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

April 24, 2013 updated by: Katri Peuhkuri, University of Helsinki

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

101

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland, 00014
        • University of Helsinki, Institute of Biomedicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline and 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physiological measurements
Time Frame: baseline and 4 weeks
Change in salivary cortisol, blood pressure, heart beat variability, sleep and inflammatory markers.
baseline and 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Helsinki

Collaborators

SalWe Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

February 16, 2012

First Submitted That Met QC Criteria

February 28, 2012

First Posted (Estimate)

March 5, 2012

Study Record Updates

Last Update Posted (Estimate)

April 25, 2013

Last Update Submitted That Met QC Criteria

April 24, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UH-SHOK-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Stress

Clinical Trials on Yogurt-like snacks

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Serbia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe