- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02194673
Acute Effects of Natural and Interesterified Fats-margarine on Lipemic and Insulinemic Response
July 16, 2014 updated by: Malaysia Palm Oil Board
Acute Effects of Natural and Interesterified Fats-formulated 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).
Study Overview
Status
Completed
Conditions
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Selangor
-
Kajang, Selangor, Malaysia, 43000
- MalaysiaPOB
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Trans free palm margarine
One high fat muffin will be serves together with a glass of low fat milk shake.
|
A randomised, double-blind crossover (3 × 3 arms) orthogonal Latin-square design was used and conducted on 10 males and 10 females adults.
A randomised, double-blind crossover (3 × 3 arms) orthogonal Latin-square design was used and conducted on 10 males and 10 females adults.
A randomised, double-blind crossover (3 × 3 arms) orthogonal Latin-square design was used and conducted on 10 males and 10 females adults.
|
|
Experimental: Interesterified palm based margarine
One high fat muffin will be serves together with a glass of low fat milk shake.
|
A randomised, double-blind crossover (3 × 3 arms) orthogonal Latin-square design was used and conducted on 10 males and 10 females adults.
A randomised, double-blind crossover (3 × 3 arms) orthogonal Latin-square design was used and conducted on 10 males and 10 females adults.
A randomised, double-blind crossover (3 × 3 arms) orthogonal Latin-square design was used and conducted on 10 males and 10 females adults.
|
|
Experimental: IE soybean oil-based margarine
One high fat muffin will be serves together with a glass of low fat milk shake.
|
A randomised, double-blind crossover (3 × 3 arms) orthogonal Latin-square design was used and conducted on 10 males and 10 females adults.
A randomised, double-blind crossover (3 × 3 arms) orthogonal Latin-square design was used and conducted on 10 males and 10 females adults.
A randomised, double-blind crossover (3 × 3 arms) orthogonal Latin-square design was used and conducted on 10 males and 10 females adults.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in serum triglycerides level of subjects as a measure of postprandial triglycerides response
Time Frame: Baseline, 4 hours
|
Baseline, 4 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in the level of plasma insulin, c-peptide and serum glucose as a measure of postprandial insulinemic response
Time Frame: Baseline, 4 hours
|
Baseline, 4 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Voon Phooi Tee, Ph.D, Malaysia Palm Oil Board
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
June 25, 2014
First Submitted That Met QC Criteria
July 16, 2014
First Posted (Estimate)
July 18, 2014
Study Record Updates
Last Update Posted (Estimate)
July 18, 2014
Last Update Submitted That Met QC Criteria
July 16, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- AH 00112
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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