AivoPro2: The Effects of Dietary Factors on Physiological Subjective Stress Responses

• Sponsor: University of Helsinki (Other)
• Overall Status: Completed
• CT.gov ID: NCT01544270
• Collaborator: SalWe Ltd. (Industry)
• Enrollment: 101
• Location: 1
• Arms: 3
• Duration (Months): 12
• Patients Per Site Per Month: 8.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Stress	Dietary Supplement: Yogurt-like snacks	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 101 participants
• 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
• Study Start Date: Sep 1, 2011
• Actual Primary Completion Date: Mar 1, 2012
• Actual Study Completion Date: Sep 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Subjective well-being [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

1. Physiological measurements [baseline and 4 weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	University of Helsinki, Institute of Biomedicine	Helsinki		Finland	00014

Sponsors and Collaborators

• University of Helsinki
• SalWe Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Katri Peuhkuri, Principal investigator, postdoctoral reseacher, authorized nutritionist, University of Helsinki
• ClinicalTrials.gov Identifier: NCT01544270
• Other Study ID Numbers: UH-SHOK-002
• First Posted: Mar 5, 2012
• Last Update Posted: Apr 25, 2013
• Last Verified: Apr 1, 2013

• Keywords provided by Katri Peuhkuri, Principal investigator, postdoctoral reseacher, authorized nutritionist, University of Helsinki: milk protein; probiotics; stress; cortisol; heart beat

Study Results

No Results Posted as of Apr 25, 2013