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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2010-10-31

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.

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Olive Oil

Group Type EXPERIMENTAL

Olive Oil, Palm Olein Oil, Coconut Oil

Intervention Type DIETARY_SUPPLEMENT

Effect of dietary fat type in combination with high protein on plasma homocysteine levels; 5 wk each with 2 wk wash out in between

Coconut oil

Group Type EXPERIMENTAL

Olive Oil, Palm Olein Oil, Coconut Oil

Intervention Type DIETARY_SUPPLEMENT

Effect of dietary fat type in combination with high protein on plasma homocysteine levels; 5 wk each with 2 wk wash out in between

Palm Olein

Group Type EXPERIMENTAL

Olive Oil, Palm Olein Oil, Coconut Oil

Intervention Type DIETARY_SUPPLEMENT

Effect of dietary fat type in combination with high protein on plasma homocysteine levels; 5 wk each with 2 wk wash out in between

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

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)

Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes