Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00005125

Trial Description

start of 1:1-Block title

Title

Effects of a Soy Lecithin Phosphatidylserine/ Phosphatidic Acid Complex (PAS) on Stress Reactivity in an Acute Stressful Situation (TSST – Trier Social Stress Test): a Randomized, Placebo – Controlled Single Center Study

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

PAS and Stress

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

The aim of this study is to investigate the effect of a nutritional supplement [Soy Lecithin phosphatidylserine/ Phosphatidic Acid Complex (PAS)] as compared to placebo on stress.
A total of 75 healthy non-smoking men aged 20-45 years take PAS/Placebo capsules for 42 consecutive days before finally taking part in a stress test. Stress will be assessed by means of questionnaires, measurements of heart rate and stress hormones in both the saliva and blood.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

This is a randomized, double-blinded, placebo–controlled single–center study involving three treatment arms (placebo, 200 mg/day PAS, 400 mg/day PAS) in 75 non-smoking healthy men aged 20-45 years (25 subjects in each arm).
Subjects are randomly allocated to a treatment arm and administered 4 treatment capsules daily. Study Design: In total 4 study visits take place per subject. Subjects will be screened at V1 and if eligible will be included in the study at V2. At V2 the study participants will be randomly assigned to a treatment arm, complete baseline psychometric questionnaires to assess the chronic stress (Trier Inventory for Chronic Stress) and receive treatment supply. After 21 days of treatment, the subjects return to the study site (V3) and complete further stress questionnaires (Perceived Stress Scale and Depression Anxiety Stress Scales). V4 occurs after 42 days of treatment and the involves the completion of questionnaires, collection of physiological parameters and the TSST.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00005125
  •   2013/08/26
  •   [---]*
  •   no
  •   Approved
  •   837.542.12, Ethik-Kommission bei der Landesärztekammer Rheinland-Pfalz
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Stress-related impairments
  •   Healthy Volunteer
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   PAS (Soy Lecithin Phosphatidylserine/Phosphatidic Acid Complex), 400 mg/day p.o. (capsules), for 42 days
  •   PAS (Soy Lecithin Phosphatidylserine/Phosphatidic Acid Complex), 200 mg/day p.o. (capsules), for 42 days
  •   Placebo, for 42 days
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist
  •   Placebo, Active control (effective treament of control group)
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

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).

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

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)

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • other 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2013/01/16
  •   75
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Male
  •   20   Years
  •   45   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Healthy non–smoking male volunteers aged 20–45 years.

end of 1:1-Block inclusion criteria add
start of 1:1-Block 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.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Lonza Ltd. (Scientific Marketing, Nutrition)
    • Ms.  Ulla  Freitas 
    • Muenchensteinerstrasse 38
    • 4002  Basel
    • Switzerland
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • DAaCRO GmbH & Co. KG
    • Ms.  Juliane  Hellhammer 
    • Max-Plank-Straße 22
    • D-54296  Trier
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • DAaCRO GmbH & Co. KG
    • Ms.  Nadine  Franz 
    • Max-Plank-Straße 22
    • D-54296  Trier
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    •   +49 (0) 651 9120-494
    •   +49 (0) 651 9120-564
    •   franz at daacro.de
    •   [---]*
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Lonza Ltd.; Scientific Marketing, Nutrition
    • Ms.  Ulla  Freitas 
    • Muenchensteinerstrasse 38
    • 4002  Basel
    • Switzerland
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2013/07/02
end of 1:1-Block state
* This entry means the parameter is not applicable or has not been set.