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Fat Quality on Blood Lipids and Immune Response

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01679496
Acronym
NoMa
Enrollment
180
Registered
2012-09-06
Start date
2012-06-30
Completion date
2014-06-30
Last updated
2021-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dietary Prevention

Keywords

LDL-cholesterol

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.

Interventions

OTHERFood items

Food items with different fatty acid composition

Sponsors

Oslo Metropolitan University
CollaboratorOTHER
Mills DA
CollaboratorINDUSTRY
University of Oslo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
25 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in LDL-cholesterolChange from baseline after 8 weeksChange in LDL-cholesterol when compared to control diet
Change in total cholesterolChange from baseline after 8 weeksChange in total cholesterol when compared to control diet

Secondary

MeasureTime frameDescription
Appetite hormonesAppetite hormones is measured at baseline and after 8 weeks of intervention
Gut peptidesGut peptides are measured at baseline and after 8 weeks of intervention
Inflammatory markers in circulation and at gene expression level in PBMCInflammatory markers are measured at baseline and after 8 weeks intervention in circulation and at gene expression level in PBMC
Whole genome gene expressionwhole genome gene expression profiles are measured at baseline and after 8 weeks of interventionMicroarray
MetabolitesMetabolites are measured at baseline and after 8 weeks of interventionTargeted and untargeted metabolomics will be measured
Markers of lipid metabolism at gene expression level in PBMCMarkers of lipid metabolism at gene expression level in PBMC is measured at baseline and after 8 weeks of intervention

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026