NCT01124487

Brief Summary

Objectives: To investigate the acute effects of olive oil, palm olein and lard on lipid profile, insulin sensitivity and inflammatory markers. Hypothesis: Different dietary fats will alter lipid profile, insulin sensitivity and inflammatory markers postprandially.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2009

Shorter than P25 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

August 1, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 17, 2010

Completed
Last Updated

May 17, 2010

Status Verified

May 1, 2010

Enrollment Period

1 month

First QC Date

May 12, 2010

Last Update Submit

May 14, 2010

Conditions

Lipid Profile

Keywords

fatinflammationlipidstotal cholesterolTriglyceridesinsulin sensitivity

Outcome Measures

Primary Outcomes (1)

  • Triacylglycerol (TAG)

    4 h

Secondary Outcomes (1)

  • Insulin sensitivity (glucose, insulin), non-esterified fatty acids (NEFA), inflammatory markers

    4 h

Study Arms (3)

palm olein

EXPERIMENTAL
Dietary Supplement: The acute effects of dietary fat on lipid profile, insulin sensitivity and inflammatory markers

olive oil

EXPERIMENTAL
Dietary Supplement: The acute effects of dietary fat on lipid profile, insulin sensitivity and inflammatory markers

lard

EXPERIMENTAL
Dietary Supplement: The acute effects of dietary fat on lipid profile, insulin sensitivity and inflammatory markers

Interventions

The acute effects of dietary fat on lipid profile, insulin sensitivity and inflammatory markersDIETARY_SUPPLEMENT
lardolive oilpalm olein

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age: 18-45 years
  • BMI : 18.5-30 kg/m\^2
  • Healthy, men

You may not qualify if:

  • medical history of cardiovascular disease, cancer, diabetes or chronic diseases
  • BMI \< 18.5 OR \> 30 kg/m\^2
  • waist hip ratio \> 0.9
  • total cholesterol \> 5.2 mmol/L
  • triacylglycerol (TAG) \> 2.2 mmol/L
  • current use of antihypertensive or lipid lowering medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Malaysian Palm Oil Board

Kajang, Selangor, 43000, Malaysia

Location

MeSH Terms

Conditions

Platelet Glycoprotein IV DeficiencyInflammationInsulin Resistance

Interventions

Insulin

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Teng Kim Tiu, Msc

    Malaysia Palm Oil Board and University of Malaya

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

May 12, 2010

First Posted

May 17, 2010

Study Start

August 1, 2009

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

May 17, 2010

Record last verified: 2010-05

Locations

MY(1)