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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 November 20, 2014