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
  Purpose

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.


Condition Intervention
Chronic Stress
Dietary Supplement: Yogurt-like snacks

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effects of Dietary Factors on Physiological Subjective Stress Responses in Cronically Stressed Subjects: a Randomised Clinical Trial

Further study details as provided by Helsinki University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Enrollment: 101
Study Start Date: September 2011
Study Completion Date: September 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Study product containing milk proteins
Yoghurt-like milk-based product
Dietary Supplement: Yogurt-like snacks
twice a day 120 g for four weeks
Active Comparator: Study product containing probiotics
Yoghurt-like milk-based product
Dietary Supplement: Yogurt-like snacks
twice a day 120 g for four weeks
Placebo Comparator: Control product
Yoghurt-like milk-based product without supplemented nutrients
Dietary Supplement: Yogurt-like snacks
twice a day 120 g for four weeks

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01544270

Locations
Finland
University of Helsinki, Institute of Biomedicine
Helsinki, Finland, 00014
Sponsors and Collaborators
Helsinki University
SalWe Ltd
  More Information

Additional Information:
No publications provided

Responsible Party: Katri Peuhkuri, Principal investigator, postdoctoral reseacher, authorized nutritionist, Helsinki University
ClinicalTrials.gov Identifier: NCT01544270     History of Changes
Other Study ID Numbers: UH-SHOK-002
Study First Received: February 16, 2012
Last Updated: April 24, 2013
Health Authority: Finland: Ethics Committee

Keywords provided by Helsinki University:
milk protein
probiotics
stress
cortisol
heart beat

ClinicalTrials.gov processed this record on April 17, 2014