Chronic StressAivoPro2NCT01544270
The Effects of Dietary Factors on Physiological Subjective Stress Responses
A study testing Yogurt-like snacks in people with Chronic Stress, run by University of Helsinki at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Stress
- What is being tested?
- Yogurt-like snacks
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 101 participants
- Where
- 1 siteFinland
- Study dates
- Sep 2011to Sep 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- STAI points 40-65
- BMI 18-30 kg/m2
- healthy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Finland1 site
University of Helsinki, Institute of Biomedicine
Helsinki, 00014
About this study
Official title: 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.
- Conditions
- Chronic Stress
- Being tested
- Yogurt-like snacks
- Keywords
- milk protein, probiotics, stress, cortisol, heart beat
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yogurt-like snacksDietary supplement
twice a day 120 g for four weeks
| Study group | Role | What they receive |
|---|---|---|
| Study product containing milk proteins | Active comparator | Yoghurt-like milk-based product Receives: Dietary Supplement: Yogurt-like snacks |
| Study product containing probiotics | Active comparator | Yoghurt-like milk-based product Receives: Dietary Supplement: Yogurt-like snacks |
| Control product | Placebo comparator | Yoghurt-like milk-based product without supplemented nutrients Receives: Dietary Supplement: Yogurt-like snacks |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline and 4 weeks
Secondary outcomes (1)
Physiological measurements
Change in salivary cortisol, blood pressure, heart beat variability, sleep and inflammatory markers.
Measured: baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2012 (estimated)
- Study startSep 2011
- Primary completionMar 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Collaborators
- SalWe Ltd.
- Responsible party
- Principal investigator, Katri Peuhkuri, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01544270
- Sponsor's protocol ID
- UH-SHOK-002
- Acronym
- AivoPro2
- Status last verified
- Apr 2013
- First submitted
- 16 Feb 2012
- Last updated
- 25 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24490888
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Dietary Factors on Physiological Subjective Stress Responses in Cronically Stressed Subjects: a Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT01544270
- Acronym / sponsor ID
- AivoPro2 / UH-SHOK-002
- Conditions
- Chronic Stress
- Keywords
- milk protein, probiotics, stress, cortisol, heart beat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Collaborators
- SalWe Ltd.
- Study start
- Sep 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 5 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Study product containing milk proteins | Active comparator | Dietary Supplement: Yogurt-like snacksYoghurt-like milk-based product |
| Study product containing probiotics | Active comparator | Dietary Supplement: Yogurt-like snacksYoghurt-like milk-based product |
| Control product | Placebo comparator | Dietary Supplement: Yogurt-like snacksYoghurt-like milk-based product without supplemented nutrients |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- STAI points 40-65
- BMI 18-30 kg/m2
- healthy
Key exclusion criteria (7 listed)
- Gastrointestinal disease, diabetes or any other significant major medical morbidity
- milk allergy
- smoking
- excess use of alcohol
- pregnancy and breast feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yogurt-like snackstwice a day 120 g for four weeks | Dietary supplement | Control product, Study product containing milk proteins, Study product containing probiotics |
Primary outcome
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
1 secondary outcome
Physiological measurements
Time frame: baseline and 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2013.
- Derived from this study: PubMed 24490888Jaatinen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yogurt-like snacks in people with Chronic Stress, run by University of Helsinki at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective well-being (time frame: baseline and 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01544270, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2013.