Dairy Products and Metabolic Syndrome

NCT01913756 | Completed

• 1 other identifier: REK-340857
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure; Metabolic Syndrome X

Outcome Measures

Primary Outcomes (1)

• Change in blood pressure

  Baseline, 4 weeks and 8 weeks.

Secondary Outcomes (2)

• Change in serum cholesterol levels

  Baseline and 8 weeks.

• Change in body composition.

  Baseline and 8 weeks.

Study Arms (3)

Gouda-type cheese

EXPERIMENTAL

80 g/day Gouda-type cheese

Dietary Supplement: Gouda-type cheese

Low cheese intake

NO INTERVENTION

Gamalost (Norwegian traditional cheese)

EXPERIMENTAL

50 g/day Gamalost

Dietary Supplement: Gamalost (Norwegian traditional cheese)

Interventions

Gamalost (Norwegian traditional cheese) DIETARY_SUPPLEMENT

Gamalost (Norwegian traditional cheese)

Gouda-type cheese DIETARY_SUPPLEMENT

Gouda-type cheese

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Norwegian University of Life Sciences: lead
• Tine: collaborator

Study Sites (1)

Norwegian University of Life Sciences

Aas, Aas, 1432, Norway

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: July 30, 2013
• First Posted: August 1, 2013
• Study Start: April 1, 2013
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: November 18, 2014

Record last verified: 2014-11

Locations

NO (1)