The Acute Effects of Oleic Acid Enriched-diets on Lipids, Insulin Sensitivity and Serum Inflammatory Markers

Lipid Profile Clinical Trial

Official title:

The Acute Effects of Oleic Acid Enriched-diets on Lipids, Insulin Sensitivity and Serum Inflammatory Markers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01124487
• Other study ID #: A001/09
• Status: Completed
• Phase: N/A
• First received: May 12, 2010
• Last updated: May 14, 2010
• Start date: August 2009
• Est. completion date: September 2009

Study information

• Verified date: May 2010
• Source: Malaysia Palm Oil Board
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malaysia: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Description:

A randomized, single blind, crossover design was undertaken to test meals enriched with palm olein vs olive oil vs lard. Volunteers were asked to participate in three postprandial challenges, separated by at least 3-days. Subjects were provided a low fat meal(<10g fat) the day before the intervention. Fasting blood was collected the next day and the subjects were instructed to consume test meals (50g high fat meal). Further venous blood was collected at 30 min, 1h, 2h, 3h and 4h postprandially.

Primary outcome variable: Triacylglycerol (TAG) Secondary outcome variables: Insulin sensitivity (glucose, insulin), non esterified fatty acids (NEFA), inflammatory markers

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Age: 18-45 years

• BMI : 18.5-30 kg/m^2

• Healthy, men

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Insulin Resistance
• Lipid Profile

Intervention

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

Locations

Country	Name	City	State
Malaysia	Malaysian Palm Oil Board	Kajang	Selangor

Sponsors (2)

Lead Sponsor	Collaborator
Malaysia Palm Oil Board	University of Malaya

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Triacylglycerol (TAG)		4 h	No
Secondary	Insulin sensitivity (glucose, insulin), non-esterified fatty acids (NEFA), inflammatory markers		4 h	No