- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01544270
The Effects of Dietary Factors on Physiological Subjective Stress Responses (AivoPro2)
April 24, 2013 updated by: Katri Peuhkuri, University of Helsinki
The Effects of Dietary Factors on Physiological Subjective Stress Responses in Cronically Stressed Subjects: a Randomised Clinical Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
101
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Helsinki, Finland, 00014
- University of Helsinki, Institute of Biomedicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Study product containing milk proteins
Yoghurt-like milk-based product
|
twice a day 120 g for four weeks
|
Active Comparator: Study product containing probiotics
Yoghurt-like milk-based product
|
twice a day 120 g for four weeks
|
Placebo Comparator: Control product
Yoghurt-like milk-based product without supplemented nutrients
|
twice a day 120 g for four weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
baseline and 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physiological measurements
Time Frame: baseline and 4 weeks
|
Change in salivary cortisol, blood pressure, heart beat variability, sleep and inflammatory markers.
|
baseline and 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2011
Primary Completion (Actual)
March 1, 2012
Study Completion (Actual)
September 1, 2012
Study Registration Dates
First Submitted
February 16, 2012
First Submitted That Met QC Criteria
February 28, 2012
First Posted (Estimate)
March 5, 2012
Study Record Updates
Last Update Posted (Estimate)
April 25, 2013
Last Update Submitted That Met QC Criteria
April 24, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- UH-SHOK-002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Stress
-
Joseph Pergolizzi, MDLeraPharm Inc.TerminatedChronic StressUnited States
-
University of Texas at AustinNot yet recruitingPTSD | Anhedonia | Post Traumatic Stress Disorder | Chronic Post-Traumatic Stress Disorder | Diminished Pleasure | Chronic PTSDUnited States
-
Boston Children's HospitalNational Center for Complementary and Integrative Health (NCCIH)RecruitingStress, Psychological | Chronic Widespread Pain | Stress, PhysiologicalUnited States
-
VA Office of Research and DevelopmentCompletedChronic Low Back Pain | Chronic Neck Pain | Post-Traumatic Stress DisorderUnited States
-
LI ChengNot yet recruitingRisk-Taking | Chronic Stress
-
RIVER FoundationRecruitingChronic Pain | Anxiety Disorders | Chronic Disease | Post Traumatic Stress Disorder | Major Depressive Disorder | Chronic ConditionUnited States
-
University of North Carolina, Chapel HillNational Institute on Aging (NIA)CompletedEarly Life Adversity | Chronic StressUnited States
-
University of California, Los AngelesDefense Advanced Research Projects Agency; Defense Group, Inc.CompletedPost-traumatic Stress Disorder | Post-Traumatic Stress Disorder, ChronicUnited States
-
National Council of Scientific and Technical Research...CompletedChronic Stress DisorderArgentina
-
Northern California Institute of Research and EducationCompletedChronic Posttraumatic Stress Disorder
Clinical Trials on Yogurt-like snacks
-
University of NisNot yet recruitingDiabetes Mellitus, Type 2 | Overweight or Obesity
-
Virginia Polytechnic Institute and State UniversityCompleted
-
University of IcelandCompleted
-
Rush University Medical CenterCompleted
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR); McMaster University; Canadian...Completed
-
University of Alabama at BirminghamNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedObesity | Glucose IntoleranceUnited States
-
Jose María Maya MejíaUnknown
-
Instituto de Investigación Hospital Universitario...Go Fruselva, S.L.Completed
-
Colorado State UniversityNational Cancer Institute (NCI); Poudre Valley Health SystemCompletedColorectal Cancer Control and PreventionUnited States
-
BioibericaTechnological Centre of Nutrition and HealthCompletedLow Intensity Knee GonalgiaSpain