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OpenTrials
Completed

NCT Number: NCT02192047

Chronic Effects of Natural and Interesterified Fats Margarine on Insulin Sensitivity and Selected Markers of Cardiovascular Diseases (CVD)

The investigators hypothesized that there will be a significant difference between the effects of trans-free palm-, interesterified palm- and interesterified soybean oil blend on cardiovascular disease, inflammation, insulin resistance and obesity.

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Key information

Conditions

Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Putra Malaysia

Serdang, Selangor, 43400, Malaysia

About this study

Human volunteers will be conditioned for a 8 wk intervention on 3 different test diets providing 30 % energy as fat, 15% energy as protein and 55% energy as carbohydrate according to parallel designed sequences. The test fats used for this study are palm oil, chemically interesterified palm oil and chemically interesterified fully hydrogenated soybean oil and soft oil blend in the form of margarine. Volunteers will be restricted to follow the dietary guidelines throughout the study. Blood collection sessions will held before and after every diet intervention. Outcome measures of the study are serum lipid profile, markers of inflammation, markers of obesity and insulin resistance.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult males and females, aged 20-60 yr
  • Staff and students of International Medical University, IMU/ Staff of Malaysian Palm Oil Board, MPOB to facilitate centralized consumption of the test fats/snacks
  • BMI 21 - 30 kg/m2

Exclusion criteria

  • Abnomal liver function test (elevated transaminases- alanine aminotransferase,ALT; aspartate aminotransferase,AST))/ abnormal kidney function test (elevated plasma creatinine)
  • History of type 2 diabetes mellitus, cancer, stomach ulcers, drug abuse or alcoholism
  • Smokers
  • On lipid/blood pressure- lowering medication/supplements
  • Blood pressure>140/90 mmHg
  • Fasting total cholesterol > 6.5 mmol/L
  • Fasting TAG > 2.0 mmol/L
  • Candidates who are going abroad during the planned schedule for the dietary intervention

Treatment and study plan

Palm olein

Other

8 weeks

IE Palm olein

Other

8 weeks

IE soybean oil-based

Other

8 weeks

Primary outcomes

  1. Change in serum C-peptide level of subject

    Time frame: up to 8 weeks

Secondary outcomes

  1. Change in serum lipid profile

    Time frame: up to 8 weeks

  2. Change in markers of inflammation

    Time frame: up to 8 weeks

  3. Change in markers of obesity

    Time frame: up to 8 weeks

  4. Change in markers of insulin resistance

    Time frame: up to 8 weeks

  5. Oral Glucose tolerance test (OGTT)

    Time frame: Baseline, month-2

Sponsors and collaborators

Lead sponsor

Malaysia Palm Oil Board

Other Gov

Collaborators

  • IMU University, Malaysia
  • Universiti Putra Malaysia

Registry information

Official study title

Chronic Effects of Natural Palm-based Margarine and Interesterified Palm- and Soy-based Margarine on Insulin Sensitivity and Selected Markers of Cardiovascular Diseases (CVD)

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jul 16, 2014
Registry last updated
Jul 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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