Study Results
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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COMPLETED
NA
153 participants
INTERVENTIONAL
2013-04-30
2013-07-31
Brief Summary
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Dairy products are a significant source of bioactive peptides, small pieces of protein which may have an effect on our health. These effects may be antimicrobial, antioxidative, or blood pressure lowering. The traditional Norwegian cheese, Gamalost, which is naturally high in protein (50%) and low in fat (\<1%), has been found to be particularly high in these bioactive peptides. Specifically, the cheese was found to have a very high ACE-inhibitory activity, meaning it has the potential to lower blood pressure without the use of pharmaceuticals.
A pilot study was performed in May 2012. No intervention was given in this trial, but participants answered an extensive questionnaire about dietary habits and lifestyle. This trial found that the people who ate the most Gamalost had a slightly lower blood pressure than those that did not eat the cheese. Since that was just a point-in-time study with no intervention or control, the investigators are not able to say anything certain about cause and effect, which is why the investigators want to perform this larger controlled study.
In total, the investigators aim to recruit 300 people to participate in this trial, i.e. 100 in each group. The participants will be randomly placed in one of the groups and they will have to do the intervention for eight weeks. At inclusion, the investigators measure blood pressure, fasting blood glucose, weight, height, waist circumference, and the investigators draw a fasting blood sample to measure cholesterol. The same measurements will be repeated at the end of the eight weeks. At inclusion they will also fill out an extensive questionnaire about their diet and lifestyle. A shorter version of the same questionnaire will also be given at the end of the trial period.
The overall goal of the study is to assess the effect of dairy products on the metabolic syndrome, but the main hypothesis is to assess whether a high intake of Gamalost can reduce blood pressure in a group of people.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Gouda-type cheese
80 g/day Gouda-type cheese
Gouda-type cheese
Low cheese intake
No interventions assigned to this group
Gamalost (Norwegian traditional cheese)
50 g/day Gamalost
Gamalost (Norwegian traditional cheese)
Interventions
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Gamalost (Norwegian traditional cheese)
Gouda-type cheese
Eligibility Criteria
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Inclusion Criteria
* Must be able to eat cheese evey day
Exclusion Criteria
* Taking blood pressure lowering medication
* Not able to read Norwegian
18 Years
ALL
Yes
Sponsors
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Tine
INDUSTRY
Norwegian University of Life Sciences
OTHER
Responsible Party
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Rita Nilsen
PhD Student
Locations
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Norwegian University of Life Sciences
Aas, Aas, Norway
Countries
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Other Identifiers
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REK-340857
Identifier Type: -
Identifier Source: org_study_id