Effects on Cognitive Function Healthy subjects
Conditions
Interventions
Group 1: 18-25 year olds:
single dose, 1 capsule 300mg S. officinalis L. extract
Group 2: 12-14 year olds:
single dose, 1 capsule 150mg S. officinalis L. extract
18-25 year olds:
single dose, 1 c
Sponsors
Sibelius Limited
Eligibility
Sex/Gender
All
Age
12 Years to 25 Years
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 1) The effects of S. officinalis L. extract on further cognitive functions are evaluated with cognitive tests from the "CogTrack Test System" (Wesnes Cognition). On the second study visit, two training sessions with a ten-minute break will be held to prevent a possible training effect. On the third study day, the day of product /placebo ingestion, three test units are performed at 25 minutes before and 1 hour and 2.5 hours after IP / placebo. The duration of the respective tests amounts to approx. 20 minutes. 2) The effects of S. officinalis L. extract on mood are recorded six times with the self-assessment manikin (SAM) questionnaire on the third appointment. It is requested at 35 and 5 minutes prior to product intake and 50, 80, 140 and 170 minutes after product intake. 3) The effects of S. officinalis L. extract on perceived stress, anxiety and exhaustion are recorded six times via a Visual Analogue Scale (VAS) on the third date. On a scale from "not at all" to "strong", the state of stress, anxiety and exhaustion can be stated. This query is collected at 35 and 5 minutes prior to product intake and 50, 80, 140 and 170 minutes after product intake. 4) The effects of S. officinalis L. extract on biomarkers should be evaluated. At the third appointment a total of six saliva samples will be collected. Of these, salivary cortisol is detected at 35 and 5 minutes prior to product intake and 50, 80, 140 and 170 minutes after product intake. Salivary acetylcholinesterase (AChE) activity is recorded at times 35 before product intake and 50, 80, 140 minutes after product intake. And the salivary oxytocin 35 before product intake and 80 minutes after product ingestion. The heart rate (HR) and blood pressure (BP) are recorded once on the first and second appointments. At the third appointment, the measurements will be made at 65, 35 and 5 minutes before product intake and 50, 80, 140 and 170 minutes after product intake. | — |
Countries
Germany
Contacts
Public ContactJuliane Hellhammer
daacro GmbH & Co. KG
Outcome results
None listed