LipidaemiaAPONCT02924896
Effect of Palm Olein Intake on Lipid Profile and Appetite Regulation
A study testing Palm olein, Interesterified palm olein and Soybean oil in people with Lipidaemia, run by Imperial College London at 1 site in United Kingdom.
Trial summary
Aims: To investigate whether acute ingestions of palm oil will have an effect on appetite regulation Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Lipidaemia
- 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
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2016to Apr 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 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)
Who cannot join
- 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
Show all 13Show fewer
- 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
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 Appetite Regulation
Aims: To investigate whether acute ingestions of palm oil will have an effect on appetite regulation
Read the 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.
- Conditions
- Lipidaemia
- Being tested
- Palm olein, Interesterified palm olein, Soybean oil
- Keywords
- palm oil, apetite regulation
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palm oleinDietary supplement
60g of palm olein will be given in a milkshake at breakfast
Interesterified palm oleinDietary supplement
60g of interesterified palm olein will be given in a milkshake at breakfast
Soybean oilDietary supplement
60g of soybean oil will be given in a milkshake at breakfast
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Palm Olein Receives: Dietary Supplement: Palm olein; Dietary Supplement: Interesterified palm olein; Dietary Supplement: Soybean oil |
| Arm 2 | Other | Soybean Oil Receives: Dietary Supplement: Palm olein; Dietary Supplement: Interesterified palm olein; Dietary Supplement: Soybean oil |
| Arm 3 | Other | Interesterified Palm Olein 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 Appetite Hormones PYY
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.
Measured: 480 minutes
Secondary outcomes (2)
Change From Baseline in Glucose,
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
Measured: 480 min
Change From Baseline in Appetite Hormones GLP_1
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.
Measured: ime (minutes)=-15, -5, 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 420, 480. Time Frame: 480 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study startSep 2016
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LipidaemiaStudies 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
- Crossover
- Model description
- Number of participants 12
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 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
- NCT02924896
- Sponsor's protocol ID
- 16/WA/0117
- Acronym
- APO
- Status last verified
- Jun 2025
- First submitted
- 28 Sep 2016
- Last updated
- 22 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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 22 Jun 2025. 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 Appetite Regulation
- ClinicalTrials.gov ID
- NCT02924896
- Acronym / sponsor ID
- APO / 16/WA/0117
- Conditions
- Lipidaemia
- Keywords
- palm oil, apetite regulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Malaysia Palm Oil Board
- Study start
- Sep 2016
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 5 Oct 2016 (estimated)
- Results
- Posted 22 Jun 2025
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 acute ingestions of palm oil will have an effect on appetite regulation
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Number of participants 12
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Dietary Supplement: Palm olein, Dietary Supplement: Interesterified palm olein, Dietary Supplement: Soybean oilPalm Olein |
| Arm 2 | Other | Dietary Supplement: Palm olein, Dietary Supplement: Interesterified palm olein, Dietary Supplement: Soybean oilSoybean Oil |
| Arm 3 | Other | Dietary Supplement: Palm olein, Dietary Supplement: Interesterified palm olein, Dietary Supplement: Soybean oilInteresterified Palm Olein |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (13 listed)
- 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
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 olein60g of palm olein will be given in a milkshake at breakfast | Dietary supplement | Arm 1, Arm 2, Arm 3 |
| Interesterified palm olein60g of interesterified palm olein will be given in a milkshake at breakfast | Dietary supplement | Arm 1, Arm 2, Arm 3 |
| Soybean oil60g of soybean oil will be given in a milkshake at breakfast | Dietary supplement | Arm 1, Arm 2, Arm 3 |
Primary outcome
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.
2 secondary outcomes
Change From Baseline in Glucose,
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 Lipidaemia, 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 13 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 22 Jun 2025. 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?
Yes. Results are posted in the registry (first posted 22 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Appetite Hormones PYY (time frame: 480 minutes). 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 22 Jun 2025.