NCT01679496

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 6, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

August 20, 2021

Status Verified

August 1, 2021

Enrollment Period

2 years

First QC Date

August 24, 2012

Last Update Submit

August 16, 2021

Conditions

Dietary Prevention

Keywords

LDL-cholesterol

Outcome Measures

Primary Outcomes (2)

  • Change in LDL-cholesterol

    Change in LDL-cholesterol when compared to control diet

    Change from baseline after 8 weeks

  • Change in total cholesterol

    Change in total cholesterol when compared to control diet

    Change from baseline after 8 weeks

Secondary Outcomes (6)

  • 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

  • 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

  • Appetite hormones

    Appetite hormones is measured at baseline and after 8 weeks of intervention

  • Gut peptides

    Gut peptides are measured at baseline and after 8 weeks of intervention

  • Metabolites

    Metabolites are measured at baseline and after 8 weeks of intervention

  • +1 more secondary outcomes

Study Arms (2)

Food items

EXPERIMENTAL

Food items low in saturated fat and high in polyunsaturated fat

Other: Food items

Control food items

PLACEBO COMPARATOR

Food items containing saturated fat and polyunsaturated fat according to a traditional Norwegian diet

Other: Food items

Interventions

Food itemsOTHER

Food items with different fatty acid composition

Control food itemsFood items

Eligibility Criteria

Age25 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Chronic diseases
  • fasting glucose \> 6.0 mmol/l
  • increased ASAT and ALAT
  • medications affecting lipidmetabolism and inflammation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oslo

Oslo, 0316, Norway

Location

Related Publications (2)

  • 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.

    PMID: 34999928DERIVED

  • 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.

    PMID: 31051508DERIVED

Study Officials

  • Stine Ulven, PhD

    University of Oslo

    PRINCIPAL INVESTIGATOR

  • Kirsten B Holven, PhD

    Department of Nutrition, Institute for Basic Medical Sciences, University of Oslo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 24, 2012

First Posted

September 6, 2012

Study Start

June 1, 2012

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

August 20, 2021

Record last verified: 2021-08

Locations

NO(1)