Healthy AdultsINTERMETNCT03191513
The Acute Effects of Interesterification of Commercially Used Fats on Postprandial Fat Metabolism
A study testing Interesterified blend of palm kernal and plam stearin, Un-interesterified blend of palm kernal and plam stearin and Rapeseed oil in people with Healthy Adults and Postmenopausal Women, run by King's College London at 1 site in United Kingdom.
Trial summary
The purpose of this study is to investigate whether there are differences in postprandial metabolic indices following interesterified fats used commercially versus the corresponding un-interesterified blend. Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults, Postmenopausal Women
- What is being tested?
- Interesterified blend of palm kernal and plam stearin, Un-interesterified blend of palm kernal and plam stearin and Rapeseed oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Jun 2017to 27 May 2018
- 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 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females aged 45-75 years
- Healthy (free of diagnosed diseases listed in exclusion criteria)
- Able to understand the information sheet and willing to comply with study protocol
- Able to give informed consent
Who cannot join
- Medical history of myocardial infarction, angina, thrombosis, stroke, cancer, liver or bowel disease or diabetes
- Body mass index < 20 kg/m2 or > 35 kg/m2
- Plasma cholesterol ≥7.5 mmol/L
- Plasma triacylglycerol > 3 mmol/L
- Plasma glucose > 7 mmol/L
- Blood pressure ≥140/90 mmHg
Show all 11Show fewer
- Current use of antihypertensive or lipid lowering medications
- Premenopausal (for women)
- Alcohol intake exceeding a moderate intake (> 28 units per week)
- Current cigarette smoker (or quit withint the last 6 months)
- ≥ 20% 10-year risk of CVD as calculated using a risk calculator
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate whether there are differences in postprandial metabolic indices following interesterified fats used commercially versus the corresponding un-interesterified blend.
Read the detailed description
Aim: The current study aims to investigate the acute effects of commercially relevant interesterified 'hardstock' versus the corresponding un-interesterified blend on 8 h postprandial fat metabolism.
Hypothesis: Interesterification of a palm kernel and palm stearin fat blend, to produce a fat with a higher proportion of palmitic acid in the middle position of the triglyceride (TAG; but the same fatty acid composition), will alter postprandial lipid metabolism.
Subjects: Participants will include 24 healthy male and female (postmenopausal) volunteers aged between the ages of 45 and 75 years (since during this age metabolic changes start to take place).
Power calculation: Based on previous studies carried out by our group at King's College London, a sample size of 10 males and 10 females is required to detect a (clinically relevant) difference (for males and females separately) between means of 0.3 mmol/L maximal difference in 8 h plasma TAG concentration (standard deviation 0.33 mmol/L, significance level (alpha) of 0.05 and 80% power). 12 males and 12 females will be recruited to allow for a 20% drop out rate.
Expected value:The study will provide novel information on the acute effects of commercially relevant processed fats on postprandial lipaemia.
- Conditions
- Healthy Adults, Postmenopausal Women
- Being tested
- Interesterified blend of palm kernal and plam stearin, Un-interesterified blend of palm kernal and plam stearin, Rapeseed oil
- Keywords
- Interesterified, Postprandial, Lipid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interesterified blend of palm kernal and plam stearinDietary supplement
Also called Interesterified blend
50 g fat provided as interesterified palm kernal and palm sterin blend in a single meal (sub-group, n=12, also have 75 mg 13C labelled tripalmatin and 1.2 g / kg body water deuterated water)
Un-interesterified blend of palm kernal and plam stearinDietary supplement
Also called Un-interesterified blend
50 g fat provided as un-interesterified palm kernal and palm sterin blend in a single meal (sub-group, n=12, also have 75 mg 13C labelled tripalmatin and 1.2 g / kg body water deuterated water)
Rapeseed oilDietary supplement
Also called Control fat
50 g fat provided as rapeseed oil in a single meal (sub-group, n=12, also have 75 mg 13C labelled tripalmatin and 1.2 g / kg body water deuterated water)
| Study group | Role | What they receive |
|---|---|---|
| Interesterified | Experimental | Interesterified blend of palm kernal and plam stearin. 50g fat. Receives: Dietary Supplement: Interesterified blend of palm kernal and plam stearin |
| Un-interesterified | Active comparator | Un-interesterified blend of palm kernal and plam stearin. 50g fat. Receives: Dietary Supplement: Un-interesterified blend of palm kernal and plam stearin |
| Control | Active comparator | Rapeseed oil. 50g fat. Receives: Dietary Supplement: Rapeseed oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under plasma TAG concentration/ time curve
Postprandial area under plasma TAG concentration/ time curve
Measured: Up to 8 hours
Secondary outcomes (2)
Postprandial lipaemic response
Postprandial plamsa total fatty acid composition and non esterifed fatty acid
Measured: Up to 8 hours
Positional composition retention (chylomicron)
Postprandial chylomicron TAG concentration and composition, TAG sn-2 fatty acid composition, total protein, apoB100 and apoB48
Measured: Up to 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2017
- Study start12 Jun 2017
- Primary completion15 May 2018
- Study completion27 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy AdultsStudies of the same condition, open and under way.
- More trials run by King's 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah EE Berry, PhD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03191513
- Sponsor's protocol ID
- HR-16/17-4397
- Acronym
- INTERMET
- Status last verified
- May 2017
- First submitted
- 23 May 2017
- Last updated
- 26 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Burnap SA, Sattler K, Pechlaner R, Duregotti E, Lu R, Theofilatos K, Takov K, Heusch G, Tsimikas S, Fernandez-Hernando C, Berry SE, Hall WL, Notdurfter M, Rungger G, Paulweber B, Willeit J, Kiechl S, Levkau B, Mayr M. PCSK9 Activity Is Potentiated Through HDL Binding. Circ Res. 2021 Nov 12;129(11):1039-1053. doi: 10.1161/CIRCRESAHA.121.319272. Epub 2021 Oct 4.
PubMed 34601896
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Effects of Interesterification of Commercially Used Fats on Postprandial Fat Metabolism
- ClinicalTrials.gov ID
- NCT03191513
- Acronym / sponsor ID
- INTERMET / HR-16/17-4397
- Conditions
- Healthy Adults, Postmenopausal Women
- Keywords
- Interesterified, Postprandial, Lipid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 12 Jun 2017 (actual)
- Primary completion
- 15 May 2018 (actual)
- Study completion
- 27 May 2018 (actual)
- First posted
- 19 Jun 2017 (actual)
- 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.
The purpose of this study is to investigate whether there are differences in postprandial metabolic indices following interesterified fats used commercially versus the corresponding un-interesterified blend.
Detailed description
Aim: The current study aims to investigate the acute effects of commercially relevant interesterified 'hardstock' versus the corresponding un-interesterified blend on 8 h postprandial fat metabolism.
Hypothesis: Interesterification of a palm kernel and palm stearin fat blend, to produce a fat with a higher proportion of palmitic acid in the middle position of the triglyceride (TAG; but the same fatty acid composition), will alter postprandial lipid metabolism.
Subjects: Participants will include 24 healthy male and female (postmenopausal) volunteers aged between the ages of 45 and 75 years (since during this age metabolic changes start to take place).
Power calculation: Based on previous studies carried out by our group at King's College London, a sample size of 10 males and 10 females is required to detect a (clinically relevant) difference (for males and females separately) between means of 0.3 mmol/L maximal difference in 8 h plasma TAG concentration (standard deviation 0.33 mmol/L, significance level (alpha) of 0.05 and 80% power). 12 males and 12 females will be recruited to allow for a 20% drop out rate.
Expected value:The study will provide novel information on the acute effects of commercially relevant processed fats on postprandial lipaemia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Interesterified | Experimental | Dietary Supplement: Interesterified blend of palm kernal and plam stearinInteresterified blend of palm kernal and plam stearin. 50g fat. |
| Un-interesterified | Active comparator | Dietary Supplement: Un-interesterified blend of palm kernal and plam stearinUn-interesterified blend of palm kernal and plam stearin. 50g fat. |
| Control | Active comparator | Dietary Supplement: Rapeseed oilRapeseed oil. 50g fat. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and females aged 45-75 years
- Healthy (free of diagnosed diseases listed in exclusion criteria)
- Able to understand the information sheet and willing to comply with study protocol
- Able to give informed consent
Key exclusion criteria (11 listed)
- Medical history of myocardial infarction, angina, thrombosis, stroke, cancer, liver or bowel disease or diabetes
- Body mass index < 20 kg/m2 or > 35 kg/m2
- Plasma cholesterol ≥7.5 mmol/L
- Plasma triacylglycerol > 3 mmol/L
- Plasma glucose > 7 mmol/L
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 |
|---|---|---|
| Interesterified blend of palm kernal and plam stearinAlso: Interesterified blend50 g fat provided as interesterified palm kernal and palm sterin blend in a single meal (sub-group, n=12, also have 75 mg 13C labelled tripalmatin and 1.2 g / kg body water deuterated water) | Dietary supplement | Interesterified |
| Un-interesterified blend of palm kernal and plam stearinAlso: Un-interesterified blend50 g fat provided as un-interesterified palm kernal and palm sterin blend in a single meal (sub-group, n=12, also have 75 mg 13C labelled tripalmatin and 1.2 g / kg body water deuterated water) | Dietary supplement | Un-interesterified |
| Rapeseed oilAlso: Control fat50 g fat provided as rapeseed oil in a single meal (sub-group, n=12, also have 75 mg 13C labelled tripalmatin and 1.2 g / kg body water deuterated water) | Dietary supplement | Control |
Primary outcome
Area under plasma TAG concentration/ time curve
Time frame: Up to 8 hours
Postprandial area under plasma TAG concentration/ time curve
2 secondary outcomes
Postprandial lipaemic response
Time frame: Up to 8 hours
Positional composition retention (chylomicron)
Time frame: Up to 6 hours
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 26 Oct 2020.
- Derived from this study: PubMed 34601896Burnap SA, Sattler K, Pechlaner R, Duregotti E, Lu R, Theofilatos K, Takov K, Heusch G, Tsimikas S, Fernandez-Hernando C, Berry SE, Hall WL, Notdurfter M, Rungger G, Paulweber B, Willeit J, Kiechl S, Levkau B, Mayr M. PCSK9 Activity Is Potentiated Through HDL Binding. Circ Res. 2021 Nov 12;129(11):1039-1053. doi: 10.1161/CIRCRESAHA.121.319272. Epub 2021 Oct 4.
- Individual participant dataSharing planned: No
Related trials for Healthy Adults
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1/2
Clinical Trial to Assess the Safety, Tolerability, Reactogenicity, and Immunogenicity of a 10 Valent Human Papillomavirus Virus (10vHPV) Vaccine
Human Papillomavirus Infection
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
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.
Sarah EE Berry, PhD principal investigator
King's 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 Interesterified blend of palm kernal and plam stearin, Un-interesterified blend of palm kernal and plam stearin and Rapeseed oil in people with Healthy Adults and Postmenopausal Women, run by King's 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 4 inclusion and 11 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 26 Oct 2020. 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?
Area under plasma TAG concentration/ time curve (time frame: Up to 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03191513, which also lists 1 linked publication.
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 26 Oct 2020.