Stress-related impairments Healthy Volunteer
Conditions
Interventions
Group 1: PAS (Soy Lecithin Phosphatidylserine/Phosphatidic Acid Complex), 400 mg/day p.o. (capsules), for 42 days
Group 2: PAS (Soy Lecithin Phosphatidylserine/Phosphatidic Acid Complex), 200 mg/day p
Sponsors
Lonza Ltd. (Scientific Marketing, Nutrition)
Eligibility
Sex/Gender
Male
Age
20 Years to 45 Years
Inclusion criteria
Inclusion criteria: Healthy non–smoking male volunteers aged 20–45 years.
Exclusion criteria
Exclusion criteria: Known allergies to ingredients of the test product; addiction to nicotine, drugs or alcohol; change in nutritional habits (start of a weight loss diet, overconsumption of caffeine); serious general illness, ongoing or within the last 12 months; febrile illness (> 24 h) within 7 days prior to assessment; antibiotics for the last four weeks before study inclusion; any known diseases as diabetes mellitus, heart disease, hypertension, kidney disease, significant respiratory disease, or epilepsy; any known immunologic or infectious disease (e.g. hepatitis, tuberculosis, HIV or AIDS, lupus, rheumatoid arthritis) which could place the subject at risk or interfere with the accuracy of the study results; current or past participation in a TSST study; employees of the Sponsor or the CRO; other medication that, in the opinion of the Investigator is likely to affect their response to treatment; other condition the Investigator or their duly assigned representatives believes may affect the ability of the individual to complete the study or the interpretation of the study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Primary aim of the study is to assess the effects of two PAS dosages as compared to placebo on stress-induced saliva cortisol levels with regards to chronic stress level assessed through the Trier Inventory for Chronic Stress (TICS). After treatment for 42 consecutive days, saliva samples are collected from subjects during the TSST at the following intervals: 2 minutes prior to TSST and 1, 10, 20, 30 and 60 minutes post TSST. The salivary cortisol levels are then determined using a competitive solid phase time-resolved fluorescence immunoassay with fluorometric end point detection (DELFIA)(Dressendörfer et al., 1992). | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives of the study are to investigate the effects of the two PAS dosages as compared to placebo on general stress perception and the psychobiological stress response to the TSST with regards to chronic stress level. The secondary outcome parameters are as follows: 1) General stress levels a) Questionnaire: Trier Inventory for Chronic Stress (TICS) - at study enrolment (V1), and V4 b) Questionnaire: Perceived Stress Scale (PSS) - at V2, V3 and V4 c) Questionnaire: Depression and Anxiety Stress Scales (DASS) - at V2, V3 and V4 2) Mood before and after the TSST a) Questionnaire: Multidimensional Mood State Questionnaire (MBDF) - at V4 b) Questionnaire: Profile of Moods States (POMS) - at V4 3) Stress Perception, anxiety and insecurity in relation to the TSST a) Questionnaire: Visual Analogue Scales (VAS)- at V4 b) Questionnaire: State-Trait Anxiety (STAI-X1) - at V4 4) Serum Cortisol and Adrenocorticotropic Hormone (ACTH) levels in reponse to the TSST - at V4 a) Serum Cortisol in parallel to Saliva Cortisol sampling 1x pre-TSST and 5x post-TSST b) ACTH 1x pre-TSST and 1x post-TSST 5) Cardiovascular Response to the TSST - at V4 (pre-, during-, post TSST; total of 55 min) a) Heart Rate b) Low frequency/High frequency (LF/HF) c) Pulse and Transit Time (PTT) 6) Electrodermal activity (EDA) - at V4 (pre-, during-, post TSST) | — |
Countries
Germany
Contacts
Public ContactNadine Franz
DAaCRO GmbH & Co. KG
Outcome results
None listed