Healthy Students
Conditions
Interventions
Group 1: Eight-week supplementation with Ashwagandha root extract among students of Trier University of Applied Sciences.
Sponsors
Naturafit Produktions GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Enrolment as a student at Trier University of Applied Sciences Sufficient proficiency in the German language to comprehend study-related information and questionnaires Provision of written informed consent prior to study participation Willingness to participate in the study intervention in accordance with the study protocol (daily supplementation with Ashwagandha root extract over a period of 8 weeks) Willingness to participate in all study-related assessments, including questionnaires as well as saliva and urine sample collection
Exclusion criteria
Exclusion criteria: Age below 18 years Existing pregnancy or breastfeeding* Presence of acute or chronic diseases Current use of medication** Use of zinc-containing dietary supplements that cannot be discontinued for the duration of the study (e.g., additional zinc supplements or multivitamin preparations containing zinc) Known allergy or intolerance to any ingredient of the dietary supplement used in the study Concurrent participation in another clinical or nutritional science study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is the change in perceived stress levels, assessed using the Perceived Stress Scale (PSS-10), between baseline and study completion following eight weeks of supplementation with Ashwagandha root extract (300 mg/day). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints comprise changes in physiological and psychological stress-related parameters between baseline and the end of the intervention period: • Salivary cortisol concentration (nmol/L): Salivary cortisol will be assessed as an established non-invasive biomarker reflecting activation of the hypothalamic–pituitary–adrenal (HPA) axis. • Urinary cortisol excretion: Free cortisol concentrations in 24-hour urine samples will be determined (µg/24 h or nmol/24 h). • Urinary catecholamines: Stress-associated catecholamines, including urinary adrenaline (epinephrine) and noradrenaline (norepinephrine), will be quantified in 24-hour urine samples (µg/24 h). • Stress coping capacity: Changes in stress coping will be evaluated using the Stress and Coping Inventory (SCI). | — |
Countries
Germany
Contacts
Public ContactChristina Heidt
Hochschule Trier
Outcome results
None listed