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OpenTrials
Completed

NCT Number: NCT02194673

Acute Effects of Natural and Interesterified Fats-margarine on Lipemic and Insulinemic Response

Interesterified (IE) fat blends will respond differently in terms of postprandial lipemia and insulinemic responses compare to a trans free palm margarine (TFPM).

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Key information

Conditions

Healthy

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MalaysiaPOB

Kajang, Selangor, 43000, Malaysia

About this study

The objective of this study was to investigate whether IE-fat blends behave differently on postprandial serum lipid, insulin, C-peptide and glucose concentration compare to TFPM. A randomised, double-blind crossover (3 × 3 arms) orthogonal Latin-square design was used and conducted on 10 males and 10 females adults. During postprandial challenge day, each subject received an a test muffin incorporated with test margarine. Blood samples were collected at half-hourly intervals until 4 hr by using cannulation technique.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Body Mass Index (BMI) between 18.5 and 24.9
  • <130mmHg for systolic pressure and <80 mmHg for diastolic pressure
  • Blood glucose level in the range of 3.9 to 5.5 mmol/L
  • Total cholesterol less than 5.17 mmol/L
  • No use of tobacco and no consumption of alcohol.

Exclusion criteria

  • Suffer from chronic disease
  • Metabolic syndrome
  • Consuming any medical prescriptions
  • People with blood clotting problem
  • Women who are pregnant
  • Hypertensive person

Treatment and study plan

Trans free palm margarine

Other

A randomised, double-blind crossover (3 × 3 arms) orthogonal Latin-square design was used and conducted on 10 males and 10 females adults.

Interesterified Palm based margarine

Other

A randomised, double-blind crossover (3 × 3 arms) orthogonal Latin-square design was used and conducted on 10 males and 10 females adults.

IE Soybean oil-based margarine

Other

A randomised, double-blind crossover (3 × 3 arms) orthogonal Latin-square design was used and conducted on 10 males and 10 females adults.

Primary outcomes

  1. Change in serum triglycerides level of subjects as a measure of postprandial triglycerides response

    Time frame: Baseline, 4 hours

Secondary outcomes

  1. Change in the level of plasma insulin, c-peptide and serum glucose as a measure of postprandial insulinemic response

    Time frame: Baseline, 4 hours

Sponsors and collaborators

Lead sponsor

Malaysia Palm Oil Board

Other Gov

Collaborators

  • IMU University, Malaysia
  • Universiti Putra Malaysia

Registry information

Official study title

Acute Effects of Natural and Interesterified Fats-formulated Margarine on Lipemic and Insulinemic Response

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jul 18, 2014
Registry last updated
Jul 18, 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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