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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01544270
First Posted: March 5, 2012
Last Update Posted: April 25, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
SalWe Ltd.
Information provided by (Responsible Party):
Katri Peuhkuri, Helsinki University
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 Katri Peuhkuri, Helsinki University:

Primary Outcome Measures:
  • Subjective well-being [ Time Frame: baseline and 4 weeks ]
    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 ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01544270


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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Submitted: February 16, 2012
First Posted: March 5, 2012
Last Update Posted: April 25, 2013
Last Verified: April 2013

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


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