The Effects of Dietary Factors on Physiological Subjective Stress Responses

Chronic Stress Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01544270
• Other study ID #: UH-SHOK-002
• Status: Completed
• Phase: N/A
• First received: February 16, 2012
• Last updated: April 24, 2013
• Start date: September 2011
• Est. completion date: September 2012

Study information

• Verified date: April 2013
• Source: Helsinki University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: September 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Chronic Stress

Intervention

Dietary Supplement:
• Yogurt-like snacks
twice a day 120 g for four weeks

Locations

Country	Name	City	State
Finland	University of Helsinki, Institute of Biomedicine	Helsinki

Sponsors (2)

Lead Sponsor	Collaborator
Helsinki University	SalWe Ltd.

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective well-being	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	No
Secondary	Physiological measurements	Change in salivary cortisol, blood pressure, heart beat variability, sleep and inflammatory markers.	baseline and 4 weeks	No

External Links

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