- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02245113
Effects of High Oleic Palm Olein, Virgin Olive Oil and Coconut Oil Diets on Markers Selected in Malaysian
September 18, 2014 updated by: Malaysia Palm Oil Board
Effects of High Oleic Palm Olein (HOPO), Virgin Olive Oil (OO) and Refined Bleached and Deodorized (RBD) Coconut Oil (CO) Diets on Lipid Profile, Markers of Insulin Resistance, Inflammatory and Obesity in Overweight Subject.
This study will be comparing human body responses by the effects of diets cooked with NoveLin, virgin olive oil and RBD coconut oil.
Study Overview
Detailed Description
NoveLin has high content of monounsaturate fatty acids - oleic acid (C18:1) which is the predominant fatty acid and in this study NoveLin is used as cooking fat in compare with olive oil.
Olive oil is the world's most commonly eaten monounsaturated oil which contains 55 - 83% oleic acid.
Consumption of olive oil gives numerous health benefits on lowering total and LDL cholesterol, reducing LDL cholesterol's, lowering blood clotting factors, and lowering blood pressure.
Coconut oil is the richest source of medium chain fatty acid and it has greater than 90% of saturated fatty acid with dominant fatty acid of lauric acid (C12:0).
RBD coconut oil is used as positive control in this study.
Study Type
Interventional
Enrollment (Actual)
32
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
- MPOB
-
-
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 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- males and females aged 20-60 years
- BMI 23 - 27.5 kg/m2
- free from any disease
- not on any medication or treatment associated with reduction of CVD
- non-smokers and non-heavy drinker or having smoking or alcoholic history
- not pregnant or lactating
- willing and able to comply
Exclusion Criteria:
- people on weight reduction therapy/program
- people on cholesterol reduction medicatio
- have one or more of the chronic diseases
- people with blood clotting problem/ coagulopathy / deep vein thrombosis.
- hypertensive persons (systolic pressure > 140 mmHg, diastolic pressure > 90 mmHg)
- female who is pregnant
- people travel to overseas during feeding.
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Test Fat P
Test fat, n= 10 (minimum), 6 weeks intervention, Intervention 1, Intervention 2, and Intervention 3.
|
Feeding trial for 6 weeks (week 0 - baseline).
The experimental diets are comprised of 30% kcal fat, 15% kcal protein and 55% kcal carbohydrate.
Each of the test fat contributes to two-thirds of total dietary fat will be compared.
|
Experimental: Test Fat Q
Test fat, n= 10 (minimum), 6 weeks intervention, Intervention 1, Intervention 2, and Intervention 3.
|
Feeding trial for 6 weeks (week 0 - baseline).
The experimental diets are comprised of 30% kcal fat, 15% kcal protein and 55% kcal carbohydrate.
Each of the test fat contributes to two-thirds of total dietary fat will be compared.
|
Experimental: Test Fat R
Test fat, n= 10 (minimum), 6 weeks intervention, Intervention 1, Intervention 2, and Intervention 3.
|
Feeding trial for 6 weeks (week 0 - baseline).
The experimental diets are comprised of 30% kcal fat, 15% kcal protein and 55% kcal carbohydrate.
Each of the test fat contributes to two-thirds of total dietary fat will be compared.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
change in c-peptide level
Time Frame: week 0(baseline) and week 6
|
week 0(baseline) and week 6
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
change in insulin resistance's markers
Time Frame: week 0(baseline) and week 6
|
week 0(baseline) and week 6
|
change in inflammatory markers
Time Frame: week 0(baseline) and week 6
|
week 0(baseline) and week 6
|
change in obesity markers
Time Frame: week 0(baseline) and week 6
|
week 0(baseline) and week 6
|
change in lipid profile
Time Frame: week 0(baseline) and week 6
|
week 0(baseline) and week 6
|
change in physical characteristic (eg. BMI, body weight)
Time Frame: week 0(baseline) and week 6
|
week 0(baseline) and week 6
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lee Sin Tien, BSc, UPM
- Principal Investigator: Norhaizan Md Esa, PhD, UPM
- Principal Investigator: Verna Lee Kar Mun, PhD, IMU
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
December 1, 2013
Primary Completion (Actual)
June 1, 2014
Study Completion (Actual)
July 1, 2014
Study Registration Dates
First Submitted
September 17, 2014
First Submitted That Met QC Criteria
September 18, 2014
First Posted (Estimate)
September 19, 2014
Study Record Updates
Last Update Posted (Estimate)
September 19, 2014
Last Update Submitted That Met QC Criteria
September 18, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R002302000
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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