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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00941837
Enrollment
45
Registered
2009-07-20
Start date
2009-02-28
Completion date
2010-10-31
Last updated
2011-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

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

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.

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

Sponsors

International Medical University (IMU), Kuala Lumpur,Malaysia
CollaboratorUNKNOWN
Malaysia Palm Oil Board
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
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

* 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)

Design outcomes

Primary

MeasureTime frame
Total homocysteine4th and 5th week

Secondary

MeasureTime frame
Lipids profile and inflammatory markers4th and 5th weeks

Countries

Malaysia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026