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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00941837
• Other study ID #: IMU R043/2008
• Status: Completed
• Phase: N/A
• First received: July 16, 2009
• Last updated: June 5, 2011
• Start date: February 2009
• Est. completion date: October 2010

Study information

• Verified date: June 2011
• Source: Malaysia Palm Oil Board
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malaysia: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: October 2010
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
Malaysia	Malaysian Palm Oil Board	Kajang	Selangor

Sponsors (2)

Lead Sponsor	Collaborator
Malaysia Palm Oil Board	International Medical University (IMU), Kuala Lumpur,Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total homocysteine		4th and 5th week	No
Secondary	Lipids profile and inflammatory markers		4th and 5th weeks	No