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Effect of Dietary Fat Type in Combination With High Protein on Plasma Homocysteine Levels

This study has been completed.
Sponsor:
Collaborator:
International Medical University (IMU), Kuala Lumpur,Malaysia
Information provided by:
Malaysia Palm Oil Board
ClinicalTrials.gov Identifier:
NCT00941837
First received: July 16, 2009
Last updated: June 5, 2011
Last verified: June 2011
History of Changes
  Purpose

In this study, the investigators address the research question of whether palm olein will have a positive influence on plasma total homocysteine levels in human volunteers provided with high-protein diets formulated from common Malaysian foods.

Hypothesis: There is a significant difference on the effects of the three experimental oils (palm olein, olive and coconut oil) on plasma tHy levels and the other markers of coronary heart disease (CHD) risk measured.


Condition Intervention
Healthy
 Dietary Supplement: Olive Oil, Palm Olein Oil, Coconut Oil

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Effect of Dietary Fat Type in Combination With High Protein on Plasma Homocysteine Levels and Selected Markers of Cardiovascular Heart Disease Risk in Human Volunteers

Resource links provided by NLM:

Drug Information available for: Olive oil
U.S. FDA Resources

Further study details as provided by Malaysia Palm Oil Board:

Primary Outcome Measures:
  • Total homocysteine [ Time Frame: 4th and 5th week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Lipids profile and inflammatory markers [ Time Frame: 4th and 5th weeks ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: February 2009
Study Completion Date: October 2010
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Olive Oil Dietary Supplement: Olive Oil, Palm Olein Oil, Coconut Oil
Effect of dietary fat type in combination with high protein on plasma homocysteine levels; 5 wk each with 2 wk wash out in between
Experimental: Coconut oil Dietary Supplement: Olive Oil, Palm Olein Oil, Coconut Oil
Effect of dietary fat type in combination with high protein on plasma homocysteine levels; 5 wk each with 2 wk wash out in between
Experimental: Palm Olein Dietary Supplement: Olive Oil, Palm Olein Oil, Coconut Oil
Effect of dietary fat type in combination with high protein on plasma homocysteine levels; 5 wk each with 2 wk wash out in between

Detailed Description:

The experimental are comprise of 30% kcal fat, 20% kcal protein and 50% kcal carbohydrate. Each of the test fat [palm olein (POo), virgin olive oil (OO) and coconut oil (CO)] contributes to two-thirds of total dietary fat will be compared.

Three meals a day providing 2000 kcal, including breakfast, lunch and dinner will be provided for the 5-weeks period of each fat rotation.

45 volunteers are fed with normal cooking oil for 3 weeks for standardisation purpose. They were then stratified into 3 groups according to gender, homocysteine and cholesterol level. The volunteers will be randomized, blinded and will undergo a 3 arms crossover intervention. Each intervention will take 5 wk with 2 wk wash out in between.

Baseline blood samples will be taken while other blood samples will be collected at week-4 and -5 of the study.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Apparently healthy adult males and females aged 20-60 years, with BMI 23.0 -29.9 kg/m2, and free from any disease (will be decided through history taking, physical examination and biochemical tests).
  • Not on any medication or treatment associated with reduction of CHD.
  • Non-smokers and non heavy drinker or having smoking or alcoholic history.
  • Not pregnant or lactating.
  • Willing to adhere to the Dietary Guidelines to the study.

Exclusion Criteria:

  • Obese [Body Mass Index (BMI) ≥ 30] or grossly underweight (BMI < 18).
  • Suffering from chronic diseases such as diabetes mellitus, CHD, cancer or any liver/renal disease.
  • People with blood clotting problem.
  • Hypertensive persons (systolic pressure > 140 mmHg, diastolic pressure > 90 mmHg)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00941837

Locations
Malaysia
Malaysian Palm Oil Board
Kajang, Selangor, Malaysia, 43000
Sponsors and Collaborators
Malaysia Palm Oil Board
International Medical University (IMU), Kuala Lumpur,Malaysia
Investigators
Principal Investigator: Voon P T IMU/MPOB
  More Information

No publications provided by Malaysia Palm Oil Board

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: MPOB
ClinicalTrials.gov Identifier: NCT00941837     History of Changes
Other Study ID Numbers: IMU R043/2008
Study First Received: July 16, 2009
Last Updated: June 5, 2011
Health Authority: Malaysia: Ministry of Health

Keywords provided by Malaysia Palm Oil Board:
Palm olein
homocsyteine
Cholesterol
lipoproteins
Interleukins
CRP
 Blood Pressure
Total homocystein
Serum lipid profile
Serum apolipoproteins
Inflammatory markers

ClinicalTrials.gov processed this record on May 19, 2013