Fat Quality on Blood Lipids and Immune Response (NoMa)

This study is currently recruiting participants.
Verified June 2012 by Oslo and Akershus University College of Applied Sciences
Sponsor:
Collaborator:
University of Oslo
Information provided by (Responsible Party):
Oslo and Akershus University College of Applied Sciences
ClinicalTrials.gov Identifier:
NCT01679496
First received: August 24, 2012
Last updated: August 31, 2012
Last verified: June 2012
  Purpose

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 Intervention
Dietary Prevention
Other: Food items

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science

Resource links provided by NLM:


Further study details as provided by Oslo and Akershus University College of Applied Sciences:

Primary Outcome Measures:
  • Change in LDL-cholesterol [ Time Frame: Change from baseline after 8 weeks ] [ Designated as safety issue: No ]
    Change in LDL-cholesterol when compared to control diet

  • Change in total cholesterol [ Time Frame: Change from baseline after 8 weeks ] [ Designated as safety issue: No ]
    Change in total cholesterol when compared to control diet


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Appetite hormones [ Time Frame: Appetite hormones is measured at baseline and after 8 weeks of intervention ] [ Designated as safety issue: No ]
  • Gut peptides [ Time Frame: Gut peptides are measured at baseline and after 8 weeks of intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: June 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   25 Years to 70 Years
Genders Eligible for Study:   Both
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 20-31
  • Stable bodyweight last 3 months.

Exclusion Criteria:

  • Chronic diseases
  • fasting glucose > 6.0 mmol/l
  • increased ASAT and ALAT
  • medications affecting lipidmetabolism and inflammation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01679496

Locations
Norway
Oslo and Akershus University College of Applied Sciences Recruiting
Oslo, Norway, 0130
Contact: Stine Ulven, PhD       stinemarie.ulven@hioa.no   
Contact: Kirsten B Holven, PhD       kirsten.holven@medisin.uio.no   
Principal Investigator: Stine Ulven, PhD         
Sponsors and Collaborators
Oslo and Akershus University College of Applied Sciences
University of Oslo
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
  More Information

No publications provided

Responsible Party: Oslo and Akershus University College of Applied Sciences
ClinicalTrials.gov Identifier: NCT01679496     History of Changes
Other Study ID Numbers: REK 2011/1951
Study First Received: August 24, 2012
Last Updated: August 31, 2012
Health Authority: Norway: Regional Ethics Commitee

Keywords provided by Oslo and Akershus University College of Applied Sciences:
LDL-cholesterol

ClinicalTrials.gov processed this record on April 17, 2014