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Dairy Products and Metabolic Syndrome

Primary Purpose

Blood Pressure, Metabolic Syndrome X

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Gamalost (Norwegian traditional cheese)
Gouda-type cheese
Sponsored by
Norwegian University of Life Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Blood Pressure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy adults
  • Must be able to eat cheese evey day

Exclusion Criteria:

  • Pregnant women
  • Taking blood pressure lowering medication
  • Not able to read Norwegian

Sites / Locations

  • Norwegian University of Life Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Experimental

Arm Label

Gouda-type cheese

Low cheese intake

Gamalost (Norwegian traditional cheese)

Arm Description

80 g/day Gouda-type cheese

50 g/day Gamalost

Outcomes

Primary Outcome Measures

Change in blood pressure

Secondary Outcome Measures

Change in serum cholesterol levels
Change in body composition.

Full Information

First Posted
July 30, 2013
Last Updated
November 17, 2014
Sponsor
Norwegian University of Life Sciences
Collaborators
Tine
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1. Study Identification

Unique Protocol Identification Number
NCT01913756
Brief Title
Dairy Products and Metabolic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Norwegian University of Life Sciences
Collaborators
Tine

4. Oversight

5. Study Description

Brief Summary
The purpose of this trial is to investigate the effect of dairy products on the so called metabolic syndrome. Metabolic syndrome is a cluster of risk factors, such as high blood pressure and high cholesterol, for the development of diabetes and heart disease. Participants will be randomly assigned to either eat a portion of a Norwegian traditional cheese which is high in protein and low in fat (group 1), or eat a slightly higher than normal intake of regular Gouda-type cheese (group 2), or to limit their intake of cheese (group 3). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Pressure, Metabolic Syndrome X

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
153 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gouda-type cheese
Arm Type
Experimental
Arm Description
80 g/day Gouda-type cheese
Arm Title
Low cheese intake
Arm Type
No Intervention
Arm Title
Gamalost (Norwegian traditional cheese)
Arm Type
Experimental
Arm Description
50 g/day Gamalost
Intervention Type
Dietary Supplement
Intervention Name(s)
Gamalost (Norwegian traditional cheese)
Intervention Type
Dietary Supplement
Intervention Name(s)
Gouda-type cheese
Primary Outcome Measure Information:
Title
Change in blood pressure
Time Frame
Baseline, 4 weeks and 8 weeks.
Secondary Outcome Measure Information:
Title
Change in serum cholesterol levels
Time Frame
Baseline and 8 weeks.
Title
Change in body composition.
Time Frame
Baseline and 8 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy adults Must be able to eat cheese evey day Exclusion Criteria: Pregnant women Taking blood pressure lowering medication Not able to read Norwegian
Facility Information:
Facility Name
Norwegian University of Life Sciences
City
Aas
ZIP/Postal Code
1432
Country
Norway

12. IPD Sharing Statement

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Dairy Products and Metabolic Syndrome

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