NCT02194673

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

June 25, 2014

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 18, 2014

Completed
Last Updated

July 18, 2014

Status Verified

July 1, 2014

Enrollment Period

11 months

First QC Date

June 25, 2014

Last Update Submit

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

EXPERIMENTAL

One high fat muffin will be serves together with a glass of low fat milk shake.

Other: Trans free palm margarineOther: Interesterified Palm based margarineOther: IE Soybean oil-based margarine

Interesterified palm based margarine

EXPERIMENTAL

One high fat muffin will be serves together with a glass of low fat milk shake.

Other: Trans free palm margarineOther: Interesterified Palm based margarineOther: IE Soybean oil-based margarine

IE soybean oil-based margarine

EXPERIMENTAL

One high fat muffin will be serves together with a glass of low fat milk shake.

Other: Trans free palm margarineOther: Interesterified Palm based margarineOther: IE Soybean oil-based margarine

Interventions

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 margarineInteresterified palm based margarineTrans 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.

IE soybean oil-based margarineInteresterified palm based margarineTrans 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.

IE soybean oil-based margarineInteresterified palm based margarineTrans free palm margarine

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Study Sites (1)

MalaysiaPOB

Kajang, Selangor, 43000, Malaysia

Location

Study Officials

  • Voon Phooi Tee, Ph.D

    Malaysia Palm Oil Board

    PRINCIPAL INVESTIGATOR

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

Locations