Fat Quality on Blood Lipids and Immune Response (NoMa)

This study has been completed.
Sponsor:
Collaborators:
University of Oslo
Mills DA
Information provided by (Responsible Party):
Stine Marie Ulven, Oslo and Akershus University College of Applied Sciences
ClinicalTrials.gov Identifier:
NCT01679496
First received: August 24, 2012
Last updated: February 3, 2015
Last verified: February 2015
  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 ]

Enrollment: 180
Study Start Date: June 2012
Study Completion Date: June 2014
Primary Completion Date: June 2014 (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 20-35
  • Stable bodyweight last 3 months.

Exclusion Criteria:

  • Chronic diseases
  • fasting glucose > 6.0 mmol/l
  • increased ASAT and ALAT
  • medications affecting lipidmetabolism and inflammation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: August 24, 2012
Last Updated: February 3, 2015
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 July 30, 2015