ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00941837
Recruitment Status : Completed
First Posted : July 20, 2009
Last Update Posted : June 8, 2011
Sponsor:
Collaborator:
International Medical University (IMU), Kuala Lumpur,Malaysia
Information provided by:
Malaysia Palm Oil Board

Brief Summary:

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 or disease Intervention/treatment Phase
Healthy Dietary Supplement: Olive Oil, Palm Olein Oil, Coconut Oil Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
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
Study Start Date : February 2009
Actual Primary Completion Date : July 2009
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fats
Drug Information available for: Olive oil

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Total homocysteine [ Time Frame: 4th and 5th week ]

Secondary Outcome Measures :
  1. Lipids profile and inflammatory markers [ Time Frame: 4th and 5th weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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