- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02897674
Effect of Palm Olein Intake on Lipid Profile and Fat Deposition (PalmOil)
The Chemical Structure of a Lipid Determines Its Effect on Blood Lipid Profile and Fat Deposition
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Design: Randomized, parallel design over 14 weeks including a 2 week standardization period and 12 week supplementation. In the standardization period all participants will incorporate palm oil into their diet which will make up 20% of their calories providing a baseline measure. In the supplementation period of 12 weeks, each volunteer will be randomized into one of the three fats: palm olein, interesterified palm olein or soybean oil, consuming 20% of their calories from these fast and remaining 10% fat calories from fats naturally occurring in foods like meat and nuts. Otherwise participants will keep the rest of their diet habitual.
Population: 60 healthy males and females aged between 18 and 60 years, of which 30 participants with a BMI between 18.5-24.9kg/m2 and 30 participants with a BMI between 25-29.9kg/m2 and fasting plasma glucose and no evidence of insulin resistance will be recruited. No pre-existing morbidity including cardiac, hepatic or renal disease, history of diabetes, hypertension or hyperlipidemia.
Treatment: Pre-intervention: Participants will be asked to record habitual dietary intake by completion of a 4-day food diary and be asked to wear an accelerometer armband to assess physical activity at the beginning and at the end of supplementation period.
2 weeks standardization period: All participants will be asked to replace added fat in their diet with palm olein providing two thirds of 30% fat calories.
At the end of the standardization period, which will be the first day of a 12 week dietary intervention, as well as at the end of 12 week supplementation, participants will attend the clinical research facility for a study visit. Weight, height and waist circumference will be taken; total and regional body composition will be measured by MRI. Fasting and post prandial plasma glucose, insulin, appetite hormones and lipids will be measured. Participants will be asked to come in for follow-up visits at week 6 and 10 for a single blood samples and weight check.
12 week supplementation period: participants will be randomized into one of the three supplementation groups: palm olein, interesterified palm olein or soybean oil. Participants will be asked to consume two thirds of their 30%fat calories from one of the oils while incorporating it into their normal diet in cooking and baking.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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London, United Kingdom, W12 0HS
- NIHR/Wellcome Trust Imperial Clinical Research Facility
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Phase I: 30 healthy volunteers (male and female), of all ethnicities, aged 18-60 years, with a body mass index (BMI) of 18.5-25kg/m2.
- Phase II: 30 healthy volunteers (male and female), of all ethnicities, aged 18-60 years, with a BMI of 25-29.9kg/m2.
Exclusion Criteria:
- Following a high fat diet (more than 40% calories coming from fat)
- Abnormal liver function test (elevated alanine aminotransferase and aspartate transaminase)/ abnormal kidney function test (elevated plasma creatinine)
- History of type 2 diabetes mellitus, cancer, stomach ulcers, drug abuse or alcoholism, gastrointestinal disorders like Crohn's disease
- Smokers
- On lipid/blood pressure- lowering medication/supplements
- Blood pressure>140/90 mm Hg
- Fasting total cholesterol > 6.2 mmol/L
- Fasting triacylglyceride > 2.0 mmol/L
- Candidates who are going abroad during the planned schedule for the dietary intervention
- Subject must not be allergic to intervention
- Pregnancy and breastfeeding (pregnancy test will be undertaken at the screening visit)
- Subjects taking nutritional supplements or on any weight-loss programs
- Subjects who gained or lost ≥ 3kg weight in the past three months
- Female subjects were not on oral contraceptives.
- Subjects with history of hypo- and hyperthyroidism
- Claustrophobia
- Metal implants for example cardiac pacemakers and join replacement
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Normal weight
Participants will BMI 18.5-24.9
kg/m2 will consume 20% of their calories from one of the three dietary fats Intervention: palm olei Intervention: interesterified palm olein Intervention: soybean oil
|
two thirds of the 30% fat calories will come from palm olein
two thirds of the 30% fat calories will come from interesterified palm olein
two thirds of the 30% fat calories will come from soybean oil
|
Experimental: Overweight
Participants will BMI 25-29.9
kg/m2 will consume 20% of their calories from one of the three dietary fats Intervention: palm olei Intervention: interesterified palm olein Intervention: soybean oil
|
two thirds of the 30% fat calories will come from palm olein
two thirds of the 30% fat calories will come from interesterified palm olein
two thirds of the 30% fat calories will come from soybean oil
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in total cholesterol following the supplementation
Time Frame: fasting measure in week 3, 6, 10, 14
|
fasting measure in week 3, 6, 10, 14
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in body composition
Time Frame: Fasting measure in week 3 and week 14
|
total and regional body composition assessed by MRI
|
Fasting measure in week 3 and week 14
|
Change from baseline in lipoproteins
Time Frame: time=0 in week 3, 6, 10, 14
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time=0 in week 3, 6, 10, 14
|
|
Postprandial change in appetite hormones
Time Frame: time=-15, -5,15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 420, 480 in week 3 and week 14
|
time=-15, -5,15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 420, 480 in week 3 and week 14
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Gary Frost, Imperial College London
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 15HH2616
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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