NCT00743301

Brief Summary

The aim of this study is to compare the effects of a diet rich in palm olein, a fraction of palm oil, to a diet rich in olive oil and a diet rich in Danish lard on plasma total-, LDL and HDL cholesterol as well as triacylglycerol (TAG), fasting insulin and glucose, C reactive protein and plasminogen activator inhibitor 1 in healthy men. The investigators hypothesis is that palm olein and olive oil will have the same effect on plasma total cholesterol, LDL- and HDL concentration and maybe also on the secondary outcome parameters that are related to cardiovascular disease risk. This may be caused by the differences in the sn-positioning of palmitic acid in palm olein. This difference may cause the palmitic acid in palm olein to be more prone to soap formations and excretion than palmitic acid from other sources, e.g. lard. This study is a double blinded, randomized, controlled 3 x 3 week crossover intervention study, without washout periods. The participants receive the three test foods in random order, decided by draw of lots. Blood samples are drawn in duplicate (on two following days) before and after each dietary period.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2008

Geographic Reach
1 country

1 active site

Status
unknown

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

August 1, 2008

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

August 27, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 28, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

August 28, 2008

Status Verified

August 1, 2008

Enrollment Period

6 months

First QC Date

August 27, 2008

Last Update Submit

August 27, 2008

Conditions

Cardiovascular DiseaseMetabolic Syndrome

Keywords

CVDPalm oleinOlive oilLardhealthy menmetabolic syndromeRisk of cardiovascular disease and metabolic syndrome

Outcome Measures

Primary Outcomes (1)

  • total, HDL, LDL cholesterol and triacylglycerol

    before and after each type of dietary fat

Secondary Outcomes (1)

  • fasting insulin and glucose, c reactive protein and plasminogen activator inhibitor 1

    befoer and after each dietary test fat

Study Arms (3)

Olive oil

ACTIVE COMPARATOR
Other: Palm olein vs olive oil and lard

Palm olein

EXPERIMENTAL
Other: Palm olein vs olive oil and lard

Lard

ACTIVE COMPARATOR
Other: Palm olein vs olive oil and lard

Interventions

Palm olein vs olive oil and lardOTHER

17E% from test fat is incorporated into three rolls and a piece of cake

LardOlive oilPalm olein

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All participants must give their informed consent in writing, after having received oral and written information about the study
  • Age: 18-65 y
  • BMI: 18.5 - 30 mg/m2
  • Men
  • Healthy (no known diseases, incl. hypertension, hypercholesterolemia, diabetes and psoriasis)
  • No use of dietary supplements or blood donations two month prior to and during the intervention

You may not qualify if:

  • Current or previously cardiovascular disease
  • Diabetes Mellitus or other severe chronic disease, including severe allergies and psoriasis
  • Hypertension
  • Known or suspected abuse of alcohol, drugs or medication
  • Own request: all participants have the right to withdraw from the intervention at any given time without explanation
  • Compliance: participants may be excluded from the intervention if they do not follow the study guidelines
  • Side effects (There are no side effects expected in this study since all test fats are commercial available and use in households world wide)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Human Nutrition

Frederiksberg, 1958, Denmark

RECRUITING

Related Publications (1)

  • Tholstrup T, Hjerpsted J, Raff M. Palm olein increases plasma cholesterol moderately compared with olive oil in healthy individuals. Am J Clin Nutr. 2011 Dec;94(6):1426-32. doi: 10.3945/ajcn.111.018846. Epub 2011 Nov 9.

    PMID: 22071711DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesMetabolic Syndrome

Interventions

lard

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Tine Tholstrup, PhD

    Department of Human Nutrition, University of Copenhagen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marianne Raff, PhD

CONTACT

+4535332533mrf@life.ku.dk

Tine Tholstrup, PhD

CONTACT

+4535332486tth@life.ku.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 27, 2008

First Posted

August 28, 2008

Study Start

August 1, 2008

Primary Completion

February 1, 2009

Study Completion

December 1, 2009

Last Updated

August 28, 2008

Record last verified: 2008-08

Locations

DK(1)