Effect of Palm Olein Intake on Lipid Profile and Appetite Regulation (APO)
Primary Purpose
Lipidaemia
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Palm olein
Interesterified palm olein
Soybean oil
Sponsored by
About this trial
This is an interventional basic science trial for Lipidaemia
Eligibility Criteria
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
Sites / Locations
- NIHR/Wellcome Trust Imperial Clinical Research Facility
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Other
Other
Other
Other
Other
Other
Arm Label
randomization 1
randomization 2
randomization 3
randomization 4
randomization 5
randomization 6
Arm Description
Palm Olein, Interesterified Palm Olein, Soybean Oil
Palm Olein, Soybean Oil, Interesterified Palm Olein
Interesterified Palm Olein, Palm Olein, Soybean Oil
Interesterified Palm Olein, Soybean Oil, Palm Olein
Soybean Oil, Interesterified Palm Olein, Palm Olein
Soybean Oil, Palm Olein, Interesterified Palm Olein
Outcomes
Primary Outcome Measures
change from baseline in appetite hormones
blood samples will be collected at specific time points presented as minutes from consumption of mixed meal
Secondary Outcome Measures
change from baseline in lipids
blood samples will be collected at specific time points presented as minutes from consumption of mixed meal
Full Information
NCT ID
NCT02924896
First Posted
September 28, 2016
Last Updated
March 8, 2018
Sponsor
Imperial College London
Collaborators
Malaysia Palm Oil Board
1. Study Identification
Unique Protocol Identification Number
NCT02924896
Brief Title
Effect of Palm Olein Intake on Lipid Profile and Appetite Regulation
Acronym
APO
Official Title
The Chemical Structure of a Lipid Determines Its Effect on Blood Lipid Profile and Appetite Regulation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London
Collaborators
Malaysia Palm Oil Board
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Aims: To investigate whether acute ingestions of palm oil will have an effect on appetite regulation
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lipidaemia
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
randomization 1
Arm Type
Other
Arm Description
Palm Olein, Interesterified Palm Olein, Soybean Oil
Arm Title
randomization 2
Arm Type
Other
Arm Description
Palm Olein, Soybean Oil, Interesterified Palm Olein
Arm Title
randomization 3
Arm Type
Other
Arm Description
Interesterified Palm Olein, Palm Olein, Soybean Oil
Arm Title
randomization 4
Arm Type
Other
Arm Description
Interesterified Palm Olein, Soybean Oil, Palm Olein
Arm Title
randomization 5
Arm Type
Other
Arm Description
Soybean Oil, Interesterified Palm Olein, Palm Olein
Arm Title
randomization 6
Arm Type
Other
Arm Description
Soybean Oil, Palm Olein, Interesterified Palm Olein
Intervention Type
Dietary Supplement
Intervention Name(s)
Palm olein
Intervention Description
60g of palm olein will be given in a milkshake at breakfast
Intervention Type
Dietary Supplement
Intervention Name(s)
Interesterified palm olein
Intervention Description
60g of interesterified palm olein will be given in a milkshake at breakfast
Intervention Type
Dietary Supplement
Intervention Name(s)
Soybean oil
Intervention Description
60g of soybean oil will be given in a milkshake at breakfast
Primary Outcome Measure Information:
Title
change from baseline in appetite hormones
Description
blood samples will be collected at specific time points presented as minutes from consumption of mixed meal
Time Frame
time (minutes)=-15, -5, 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 420, 480
Secondary Outcome Measure Information:
Title
change from baseline in lipids
Description
blood samples will be collected at specific time points presented as minutes from consumption of mixed meal
Time Frame
time (minutes)=-15, -5, 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 420, 480
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary Frost
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
NIHR/Wellcome Trust Imperial Clinical Research Facility
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://imperial.crf.nihr.ac.uk/
Description
Clinical Research Facility official web page
Learn more about this trial
Effect of Palm Olein Intake on Lipid Profile and Appetite Regulation
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