Fat Quality on Blood Lipids and Immune Response (NoMa)

August 16, 2021 updated by: Stine Marie Ulven, University of Oslo
The purpose of this study is to investigate blood LDL-cholesterol and level of inflammatory markers after intake of food items with different fatty acid composition.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

180

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

  • Norway
      • Oslo, Norway, 0316
        • University of Oslo

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

23 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • hsCRP < 10 mg/L
  • total cholesterol 5-7.8 mmol/l(50-70 y)
  • total cholesterol 5.0-6.9 mmol/l (30-49 y)
  • total cholesterol 5.0-6.1 mmol/l (25-29 y)
  • LDL-cholesterol at or above 3.5 mmol/l
  • triglycerides at or lower 2.6 mmol/l
  • BMI 20-35
  • Stable bodyweight last 3 months.

Exclusion Criteria:

  • Chronic diseases
  • fasting glucose > 6.0 mmol/l
  • increased ASAT and ALAT
  • medications affecting lipidmetabolism and inflammation

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
Experimental: Food items
Food items low in saturated fat and high in polyunsaturated fat
Other: Food items
Food items with different fatty acid composition
Placebo Comparator: Control food items
Food items containing saturated fat and polyunsaturated fat according to a traditional Norwegian diet
Other: Food items
Food items with different fatty acid composition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in LDL-cholesterol
Time Frame: Change from baseline after 8 weeks
Change in LDL-cholesterol when compared to control diet
Change from baseline after 8 weeks
Change in total cholesterol
Time Frame: Change from baseline after 8 weeks
Change in total cholesterol when compared to control diet
Change from baseline after 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inflammatory markers in circulation and at gene expression level in PBMC
Time Frame: Inflammatory markers are measured at baseline and after 8 weeks intervention in circulation and at gene expression level in PBMC
Inflammatory markers are measured at baseline and after 8 weeks intervention in circulation and at gene expression level in PBMC
Markers of lipid metabolism at gene expression level in PBMC
Time Frame: Markers of lipid metabolism at gene expression level in PBMC is measured at baseline and after 8 weeks of intervention
Markers of lipid metabolism at gene expression level in PBMC is measured at baseline and after 8 weeks of intervention
Appetite hormones
Time Frame: Appetite hormones is measured at baseline and after 8 weeks of intervention
Appetite hormones is measured at baseline and after 8 weeks of intervention
Gut peptides
Time Frame: Gut peptides are measured at baseline and after 8 weeks of intervention
Gut peptides are measured at baseline and after 8 weeks of intervention
Metabolites
Time Frame: Metabolites are measured at baseline and after 8 weeks of intervention
Targeted and untargeted metabolomics will be measured
Metabolites are measured at baseline and after 8 weeks of intervention
Whole genome gene expression
Time Frame: whole genome gene expression profiles are measured at baseline and after 8 weeks of intervention
Microarray
whole genome gene expression profiles are measured at baseline and after 8 weeks of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oslo

Collaborators

Oslo Metropolitan University
Mills DA

Investigators

  • Principal Investigator: Stine Ulven, PhD, University of Oslo
  • Principal Investigator: Kirsten B Holven, PhD, Department of Nutrition, Institute for Basic Medical Sciences, University of Oslo

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.

General Publications

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

June 1, 2012

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

August 24, 2012

First Submitted That Met QC Criteria

August 31, 2012

First Posted (Estimate)

September 6, 2012

Study Record Updates

Last Update Posted (Actual)

August 20, 2021

Last Update Submitted That Met QC Criteria

August 16, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • REK 2011/1951

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.

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