The Effects of Dietary Factors on Physiological Subjective Stress Responses

NCT ID: NCT01544270

Last Updated: 2013-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Study product containing milk proteins

Yoghurt-like milk-based product

Group Type ACTIVE_COMPARATOR

Yogurt-like snacks

Intervention Type DIETARY_SUPPLEMENT

twice a day 120 g for four weeks

Study product containing probiotics

Yoghurt-like milk-based product

Group Type ACTIVE_COMPARATOR

Yogurt-like snacks

Intervention Type DIETARY_SUPPLEMENT

twice a day 120 g for four weeks

Control product

Yoghurt-like milk-based product without supplemented nutrients

Group Type PLACEBO_COMPARATOR

Yogurt-like snacks

Intervention Type DIETARY_SUPPLEMENT

twice a day 120 g for four weeks

Interventions

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Yogurt-like snacks

twice a day 120 g for four weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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SalWe Ltd.

INDUSTRY

Sponsor Role collaborator

University of Helsinki

OTHER

Sponsor Role lead

Responsible Party

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Katri Peuhkuri

Principal investigator, postdoctoral reseacher, authorized nutritionist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Helsinki, Institute of Biomedicine

Helsinki, , Finland

Site Status

Countries

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Finland

References

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Jaatinen N, Korpela R, Poussa T, Turpeinen A, Mustonen S, Merilahti J, Peuhkuri K. Effects of daily intake of yoghurt enriched with bioactive components on chronic stress responses: a double-blinded randomized controlled trial. Int J Food Sci Nutr. 2014 Jun;65(4):507-14. doi: 10.3109/09637486.2014.880669. Epub 2014 Feb 4.

Reference Type DERIVED
PMID: 24490888 (View on PubMed)

Other Identifiers

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UH-SHOK-002

Identifier Type: -

Identifier Source: org_study_id

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