Acute Effects of Natural and Interesterified Fats-margarine on Lipemic and Insulinemic Response
1 other identifier
interventional
20
1 country
1
Brief Summary
Interesterified (IE) fat blends will respond differently in terms of postprandial lipemia and insulinemic responses compare to a trans free palm margarine (TFPM).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable healthy
Started Jan 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 25, 2014
CompletedFirst Posted
Study publicly available on registry
July 18, 2014
CompletedJuly 18, 2014
July 1, 2014
11 months
June 25, 2014
July 16, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Change in serum triglycerides level of subjects as a measure of postprandial triglycerides response
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
Baseline, 4 hours
Study Arms (3)
Trans free palm margarine
EXPERIMENTALOne high fat muffin will be serves together with a glass of low fat milk shake.
Interesterified palm based margarine
EXPERIMENTALOne high fat muffin will be serves together with a glass of low fat milk shake.
IE soybean oil-based margarine
EXPERIMENTALOne high fat muffin will be serves together with a glass of low fat milk shake.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Suffer from chronic disease
- Metabolic syndrome
- Consuming any medical prescriptions
- People with blood clotting problem
- Women who are pregnant
- Hypertensive person
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Malaysia Palm Oil Boardlead
- IMU University, Malaysiacollaborator
- Universiti Putra Malaysiacollaborator
Study Sites (1)
MalaysiaPOB
Kajang, Selangor, 43000, Malaysia
Study Officials
- PRINCIPAL INVESTIGATOR
Voon Phooi Tee, Ph.D
Malaysia Palm Oil Board
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 25, 2014
First Posted
July 18, 2014
Study Start
January 1, 2012
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
July 18, 2014
Record last verified: 2014-07