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Effect of a plant extract containing dietary supplement on psychopathologic stress reactions among healthy participants

Organizational Data

DRKS-ID:
DRKS00006008
Recruitment Status:
Recruiting complete, study complete
Date of registration in DRKS:
2014-04-09
Last update in DRKS:
2024-03-13
Registration type:
Prospective

Acronym/abbreviation of the study

SB-SID 0213

URL of the study

No Entry

Brief summary in lay language

Stress is defined as physical and / or psychological stress over a long period. Stress-associated clinical symptoms which may be obvious in stressed populations are fatique, exhaustion or depression. e.g.. Stress affects organ systems and can even enhance nutrient deficits. Aim of this study is to evaluate the effect of a dietary supplement with a plant extract with Sideritis scardica and selected vitamins (Vitamin B1, B6, B12, folic acid) on the stress tolerance among 60 healthy study participants. The dietary supplements are given for 6 weeks. At time t0 and t6, stress tolerance is monitored by cognitive tests as well as by blood and saliva. Health status is assessed, too.

Brief summary in scientific language

Stress is defined as physical and / or psychological stress over a long period. Stress-associated clinical symptoms are fatique, exhaustion or depression. e.g.. Stress situations not only affect organ systems but also enhance nutrient deficits. Aim of this study is to evaluate the effect of a dietary supplement with a plant extract with Sideritis scardica and selected vitamins (Vitamin B1, B6, B12, folic acid) on the stress tolerance of the study participants.

Health condition or problem studied

Free text:
STRESS
Free text:
Healthy volunteers
Healthy volunteers:
Yes

Interventions, Observational Groups

Arm 1:
Over a period of six weeks, study participants ingests twice daily one capsule. Main ingredients of this capsules are vitamines (B1, B6, B12, Folic acid) and a plantextract of Sideritis scardica.

Endpoints

Primary outcome:
Stress tolerance (six weeks after first examination (t6) in comparison to first examination (t0)), respectivly measured as changes of the cognitive performance and visual attentnion under stress, using the Trail Making Test (TMT), before and after an acute stress impulse.
Secondary outcome:
• stress tolerance (six weeks after first examination (t6) in comparison to first examination (t0)), respectively measured by changes in the cognitive performance and visuell attention in the Colour Word Test (CWT) (Duration: 10 minutes) • subjective stress perception (six weeks after first examination (t6) in comparison to first examination (t0)) (according to the Perceived Stress Questionnaire) • acute subjective stress perception (six weeks after first examination (t6) in comparison to first examination (t0)) (according to General Stress Questionnaire) before and after an acute stress impulse.

Study Design

Purpose:
Basic research/physiological study
Allocation:
N/A (single arm study)
Control:
  • Uncontrolled/single arm
Phase:
N/A
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
No
Assignment:
Single (group)
Sequence generation:
No Entry
Who is blinded:
No Entry

Recruitment

Recruitment Status:
Recruiting complete, study complete
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Monocenter study
Recruitment location(s):
  • Other Institut für Lebensmittelwissenschaft und Humanernährung Universität Hannover, Institut für Lebensmittelwissenschaft und Humanernährung, Abteilung: Ernährungsphysiologie und Humanernährung, Hannover

Recruitment period and number of participants

Planned study start date:
2014-04-11
Actual study start date:
2014-04-11
Planned study completion date:
No Entry
Actual Study Completion Date:
2014-12-12
Target Sample Size:
60
Final Sample Size:
65

Inclusion Criteria

Sex:
All
Minimum Age:
25 Years
Maximum Age:
60 Years
Additional Inclusion Criteria:
• Age: 25-60 years • Men and Women • Non-smokers • written consent after information about study contents and study procedure • Ability and willingness of study participants to follow study leaders instructions

Exclusion Criteria

• severe chronic illness (manifest coronary heart disease, cancer, • insulin-dependent diabetes mellitus Typ I and II), severe kidney or liver diseases • Psychological diseases (ADHS, Depression, panic, anxiety) • food allergies, known endokrine and immunological diseases • chronic gastroinestinal diseases (especially small intestine e.g. duodenal ulcer, liver, pancreas) and state after gastrointestinal surgical procedure e.g. nontropical sprue, short bowel syndrome), stomach stapling operations, gastric band • oral mucositis, dental diseases, inflammation in the oral cavity • Hormonal disorders, for example, hyperthyroidism and Cushing's syndrome • heart surgery (Stent, Bypass, Heart pacemaker/ gastrointestinal surgery (not: elimination of appendix or gall bladder) • • immediate planned surgery • addiction to alcohol and/or drugs • Pregnancy, lactation • Smokers • Persons with body mass index > 30 • Persons who are not able or not allowed to give written consent • simultaneous participation at another clinical trial or participation within the last 30 days

Addresses

Primary Sponsor

Schaper & Brümmer GmbH & Co. KG
Bahnhofstraße 35
38259 Salzgitter
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
No

Contact for Scientific Queries

Institut für Lebensmittelwissenschaft und Humanernährung
Dr. Isabel Behrendt
Am Kleinen Felde 30
30167 Hannover
Germany
Telephone:
0511 762 3317
Fax:
0511 762 5729
Contact per E-Mail
URL:
http://www.nutrition.uni-hannover.de/nutrition.html

Contact for Public Queries

Institut für Lebensmittelwissenschaft und Humanernährung
Dr. Isabel Behrendt
Am Kleinen Felde 30
30167 Hannover
Germany
Telephone:
0511 762 3317
Fax:
0511 762 5729
Contact per E-Mail
URL:
http://www.nutrition.uni-hannover.de/nutrition.html

Principal Investigator

Institut für Lebensmittelwissenschaft und Humanernährung
Dr. Isabel Behrendt
Am Kleinen Felde 30
30167 Hannover
Germany
Telephone:
0511 762 3317
Fax:
0511 762 5729
Contact per E-Mail
URL:
http://www.nutrition.uni-hannover.de/nutrition.html

Sources of Monetary or Material Support

Commercial (pharmaceutical industry, medical engineering industry, etc.)

Schaper & Brümmer GmbH & Co. KG
Bahnhofstraße 35
38259 Salzgitter
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Ethikkommission bei der Ärztekammer Niedersachsen, Unterkommission zur Beurteilung medizinischer Forschung am Menschen
Karl-Wiechert-Allee 18-22
30625 Hannover
Germany
Telephone:
+49-511-3802208
Fax:
+49-511-3802119
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2014-02-10
Ethics committee number:
Bo/07/2014
Vote of the Ethics Committee:
Approved
Date of the vote:
2014-03-10

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
2016
Publikationen/Studienergebnisse:
Studienergebnisse
Behrendt et al. International Journal of Phytomedicine 8 (2016) 95-103
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
2024-03-13

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry