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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Olive Oil, Palm Olein Oil, Coconut Oil


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Olive Oil<br> | Dietary Supplement: Olive Oil, Palm Olein Oil, Coconut Oil<br>* Effect of dietary fat type in combination with high protein on plasma homocysteine levels; 5 wk each with 2 wk wash out in between<br>|
| Experimental: Coconut oil<br> | Dietary Supplement: Olive Oil, Palm Olein Oil, Coconut Oil<br>* Effect of dietary fat type in combination with high protein on plasma homocysteine levels; 5 wk each with 2 wk wash out in between<br>|
| Experimental: Palm Olein<br> | Dietary Supplement: Olive Oil, Palm Olein Oil, Coconut Oil<br>* Effect of dietary fat type in combination with high protein on plasma homocysteine levels; 5 wk each with 2 wk wash out in between<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total homocysteine |  | 4th and 5th week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipids profile and inflammatory markers |  | 4th and 5th weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Palm olein, homocsyteine, Cholesterol, lipoproteins, Interleukins, CRP, Blood Pressure, Total homocystein, Serum lipid profile, Serum apolipoproteins, Inflammatory markers