee)
- intake of illegal drugs during 3 weeks before V1 and during study conduction (e.g. cannabis, cocaine)
- any known allergies to the IP or placebo
- smoker
- on a strict diet or practicing sport, extensively
- employee of the sponsor or CRO
- Investigator doubts truthfulness of self-reported health information
- Current participation in another clinical study
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of this study is to evaluate the efficacy of the intake of 1 x 150 mg of S. officinalis on memory performance as compared to a placebo product in 12-14 year olds, and to evaluate the efficacy of the intake of 1 x 150 mg and of 1 x 300 mg of S. officinalis on memory performance as compared to a placebo product in 18-25 year olds. Efficacy is defined as an increased accuracy in the CogTrack™ Pattern Separation (1h and 2.5hrs after product administration as compared to baseline) task as compared to a placebo product.
- Secondary Outcome Measures
Name Time Method