- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02924896
Effect of Palm Olein Intake on Lipid Profile and Appetite Regulation (APO)
The Chemical Structure of a Lipid Determines Its Effect on Blood Lipid Profile and Appetite Regulation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Design: A randomized, single blind, cross over design including 4 single study visits separated by a week. Visit 1 is an acclimatization visit followed by visit 2,3, and 4 where different types of fat will be given.
Population: 12 healthy males and females aged between 18 and 60 years with body mass index (BMI) between 18.5- 29.9kg/m2 and normal 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 hyperlipidaemia.
Treatment: Acclimatization visit: At visit 1, all participants will be given a milkshake like drink containing fat, protein and carbohydrate. A cannula will be inserted for the duration of the study day but no blood will be taken. Studies show than during the first visit stress response can affect the metabolic response to the study drink resulting in inaccurate results.
Study visit 2,3,4: following the acclimatization visit, participants will attend 3 more study visits separated by a week to test the metabolic response to the following fats: palm olein, interesterified palm olein and soybean oil in random order. Participants will be asked to complete a visual analogue scale questionnaire about their appetite at each time point. Fasting and postprandial plasma glucose, insulin, appetite hormones and lipids will be measured.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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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
Description
Inclusion Criteria:
- Healthy and overweight male and female volunteers of all ethnicities (body mass index (BMI) of 18.5-29.9 kg/m2)
- Age between 18-60 years (inclusive)
Exclusion Criteria:
- 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
- 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
- Subjects with history of hypo- and hyperthyroidism
- Subjects who are anaemic and those who donated blood within three months of the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Arm 1
Palm Olein
|
60g of palm olein will be given in a milkshake at breakfast
60g of interesterified palm olein will be given in a milkshake at breakfast
60g of soybean oil will be given in a milkshake at breakfast
|
|
Other: Arm 2
Soybean Oil
|
60g of palm olein will be given in a milkshake at breakfast
60g of interesterified palm olein will be given in a milkshake at breakfast
60g of soybean oil will be given in a milkshake at breakfast
|
|
Other: Arm 3
Interesterified Palm Olein
|
60g of palm olein will be given in a milkshake at breakfast
60g of interesterified palm olein will be given in a milkshake at breakfast
60g of soybean oil will be given in a milkshake at breakfast
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change From Baseline in Appetite Hormones PYY
Time Frame: 480 minutes
|
blood samples will be collected at specific time points presented as minutes from consumption of mixed meal. time (minutes)=-15, -5, 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 420, 480. |
480 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change From Baseline in Glucose,
Time Frame: 480 min
|
blood samples will be collected at specific time points presented as minutes from consumption of mixed meal.
time (minutes)=-15, -5, 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 420, 480
|
480 min
|
|
Change From Baseline in Appetite Hormones GLP_1
Time Frame: ime (minutes)=-15, -5, 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 420, 480. Time Frame: 480 minutes
|
Change From Baseline in Appetite Hormones Hide Description: blood samples will be collected at specific time points presented as minutes from consumption of mixed meal. time (minutes)=-15, -5, 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 420, 480. |
ime (minutes)=-15, -5, 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 420, 480. Time Frame: 480 minutes
|
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
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16/WA/0117
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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