Increasing daytime sleepiness and declining cognitive performance throughout the day
Conditions
Interventions
Group 1: Multi-nutrient direkt stick with a single dosis of 160 mg Caffeine, 20 mg Ginseng extract, 150 mg Taurin, 50 mg L-arginine, 150 mg Magnesium, 41,5 mg Potassium, 3,25 mg Zinc, 80 mg Vitamin C,
Sponsors
Apomedica Pharmazeutische Produkte GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: • Males or females (at least 1/3 (6 participants) of each gender) • BMI: 19.0 – 35.0 kg/m² • Able and willing to give written informed consent • Normal or corrected visual acuity • Normal pupil response • Willing to wear no or subtle make-up, preferably without mascara or false eyelashes • Willing to maintain consistent bedtime the evenings before study visits • If applicable, stable intake of chronic medication of at least 4 weeks not interfering with the study (e.g. L-Thyroxin, antihypertensives, etc.)
Exclusion criteria
Exclusion criteria: • Participants with no regular caffeine consume or caffeine consume of > 200 mg/day • Known eye diseases with impairment of pupil function (e.g. iris atrophy, glaucoma, condition after eye surgery) • Pharmacological mydriasis • Current or past diagnosis of a major cognitive disorder (e.g. Alzheimer’s Disease or Parkinson’s Disease) or confirmation of a mini stroke (TIA) within the last 3 months • Diabetes mellitus (type I and type II) • Uncontrolled hypertension (SBP > 160 mmHg and/or DBP >100 mmHg) • A significant CVD event within last 3 mo. incl. myocardial infarction, stroke, congestive heart failure • Presence (or past history of) significant psychiatric disorders (severe anxiety, major depression, panic disorder, etc.). • History of head trauma, neurological deficits • Chronic use of any antidepressant drugs (e.g. Amitriptylin, Citalopram, Duloxetin, Escitalopram, Fluoxetin, Mirtazapin, Sertralin, Venlafaxin) in the last 12 months • Use of sleep aids (e.g. Diazepam, Melatonin), sedatives (e.g. Benzodiazepine) or sleeping pills (e.g. Melatonin) within 3 months prior to study start or during study • Other regular intake of drugs or supplements possibly interfering with this study (e.g. opiates, systemic glucocorticoids, anti-histamines, neuroleptics, etc.) within 3 months prior to study start or during study • Regular use of supplements (incl. vitamins and minerals) with known cognitive enhancing effects (e.g. ginseng, ginkgo, caffeine, methylphenidate, modafinil, amphetamine, cholinesterase inhibitors, memantine etc.). A stable dose of vitamin D for at least 3 months will be allowed. • Smokers or participants who use vape products • Shift worker or major circadian disruption, e.g. jet lag • Known sleep apnea • Unable to sit 11 minutes quietly in a dark room • Consumption of more than the recommended alcohol guidelines of >14 units/week for males and females considering a unit with 10 g alcohol • Inability to complete or understand the cognitive function tests • Red-green color blindness • Relevant allergy or known hypersensitivity against compounds of the study product • Known pregnancy, breastfeeding or intention to become pregnant during the study. A pregnancy test will be conducted during screening and visit 2 and 3 at the study site • Participation in another clinical study within the last 4 weeks and concurrent participation in another clinical study • Participants considered inappropriate for the study by investigators, including participants who are unable or unwilling to show compliance with the protocol • Participants not able to follow study procedures and/or tests, e.g. due to language problems or mental /psychological disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The pupillary unrest index (PUI) will be evaluated by a pupillographic sleepiness test (PST) at timepoints 0h (baseline) and 1h, 2h, 3h, 4h and 5h after product intake. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Subjective assessment of sleepiness by Stanford Sleepiness Scale (SSS) and Visual Analog Scale (VAS) on sleepiness (timepoints 0h, 1h, 2h, 3h, 4h, 5h) - Cognitive test battery (timepoints 0h, 2.5h and 4.5h) | — |
Countries
Germany
Contacts
Public ContactChristiane Schön
BioTeSys GmbH
Outcome results
None listed