NCT00941837

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Feb 2009

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

July 16, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 20, 2009

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

June 8, 2011

Status Verified

June 1, 2011

Enrollment Period

5 months

First QC Date

July 16, 2009

Last Update Submit

June 5, 2011

Conditions

Healthy

Keywords

Palm oleinhomocsyteineCholesterollipoproteinsInterleukinsCRPBlood PressureTotal homocysteinSerum lipid profileSerum apolipoproteinsInflammatory markers

Outcome Measures

Primary Outcomes (1)

  • Total homocysteine

    4th and 5th week

Secondary Outcomes (1)

  • Lipids profile and inflammatory markers

    4th and 5th weeks

Study Arms (3)

Olive Oil

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

Coconut oil

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

Palm Olein

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

Interventions

Olive Oil, Palm Olein Oil, Coconut OilDIETARY_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

Coconut oilOlive OilPalm Olein

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Malaysian Palm Oil Board

Kajang, Selangor, 43000, Malaysia

Location

Related Publications (2)

  • 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.

    PMID: 25804278DERIVED

  • 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.

    PMID: 22030224DERIVED

MeSH Terms

Interventions

Olive OilCoconut Oil

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFats, UnsaturatedPlant OilsOilsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Voon P T

    IMU/MPOB

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

July 16, 2009

First Posted

July 20, 2009

Study Start

February 1, 2009

Primary Completion

July 1, 2009

Study Completion

October 1, 2010

Last Updated

June 8, 2011

Record last verified: 2011-06

Locations

MY(1)