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

February 16, 2012
April 24, 2013
September 2011
March 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01544270 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
The Effects of Dietary Factors on Physiological Subjective Stress Responses
The Effects of Dietary Factors on Physiological Subjective Stress Responses in Cronically Stressed Subjects: a Randomised Clinical Trial

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Chronic Stress
Dietary Supplement: Yogurt-like snacks
twice a day 120 g for four weeks
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
101
September 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT01544270
UH-SHOK-002
No
Katri Peuhkuri, Helsinki University
Helsinki University
SalWe Ltd
Not Provided
Helsinki University
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP