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OpenTrials
Completed

NCT Number: NCT01544270

The Effects of Dietary Factors on Physiological Subjective Stress Responses

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.

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Key information

Conditions

Chronic Stress

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Helsinki, Institute of Biomedicine

Helsinki, 00014, Finland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Yogurt-like snacks

Dietary Supplement

twice a day 120 g for four weeks

Primary outcomes

  1. 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 outcomes

  1. Physiological measurements

    Time frame: baseline and 4 weeks

    Change in salivary cortisol, blood pressure, heart beat variability, sleep and inflammatory markers.

Sponsors and collaborators

Lead sponsor

University of Helsinki

Other

Collaborators

  • SalWe Ltd.

Registry information

Official study title

The Effects of Dietary Factors on Physiological Subjective Stress Responses in Cronically Stressed Subjects: a Randomised Clinical Trial

Acronym: AivoPro2

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 5, 2012
Registry last updated
Apr 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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