The Effects of Dietary Factors on Physiological Subjective Stress Responses (AivoPro2)

This study has been completed.

Sponsor:

Collaborator:

SalWe Ltd

Information provided by (Responsible Party):

Katri Peuhkuri, Helsinki University

ClinicalTrials.gov Identifier:

NCT01544270

First received: February 16, 2012

Last updated: April 24, 2013

Last verified: April 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	February 16, 2012
Last Updated Date	April 24, 2013
Start Date ^ICMJE	September 2011
Primary Completion Date	March 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 28, 2012)	Subjective well-being [ Time Frame: baseline and 4 weeks ] [ Designated as safety issue: No ] Change in stress and mood states measured by State-trait anxiety inventory (STAI) and modified Profile of Mood States (POMS) at baseline and after 4 wk intervention
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01544270 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 28, 2012)	Physiological measurements [ Time Frame: baseline and 4 weeks ] [ Designated as safety issue: No ] Change in salivary cortisol, blood pressure, heart beat variability, sleep and inflammatory markers.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	The Effects of Dietary Factors on Physiological Subjective Stress Responses
Official Title ^ICMJE	The Effects of Dietary Factors on Physiological Subjective Stress Responses in Cronically Stressed Subjects: a Randomised Clinical Trial
Brief Summary	The study aims to investigate the role of dietary factors in chronically stressed subjects. Previous studies have shown that milk proteins, B vitamins and probiotics may influence on subjective well-being in stressed subjects.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Basic Science
Condition ^ICMJE	Chronic Stress
Intervention ^ICMJE	Dietary Supplement: Yogurt-like snacks twice a day 120 g for four weeks
Study Arm (s)	Active Comparator: Study product containing milk proteins Yoghurt-like milk-based product Intervention: Dietary Supplement: Yogurt-like snacks Active Comparator: Study product containing probiotics Yoghurt-like milk-based product Intervention: Dietary Supplement: Yogurt-like snacks Placebo Comparator: Control product Yoghurt-like milk-based product without supplemented nutrients Intervention: Dietary Supplement: Yogurt-like snacks
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	101
Completion Date	September 2012
Primary Completion Date	March 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: STAI points 40-65 BMI 18-30 kg/m2 healthy Exclusion Criteria: Gastrointestinal disease, diabetes or any other significant major medical morbidity milk allergy smoking excess use of alcohol pregnancy and breast feeding waist circumference males >102 cm, females >88 cm no medication or dietary supplements influencing measured responses
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Finland

Administrative Information
NCT Number ^ICMJE	NCT01544270
Other Study ID Numbers ^ICMJE	UH-SHOK-002
Has Data Monitoring Committee	No
Responsible Party	Katri Peuhkuri, Helsinki University
Study Sponsor ^ICMJE	Helsinki University
Collaborators ^ICMJE	SalWe Ltd
Investigators ^ICMJE	Not Provided
Information Provided By	Helsinki University
Verification Date	April 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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