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CompletedNCT00941837Updated Jun 8, 2011

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

An interventional study of Olive Oil, Palm Olein Oil, Coconut Oil in Healthy, sponsored by Malaysia Palm Oil Board. Completed at 1 site in Malaysia. Open to participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-06-08.

Sponsored by Malaysia Palm Oil Board · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Healthy

Keywords

  • Palm olein
  • homocsyteine
  • Cholesterol
  • lipoproteins
  • Interleukins
  • CRP
  • Blood Pressure
  • Total homocystein
  • Serum lipid profile
  • Serum apolipoproteins
  • Inflammatory markers
03

In context

Lead sponsor

Malaysia Palm Oil Board is the lead sponsor of 24 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
45 participants (actual)

Study arms

  • Experimental
    Olive Oil

    Dietary Supplement: Olive Oil, Palm Olein Oil, Coconut Oil

  • Experimental
    Coconut oil

    Dietary Supplement: Olive Oil, Palm Olein Oil, Coconut Oil

  • Experimental
    Palm Olein

    Dietary Supplement: Olive Oil, Palm Olein Oil, Coconut Oil

Interventions

  • Dietary supplementOlive 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

06

What researchers measure

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

07

Study locations

1 site
  • Malaysian Palm Oil Board
    Kajang, Selangor 43000, Malaysia
08

References and documents

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. PubMed 25804278 ↗
  • 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. PubMed 22030224 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 8, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00941837
Lead sponsor
Malaysia Palm Oil Board
Collaborators
International Medical University (IMU), Kuala Lumpur,Malaysia
First posted
Jul 20, 2009
Start date
Feb 2009
Primary completion
Jul 2009
Completion
Oct 2010
Last update
Jun 8, 2011

Study contacts

Voon P T
principal investigator · IMU/MPOB

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.

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