Clinical trial NCT00941837: Effect of Dietary Fat Type in Combination With High Protein on Plasma Homocysteine Levels
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Palm olein
homocsyteine
Cholesterol
lipoproteins
Interleukins
CRP
Blood Pressure
Total homocystein
Serum lipid profile
Serum apolipoproteins
Inflammatory markers
Lead sponsor: Malaysia Palm Oil Board
Sponsor class: OTHER_GOV
Collaborators: name: International Medical University (IMU), Kuala Lumpur,Malaysia
First posted: 2009-07-20
Enrollment: 45
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Total homocysteine
timeFrame: 4th and 5th week
Secondary outcomes:
measure: Lipids profile and inflammatory markers
timeFrame: 4th and 5th weeks
Other outcomes:
Locations:
city: Kajang
country: Malaysia
facility: Malaysian Palm Oil Board
state: Selangor
Study officials:
affiliation: IMU/MPOB
name: Voon P T
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.