acute and chronic stress
Conditions
Interventions
Group 1: Lactium capsules contain 300mg Lactium (alphaS1-casein tryptic hydrolysate), 100mg maltodextrin, 7mg magnesium stearate, 3mg silica. Capsules are made of gelatine. Intake instructions: One ca
Sponsors
Ingredia SA
Eligibility
Sex/Gender
All
Age
20 Years to 60 Years
Inclusion criteria
Inclusion criteria: 20 - 60 years old; pre-menopausal women have to be on hormonal contraception (for 3 months or more);
Exclusion criteria
Exclusion criteria: - Smoking more than 5 cigarettes per day; - Known allergies to ingredients of the test substances; - Known addiction to drugs and/or alcohol; - Hyper- or hypotension (systolic > 140 or 90 or < 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); - Has taken dietary supplements or homoeopathic remedies in the two weeks prior to the first visit; - Is on a strikt diet or practices sport, extensively; - Any other current/acute diseases besides minor medical conditions (e.g. seasonal allergies); - Perceived pathologically anxious subjects; - Subjects having previously participated in the TSST; - Subjects working on nightshift; - Pregnant or lactating females or females planning pregnancy within the next 3 months; - Post-menopausal women using hormonal medication for less than 3 months; - Employee of the sponsor or CRO.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to evaluate the efficacy of a daily intake of 300mg Lactium over a period of 4 weeks on subjectively perceived stress during an acute stressful situation as compared to a control product. Efficacy is defined as a lower increase in the Visual Analog Scale Stress of the test group in response to the Trier Social Stress Test as compared to the control group. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives of this study are to evaluate the efficacy of a daily intake of 300mg Lactium over a period of 4 weeks as compared to a control product on - chronic stress levels as measured by the stress subscale of the Depression-Anxiety-Stress-Scales, assessed on visits 2, 3 and 4; efficacy is defined as a decrease in stress scores; - the dynamic of the post awakening cortisol secretion measured by the area under the curve with respect to the increase (AUCi), measured on two workdays before visit 2 and two workdays before visit 4; efficacy is defined as a decrease in the AUCi - anxiety as measured by the Visual Analog Scale (VAS) Anxiety during an acute stressful situation, measured on visit 4 before, during and after the Trier Social Stress Test (TSST); efficacy is defined as a lower increase in the VAS anxiety scale in response to the TSST - insecurity as measured by the VAS insecurity scale during an acute stressful situation, measured on visit 4 before, during and after the TSST; efficacy is defined as a lower increase in the VAS insecurity scale in response to the TSST - stress as measured by the VAS stress scale over visits, assessed on visits 2, 3 and 4; efficacy is defined as a decrease in the VAS stress scale - salivary cortisol during an acute stressful situation, assessed on visit 4 2 minutes before and 1, 10, 20, 30 and 45 minutes after the TSST; efficacy is defined as a lower increase in cortisol raw values in response to the TSST - Heart Rate during an acute stressful situation, assessed on visit 4 continuously starting 20 minutes before TSST and ending 20 minutes after TSST; efficacy is defined as a lower increase in HR in response to the TSST - Blood pressure during an acute stressful situation, assessed on visit 4 every 5 minutes starting 20 minutes before the TSST and ending 5 minutes after the TSST; efficacy is defined as a lower increase in blood pressure in response to the TSST - state anxiety as measured by the State-Trait-Anxiety-Inven | — |
Countries
Germany
Contacts
Public ContactNicole Weber
daacro GmbH & Co. KG
Outcome results
None listed