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Chronic Effects of Natural and Interesterified Fats Margarine on Insulin Sensitivity and Selected Markers of Cardiovascular Diseases (CVD)

Chronic Effects of Natural Palm-based Margarine and Interesterified Palm- and Soy-based Margarine on Insulin Sensitivity and Selected Markers of Cardiovascular Diseases (CVD)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02192047
Enrollment
85
Registered
2014-07-16
Start date
2012-09-30
Completion date
2014-03-31
Last updated
2014-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight

Brief summary

The investigators hypothesized that there will be a significant difference between the effects of trans-free palm-, interesterified palm- and interesterified soybean oil blend on cardiovascular disease, inflammation, insulin resistance and obesity.

Detailed description

Human volunteers will be conditioned for a 8 wk intervention on 3 different test diets providing 30 % energy as fat, 15% energy as protein and 55% energy as carbohydrate according to parallel designed sequences. The test fats used for this study are palm oil, chemically interesterified palm oil and chemically interesterified fully hydrogenated soybean oil and soft oil blend in the form of margarine. Volunteers will be restricted to follow the dietary guidelines throughout the study. Blood collection sessions will held before and after every diet intervention. Outcome measures of the study are serum lipid profile, markers of inflammation, markers of obesity and insulin resistance.

Interventions

8 weeks

OTHERIE Palm olein

8 weeks

OTHERIE soybean oil-based

8 weeks

Sponsors

IMU University, Malaysia
CollaboratorOTHER
Universiti Putra Malaysia
CollaboratorOTHER
Malaysia Palm Oil Board
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* Adult males and females, aged 20-60 yr * Staff and students of International Medical University, IMU/ Staff of Malaysian Palm Oil Board, MPOB to facilitate centralized consumption of the test fats/snacks * BMI 21 - 30 kg/m2

Exclusion criteria

* Abnomal liver function test (elevated transaminases- alanine aminotransferase,ALT; aspartate aminotransferase,AST))/ abnormal kidney function test (elevated plasma creatinine) * History of type 2 diabetes mellitus, cancer, stomach ulcers, drug abuse or alcoholism * Smokers * On lipid/blood pressure- lowering medication/supplements * Blood pressure\>140/90 mmHg * Fasting total cholesterol \> 6.5 mmol/L * Fasting TAG \> 2.0 mmol/L * Candidates who are going abroad during the planned schedule for the dietary intervention

Design outcomes

Primary

MeasureTime frame
Change in serum C-peptide level of subjectup to 8 weeks

Secondary

MeasureTime frame
Change in serum lipid profileup to 8 weeks
Change in markers of inflammationup to 8 weeks
Change in markers of obesityup to 8 weeks
Change in markers of insulin resistanceup to 8 weeks
Oral Glucose tolerance test (OGTT)Baseline, month-2

Countries

Malaysia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026