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Fat Quality on Blood Lipids and Immune Response (NoMa)

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ClinicalTrials.gov Identifier: NCT01679496
Recruitment Status : Completed
First Posted : September 6, 2012
Last Update Posted : February 4, 2015
Sponsor:
Collaborators:
University of Oslo
Mills DA
Information provided by (Responsible Party):
Stine Marie Ulven, Oslo and Akershus University College of Applied Sciences

Brief Summary:
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.

Condition or disease Intervention/treatment
Dietary Prevention Other: Food items

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Study Start Date : June 2012
Primary Completion Date : June 2014
Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Change in LDL-cholesterol [ Time Frame: Change from baseline after 8 weeks ]
    Change in LDL-cholesterol when compared to control diet

  2. Change in total cholesterol [ Time Frame: Change from baseline after 8 weeks ]
    Change in total cholesterol when compared to control diet


Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Appetite hormones [ Time Frame: Appetite hormones is measured at baseline and after 8 weeks of intervention ]
  4. Gut peptides [ Time Frame: Gut peptides are measured at baseline and after 8 weeks of intervention ]


Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01679496


Locations
Norway
Oslo and Akershus University College of Applied Sciences
Oslo, Norway, 0130
Sponsors and Collaborators
Oslo and Akershus University College of Applied Sciences
University of Oslo
Mills DA
Investigators
Principal Investigator: Stine Ulven, PhD Oslo and Akershus University College of Applied Sciences
Principal Investigator: Kirsten B Holven, PhD Department of Nutrition, Institute for Basic Medical Sciences, University of Oslo

Responsible Party: Stine Marie Ulven, Associate Professor, Oslo and Akershus University College of Applied Sciences
ClinicalTrials.gov Identifier: NCT01679496     History of Changes
Other Study ID Numbers: REK 2011/1951
First Posted: September 6, 2012    Key Record Dates
Last Update Posted: February 4, 2015
Last Verified: February 2015

Keywords provided by Stine Marie Ulven, Oslo and Akershus University College of Applied Sciences:
LDL-cholesterol