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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Olive Oil, Palm Olein Oil, Coconut Oil

• Registration Number: NCT00941837
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2009-02
• Primary Completion: 2009-07
• Study First Submitted: 2009-07-16
• Study First Submitted QC: 2009-07-17
• Study First Posted: 2009-07-20
• Study Completion: 2010-10
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-05
• Last Update Posted: 2011-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Olive Oil	Olive Oil, Palm Olein Oil, Coconut Oil	-
Coconut oil	Olive Oil, Palm Olein Oil, Coconut Oil	-
Palm Olein	Olive Oil, Palm Olein Oil, Coconut Oil	-

Primary Outcome Measures

Name	Time	Method
Total homocysteine	4th and 5th week

Secondary Outcome Measures

Name	Time	Method
Lipids profile and inflammatory markers	4th and 5th weeks

Trial Locations

Locations (1)

Malaysian Palm Oil Board; 🇲🇾 Kajang, Selangor, Malaysia