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

This study has been completed.
Sponsor:
Collaborator:
University of Malaya
Information provided by:
Malaysia Palm Oil Board
ClinicalTrials.gov Identifier:
NCT01124487
First received: May 12, 2010
Last updated: May 14, 2010
Last verified: May 2010
History of Changes
  Purpose

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.


Condition Intervention
Lipid Profile
 Dietary Supplement: The acute effects of dietary fat on lipid profile, insulin sensitivity and inflammatory markers

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: The Acute Effects of Oleic Acid Enriched-diets on Lipids, Insulin Sensitivity and Serum Inflammatory Markers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Malaysia Palm Oil Board:

Primary Outcome Measures:
  • Triacylglycerol (TAG) [ Time Frame: 4 h ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Insulin sensitivity (glucose, insulin), non-esterified fatty acids (NEFA), inflammatory markers [ Time Frame: 4 h ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: August 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: palm olein Dietary Supplement: The acute effects of dietary fat on lipid profile, insulin sensitivity and inflammatory markers
Experimental: olive oil Dietary Supplement: The acute effects of dietary fat on lipid profile, insulin sensitivity and inflammatory markers
Experimental: lard Dietary Supplement: The acute effects of dietary fat on lipid profile, insulin sensitivity and inflammatory markers

Detailed 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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01124487

Locations
Malaysia
Malaysian Palm Oil Board
Kajang, Selangor, Malaysia, 43000
Sponsors and Collaborators
Malaysia Palm Oil Board
University of Malaya
Investigators
Principal Investigator: Teng Kim Tiu, Msc Malaysia Palm Oil Board and University of Malaya
  More Information

No publications provided

Responsible Party: Dr. Kalanithi Nesaretnam, Malaysia Palm Oil Board
ClinicalTrials.gov Identifier: NCT01124487     History of Changes
Other Study ID Numbers: A001/09
Study First Received: May 12, 2010
Last Updated: May 14, 2010
Health Authority: Malaysia: Ministry of Health

Keywords provided by Malaysia Palm Oil Board:
fat
inflammation
lipids
 total cholesterol
Triglycerides
insulin sensitivity

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
 Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013