Skip to main content
OpenTrials
Completed

NCT Number: NCT00941837

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Malaysian Palm Oil Board

Kajang, Selangor, 43000, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Olive Oil, Palm Olein Oil, Coconut Oil

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

Primary outcomes

  1. Total homocysteine

    Time frame: 4th and 5th week

Secondary outcomes

  1. Lipids profile and inflammatory markers

    Time frame: 4th and 5th weeks

Sponsors and collaborators

Lead sponsor

Malaysia Palm Oil Board

Other Gov

Collaborators

  • International Medical University (IMU), Kuala Lumpur,Malaysia

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Jul 20, 2009
Registry last updated
Jun 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.