NCT01544270

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2012

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 5, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

April 25, 2013

Status Verified

April 1, 2013

Enrollment Period

6 months

First QC Date

February 16, 2012

Last Update Submit

April 24, 2013

Conditions

Chronic Stress

Keywords

milk proteinprobioticsstresscortisolheart beat

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Physiological measurements

    baseline and 4 weeks

Study Arms (3)

Study product containing milk proteins

ACTIVE COMPARATOR

Yoghurt-like milk-based product

Dietary Supplement: Yogurt-like snacks

Study product containing probiotics

ACTIVE COMPARATOR

Yoghurt-like milk-based product

Dietary Supplement: Yogurt-like snacks

Control product

PLACEBO COMPARATOR

Yoghurt-like milk-based product without supplemented nutrients

Dietary Supplement: Yogurt-like snacks

Interventions

Yogurt-like snacksDIETARY_SUPPLEMENT

twice a day 120 g for four weeks

Control productStudy product containing milk proteinsStudy product containing probiotics

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • STAI points 40-65
  • BMI 18-30 kg/m2
  • healthy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Helsinki, Institute of Biomedicine

Helsinki, 00014, Finland

Location

Related Publications (1)

  • 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.

    PMID: 24490888DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator, postdoctoral reseacher, authorized nutritionist

Study Record Dates

First Submitted

February 16, 2012

First Posted

March 5, 2012

Study Start

September 1, 2011

Primary Completion

March 1, 2012

Study Completion

September 1, 2012

Last Updated

April 25, 2013

Record last verified: 2013-04

Locations

FI(1)