Healthy VolunteersPalmOilNCT02897674
Effect of Palm Olein Intake on Lipid Profile and Fat Deposition
A study testing Palm olein, Interesterified palm olein and soybean oil in people with Healthy Volunteers, run by Imperial College London at 1 site in United Kingdom.
Trial summary
Aims: To investigate whether diet with realistic doses on palm oil will have an effect on lipid profile and fat deposition in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Palm olein, Interesterified palm olein and soybean oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2016to Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
NIHR/Wellcome Trust Imperial Clinical Research Facility
London, W12 0HS
About this study
Official title: The Chemical Structure of a Lipid Determines Its Effect on Blood Lipid Profile and Fat Deposition
Aims: To investigate whether diet with realistic doses on palm oil will have an effect on lipid profile and fat deposition in healthy volunteers.
Read the 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.
- Conditions
- Healthy Volunteers
- Being tested
- Palm olein, Interesterified palm olein, soybean oil
- Keywords
- palm oil, lipid profile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palm oleinDietary supplement
two thirds of the 30% fat calories will come from palm olein
Interesterified palm oleinDietary supplement
two thirds of the 30% fat calories will come from interesterified palm olein
soybean oilDietary supplement
two thirds of the 30% fat calories will come from soybean oil
| Study group | Role | What they receive |
|---|---|---|
| Normal weight | Experimental | 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 Receives: Dietary Supplement: Palm olein; Dietary Supplement: Interesterified palm olein; Dietary Supplement: soybean oil |
| Overweight | Experimental | 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 Receives: Dietary Supplement: Palm olein; Dietary Supplement: Interesterified palm olein; Dietary Supplement: soybean oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in total cholesterol following the supplementation
Measured: fasting measure in week 3, 6, 10, 14
Secondary outcomes (3)
Change from baseline in body composition
total and regional body composition assessed by MRI
Measured: Fasting measure in week 3 and week 14
Change from baseline in lipoproteins
Measured: time=0 in week 3, 6, 10, 14
Postprandial change in appetite hormones
Measured: time=-15, -5,15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 420, 480 in week 3 and week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study startFeb 2016
- Primary completionAug 2019
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Malaysia Palm Oil Board
- Responsible party
- Sponsor
- Investigators
- Gary Frost, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02897674
- Sponsor's protocol ID
- 15HH2616
- Acronym
- PalmOil
- Status last verified
- Oct 2019
- First submitted
- 17 Aug 2016
- Last updated
- 17 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Chemical Structure of a Lipid Determines Its Effect on Blood Lipid Profile and Fat Deposition
- ClinicalTrials.gov ID
- NCT02897674
- Acronym / sponsor ID
- PalmOil / 15HH2616
- Conditions
- Healthy Volunteers
- Keywords
- palm oil, lipid profile
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Malaysia Palm Oil Board
- Study start
- Feb 2016 (actual)
- Primary completion
- Aug 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 13 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aims: To investigate whether diet with realistic doses on palm oil will have an effect on lipid profile and fat deposition in healthy volunteers.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal weight | Experimental | Dietary Supplement: Palm olein, Dietary Supplement: Interesterified palm olein, Dietary Supplement: soybean oilParticipants 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 |
| Overweight | Experimental | Dietary Supplement: Palm olein, Dietary Supplement: Interesterified palm olein, Dietary Supplement: soybean oilParticipants 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Palm oleintwo thirds of the 30% fat calories will come from palm olein | Dietary supplement | Normal weight, Overweight |
| Interesterified palm oleintwo thirds of the 30% fat calories will come from interesterified palm olein | Dietary supplement | Normal weight, Overweight |
| soybean oiltwo thirds of the 30% fat calories will come from soybean oil | Dietary supplement | Normal weight, Overweight |
Primary outcome
Change from baseline in total cholesterol following the supplementation
Time frame: fasting measure in week 3, 6, 10, 14
3 secondary outcomes
Change from baseline in body composition
Time frame: Fasting measure in week 3 and week 14
Change from baseline in lipoproteins
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary Frost principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Palm olein, Interesterified palm olein and soybean oil in people with Healthy Volunteers, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in total cholesterol following the supplementation (time frame: fasting measure in week 3, 6, 10, 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2019.