Effect of Dietary Fat Type in Combination With High Protein on Plasma Homocysteine Levels
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Selangor
-
Kajang, Selangor, Malaysia, 43000
- Malaysian Palm Oil Board
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Olive 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
|
|
EXPERIMENTAL: 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
|
|
EXPERIMENTAL: Palm Olein
|
Effect of dietary fat type in combination with high protein on plasma homocysteine levels; 5 wk each with 2 wk wash out in between
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Total homocysteine
Time Frame: 4th and 5th week
|
4th and 5th week
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Lipids profile and inflammatory markers
Time Frame: 4th and 5th weeks
|
4th and 5th weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Voon P T, IMU/MPOB
Publications and helpful links
General Publications
- Voon PT, Ng TK, Lee VK, Nesaretnam K. Virgin olive oil, palm olein and coconut oil diets do not raise cell adhesion molecules and thrombogenicity indices in healthy Malaysian adults. Eur J Clin Nutr. 2015 Jun;69(6):712-6. doi: 10.1038/ejcn.2015.26. Epub 2015 Mar 25.
- Voon PT, Ng TK, Lee VK, Nesaretnam K. Diets high in palmitic acid (16:0), lauric and myristic acids (12:0 + 14:0), or oleic acid (18:1) do not alter postprandial or fasting plasma homocysteine and inflammatory markers in healthy Malaysian adults. Am J Clin Nutr. 2011 Dec;94(6):1451-7. doi: 10.3945/ajcn.111.020107. Epub 2011 Oct 26. Erratum In: Am J Clin Nutr. 2012 Mar;95(3):780.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IMU R043/2008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.