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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02194673
• Other study ID #: AH 00112
• Status: Completed
• Phase: N/A
• First received: June 25, 2014
• Last updated: July 16, 2014
• Start date: January 2012
• Est. completion date: December 2012

Study information

• Verified date: July 2014
• Source: Malaysia Palm Oil Board
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malaysia: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Trans free palm margarine
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
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
A randomised, double-blind crossover (3 × 3 arms) orthogonal Latin-square design was used and conducted on 10 males and 10 females adults.

Locations

Country	Name	City	State
Malaysia	MalaysiaPOB	Kajang	Selangor

Sponsors (3)

Lead Sponsor	Collaborator
Malaysia Palm Oil Board	International Medical University, Universiti Putra Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in serum triglycerides level of subjects as a measure of postprandial triglycerides response		Baseline, 4 hours	No
Secondary	Change in the level of plasma insulin, c-peptide and serum glucose as a measure of postprandial insulinemic response		Baseline, 4 hours	No