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Completed

NCT Number: NCT00715312

Effect of Oleic Acid on Inflammation Markers and Blood Lipid Metabolites: A Randomised, Double-Blind, Crossover Study

Rationale: The effect of positional distribution of dietary fatty acids on markers of inflammation and blood lipids metabolites on diets containing fatty acids such as oleic acid that are associated with reduced risk of cardiovascular disease is not widely studied.

Hypothesis: There would be difference detected in the concentrations of markers of inflammation and blood lipid metabolites in human volunteers fed controlled diets.

Study design: A randomized, double-blind, crossover clinical trial that involves 41 healthy volunteers. The volunteers will be selected based on inclusion and exclusion criteria. They will consume controlled diets for 5 weeks that provides 15% of energy from protein, 30% of energy from fat, and 55% of energy from carbohydrates. Volunteers will be assigned to each test diets which is cooked with novel olein, palm stearin or partially hydrogenated soybean oil in random order until all three diets has consumed by each person.

Main study parameters: LDL-cholesterol

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Malaysia Palm Oil Board

Kajang, Selangor, 50720, Malaysia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy and free from any disease and absence of family history for arteriosclerosis or hypertension
  • Not on any medication or supplements or weight loss program
  • Non smokers and alcoholics

Exclusion criteria

  • Having some health-related problems e.g fever, flu, allergy, chronic diseases
  • On some treatment or medication
  • Smokers and alcoholics

Treatment and study plan

Novel Olein

Other

A total of 70g of test oil is incorporated into cooked meal which accounts for 30-35% of calorie intake

Primary outcomes

  1. LDL-cholesterol

    Time frame: 5 weeks

Secondary outcomes

  1. C-reactive protein

    Time frame: 5 weeks

Sponsors and collaborators

Lead sponsor

Malaysia Palm Oil Board

Other Gov

Registry information

Official study title

Effect of Oleic Acid on Inflammation Markers and Blood Lipid Metabolites: A Randomised, Double-Blind, Crossover Study.

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jul 15, 2008
Registry last updated
Jul 15, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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