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OpenTrials
Completed

NCT Number: NCT01679496

Fat Quality on Blood Lipids and Immune Response

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.

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Key information

Conditions

Dietary Prevention

Age range

25 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Oslo

Oslo, 0316, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Food items

Other

Food items with different fatty acid composition

Primary outcomes

  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 outcomes

  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

  5. Metabolites

    Time frame: Metabolites are measured at baseline and after 8 weeks of intervention

    Targeted and untargeted metabolomics will be measured

  6. Whole genome gene expression

    Time frame: whole genome gene expression profiles are measured at baseline and after 8 weeks of intervention

    Microarray

Sponsors and collaborators

Lead sponsor

University of Oslo

Other

Collaborators

  • Mills DA
  • Oslo Metropolitan University

Registry information

Acronym: NoMa

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Sep 6, 2012
Registry last updated
Aug 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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