Fat Quality on Blood Lipids and Immune Response

Dietary Prevention Clinical Trial

— NoMa  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01679496
• Other study ID #: REK 2011/1951
• Status: Completed
• Phase: N/A
• Start date: June 2012
• Est. completion date: June 2014

Study information

• Verified date: August 2021
• Source: University of Oslo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Dietary Prevention

Intervention

Other:
• Food items
Food items with different fatty acid composition

Locations

Country	Name	City	State
Norway	University of Oslo	Oslo

Sponsors (3)

Lead Sponsor	Collaborator
University of Oslo	Mills DA, Oslo Metropolitan University

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in LDL-cholesterol	Change in LDL-cholesterol when compared to control diet	Change from baseline after 8 weeks
Primary	Change in total cholesterol	Change in total cholesterol when compared to control diet	Change from baseline after 8 weeks
Secondary	Inflammatory markers 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
Secondary	Markers of lipid metabolism at gene expression level in PBMC		Markers of lipid metabolism at gene expression level in PBMC is measured at baseline and after 8 weeks of intervention
Secondary	Appetite hormones		Appetite hormones is measured at baseline and after 8 weeks of intervention
Secondary	Gut peptides		Gut peptides are measured at baseline and after 8 weeks of intervention
Secondary	Metabolites	Targeted and untargeted metabolomics will be measured	Metabolites are measured at baseline and after 8 weeks of intervention
Secondary	Whole genome gene expression	Microarray	whole genome gene expression profiles are measured at baseline and after 8 weeks of intervention