Healthy AdultsINTER-CARDIONCT03438084
The INTER-CARDIO Study: The Impact of Commonly Consumed Fat on Cardiovascular Health; a Randomised Controlled Trial
A study testing Interesterified fat, Non- interesterified fat and Rapeseed oil in people with Healthy Adults, run by King's College London at 2 sites in United Kingdom.
Trial summary
The purpose of this study is to investigate whether there are differences in postprandial cardiometabolic metabolic indices following interesterified fats used commercially versus application appropriate non- interesterifed alternative fat. Read more about this study
- Who is it for?
- Ages 35 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- Interesterified fat, Non- interesterified fat and Rapeseed oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Jul 2018to 31 Oct 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 35 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females aged 35-75 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 10Show fewer
- Current use of antihypertensive or lipid lowering medications
- Alcohol intake exceeding a moderate intake (> 28 units per week)
- Current cigarette smoker (or quit within the last 6 months)
- ≥ 20% 10-year risk of CVD as calculated using a risk calculator
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Department of Nutritional Sciences, Faculty of Life Sciences and Medicine, Kings College London
London, SE1 9NH
King's College London
London, SE1 9NH
About this study
Official title: The INTER-CARDIO Study: The Impact of Commonly Consumed Fat on Cardiovascular
The purpose of this study is to investigate whether there are differences in postprandial cardiometabolic metabolic indices following interesterified fats used commercially versus application appropriate non- interesterifed alternative fat.
Read the detailed description
Aim: The current study aims to investigate the acute effects of commercially available interesterified fat versus versus application appropriate non- interesterifed alternative fat on 8 h postprandial cardiometabolic outcomes.
Hypothesis: Interesterified fat will induce a different cardiomtabolic response compared to a non interesterifed, application appropriate fat.
Subjects: Participants will include 40 healthy male and female volunteers aged between the ages of 35 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 20 participants (males and females separately) will allow a 2.16% (percentage unit) difference in FMD to be detected (90% power, 0.05 alpha, SD 2.9. 50 participants will be recruited allowing for a 20% dropout rate.
Expected value:The study will provide novel information on the acute effects of commercially relevant processed fats on postprandial lipaemia.
- Conditions
- Healthy Adults
- Being tested
- Interesterified fat, Non- interesterified fat, Rapeseed oil, Butter
- Keywords
- Interesterified, Postprandial, Lipid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interesterified fatDietary supplement
50 g fat provided as commercially available interesterified fat.
Non- interesterified fatDietary supplement
50 g fat provided as commercially available non-interesterified fat.
Rapeseed oilDietary supplement
50 g fat provided as commercially available rapeseed oil.
ButterDietary supplement
50g fat provided as commercially available spreadable butter
| Study group | Role | What they receive |
|---|---|---|
| Interesterified | Experimental | Commercially available interesterifed fat spread. 50g fat. Receives: Dietary Supplement: Interesterified fat |
| Non- interesterified | Active comparator | Commercially available non-interesterified fat. 50g fat. Receives: Dietary Supplement: Non- interesterified fat |
| Control | Active comparator | Rapeseed oil. 50 g fat. Receives: Dietary Supplement: Rapeseed oil |
| Saturated fat control | Active comparator | Butter. 50g fat Receives: Dietary Supplement: Butter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial function
Flow mediated dilatation
Measured: Up to 8 hours
Postprandial lipaemic response
Area under plasma TAG concentration/ time curve
Measured: Up to 8 hours
Secondary outcomes (7)
Postprandial lipaemic response
Postprandial plamsa total fatty acid composition and non esterifed fatty acid
Measured: Up to 8 hours
Metabolomic for assessment of atherogenic potential (lipoprotein) analysis
Lipid concentrations and compositions of 14 lipoprotein subclasses, measured by NMR
Measured: Up to 8 hours
Glycaemic response
Plasma glucose concentration
Measured: Up to 8 hours
Insulinaemic response
Plasma insulin concnetration
Measured: Up to 8 hours
Nitric oxide bioavailability
Plasma nitric oxide species and NADPH oxidase activity
Measured: Up to 8 hours
Oxidative stress
Plasma 8-isoprostane F2a
Measured: Up to 8 hours
Inflammatory response
Plasma IL-6
Measured: Up to 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start1 Jul 2018
- Primary completion1 Oct 2019
- Study completion31 Oct 2019
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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03438084
- Sponsor's protocol ID
- HR-
- Acronym
- INTER-CARDIO
- Status last verified
- Aug 2019
- First submitted
- 13 Feb 2018
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hall WL, Alkoblan A, Gibson PS, D'Annibale M, Coekaerts A, Bauer M, Bruce JH, Lecomte B, Penhoat A, Laugerette F, Michalski MC, Salt LJ, Wilde PJ, Berry SE. Postprandial lipid and vascular responses following consumption of a commercially-relevant interesterified palmitic acid-rich spread in comparison to functionally-equivalent non-interesterified spread and spreadable butter: a randomised controlled trial in healthy adults. Food Funct. 2024 Mar 4;15(5):2733-2750. doi: 10.1039/d3fo05324e.
PubMed 38380649
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The INTER-CARDIO Study: The Impact of Commonly Consumed Fat on Cardiovascular
- ClinicalTrials.gov ID
- NCT03438084
- Acronym / sponsor ID
- INTER-CARDIO / HR-
- Conditions
- Healthy Adults
- Keywords
- Interesterified, Postprandial, Lipid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 19 Feb 2018 (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 cardiometabolic metabolic indices following interesterified fats used commercially versus application appropriate non- interesterifed alternative fat.
Detailed description
Aim: The current study aims to investigate the acute effects of commercially available interesterified fat versus versus application appropriate non- interesterifed alternative fat on 8 h postprandial cardiometabolic outcomes.
Hypothesis: Interesterified fat will induce a different cardiomtabolic response compared to a non interesterifed, application appropriate fat.
Subjects: Participants will include 40 healthy male and female volunteers aged between the ages of 35 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 20 participants (males and females separately) will allow a 2.16% (percentage unit) difference in FMD to be detected (90% power, 0.05 alpha, SD 2.9. 50 participants will be recruited allowing for a 20% dropout 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
- 4
| Arm | Type | Receives |
|---|---|---|
| Interesterified | Experimental | Dietary Supplement: Interesterified fatCommercially available interesterifed fat spread. 50g fat. |
| Non- interesterified | Active comparator | Dietary Supplement: Non- interesterified fatCommercially available non-interesterified fat. 50g fat. |
| Control | Active comparator | Dietary Supplement: Rapeseed oilRapeseed oil. 50 g fat. |
| Saturated fat control | Active comparator | Dietary Supplement: ButterButter. 50g fat |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and females aged 35-75 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 (10 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 fat50 g fat provided as commercially available interesterified fat. | Dietary supplement | Interesterified |
| Non- interesterified fat50 g fat provided as commercially available non-interesterified fat. | Dietary supplement | Non- interesterified |
| Rapeseed oil50 g fat provided as commercially available rapeseed oil. | Dietary supplement | Control |
| Butter50g fat provided as commercially available spreadable butter | Dietary supplement | Saturated fat control |
Primary outcome
Endothelial function
Time frame: Up to 8 hours
Flow mediated dilatation
Postprandial lipaemic response
Time frame: Up to 8 hours
Area under plasma TAG concentration/ time curve
7 secondary outcomes
Postprandial lipaemic response
Time frame: Up to 8 hours
Metabolomic for assessment of atherogenic potential (lipoprotein) analysis
Time frame: Up to 8 hours
Glycaemic response
Time frame: Up to 8 hours
Insulinaemic response
Time frame: Up to 8 hours
Nitric oxide bioavailability
Time frame: Up to 8 hours
Oxidative stress
Time frame: Up to 8 hours
Inflammatory response
Time frame: Up to 8 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 27 Jan 2020.
- Derived from this study: PubMed 38380649Hall WL, Alkoblan A, Gibson PS, D'Annibale M, Coekaerts A, Bauer M, Bruce JH, Lecomte B, Penhoat A, Laugerette F, Michalski MC, Salt LJ, Wilde PJ, Berry SE. Postprandial lipid and vascular responses following consumption of a commercially-relevant interesterified palmitic acid-rich spread in comparison to functionally-equivalent non-interesterified spread and spreadable butter: a randomised controlled trial in healthy adults. Food Funct. 2024 Mar 4;15(5):2733-2750. doi: 10.1039/d3fo05324e.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interesterified fat, Non- interesterified fat and Rapeseed oil in people with Healthy Adults, run by King's College London at 2 sites 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 10 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 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Endothelial function (time frame: Up to 8 hours). The study lists 2 primary outcomes in all. 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 NCT03438084, 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 27 Jan 2020.