Clinical trial NCT01679496: Fat Quality on Blood Lipids and Immune Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Prevention
Keywords: LDL-cholesterol
Lead sponsor: University of Oslo
Sponsor class: OTHER
Collaborators: name: Oslo Metropolitan University
name: Mills DA
First posted: 2012-09-06
Enrollment: 180
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: Change in LDL-cholesterol
timeFrame: Change from baseline after 8 weeks
measure: Change in total cholesterol
timeFrame: Change from baseline after 8 weeks
Secondary outcomes:
measure: Inflammatory markers in circulation and at gene expression level in PBMC
timeFrame: Inflammatory markers are measured at baseline and after 8 weeks intervention in circulation and at gene expression level in PBMC
measure: Markers of lipid metabolism at gene expression level in PBMC
timeFrame: Markers of lipid metabolism at gene expression level in PBMC is measured at baseline and after 8 weeks of intervention
measure: Appetite hormones
timeFrame: Appetite hormones is measured at baseline and after 8 weeks of intervention
measure: Gut peptides
timeFrame: Gut peptides are measured at baseline and after 8 weeks of intervention
measure: Metabolites
timeFrame: Metabolites are measured at baseline and after 8 weeks of intervention
measure: Whole genome gene expression
timeFrame: whole genome gene expression profiles are measured at baseline and after 8 weeks of intervention
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: University of Oslo
Study officials:
affiliation: University of Oslo
name: Stine Ulven, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Nutrition, Institute for Basic Medical Sciences, University of Oslo
name: Kirsten B Holven, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pigsborg K, Gurdeniz G, Rangel-Huerta OD, Holven KB, Dragsted LO, Ulven SM. Effects of changing from a diet with saturated fat to a diet with n-6 polyunsaturated fat on the serum metabolome in relation to cardiovascular disease risk factors. Eur J Nutr. 2022 Jun;61(4):2079-2089. doi: 10.1007/s00394-021-02796-6. Epub 2022 Jan 9.
citation: Ulven SM, Christensen JJ, Nygard O, Svardal A, Leder L, Ottestad I, Lysne V, Laupsa-Borge J, Ueland PM, Midttun O, Meyer K, McCann A, Andersen LF, Holven KB. Using metabolic profiling and gene expression analyses to explore molecular effects of replacing saturated fat with polyunsaturated fat-a randomized controlled dietary intervention study. Am J Clin Nutr. 2019 May 1;109(5):1239-1250. doi: 10.1093/ajcn/nqy356.