Cardiometabolic HealthInterSatNCT04418102
The InterSat Study
A study testing Palmitic acid rich interesterified fat and Stearic acid rich interesterified fat in people with Cardiometabolic Health, run by King's College London at 2 sites in 2 countries.
Trial summary
In response to the removal of trans fats from our foods, the food industry now uses interesterified (IE) fats. Randomly interesterified (IE) fats rich in palmitic (Europe) and stearic (North America) acids are the most commonly used IE fats by the food industry. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiometabolic Health
- What is being tested?
- Palmitic acid rich interesterified fat and Stearic acid rich interesterified fat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Feb 2020to 25 Aug 2022
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy (free of diagnosed diseases listed in exclusion criteria).
- Able to give informed consent.
- Able to give informed consent.
- Accessible veins on arms as determined by examination at screening
Who cannot join
- Having a medical condition or history which might impact study measurements, to be judged by the study physician (e.g. myocardial infarction, angina, thrombosis, stroke, cancer, liver or bowel disease or diabetes)
- Use of plant-sterol/stanol-enriched foods or supplements in the three months prior to the screening and/or during the study
- 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
Show all 19Show fewer
- Full blood count (FBC), liver function out of healthy range
- Blood pressure ≥140/90 mmHg
- Current use of antihypertensive or lipid lowering medications
- Use of over-the-counter and prescribed medication, which may interfere with study measurements (to be judged by the principal investigator)
- Alcohol intake exceeding a moderate intake (> 21 units per week)
- Current cigarette smoker (or quit within last 6 months)
- ≥ 20% 10-year risk of cardiovascular disease (CVD) as calculated using a risk calculator
- Active blood donor or plans to donate blood within 6 months of study completion
- Use of oral antibiotics (with the exception of topical antibiotics) in 40 days or less prior to the start of the study
- Reported weight loss or gain of 3 kg or more during a period of 2 months prior to screening
- Reported dietary habits: medically prescribed diet, allergy/intolerance to test products that will be provided during the study
- Reported participation in another nutritional or biomedical trial 3 months prior to screening
- Reported participation in night shift work 2 weeks prior to screening and/or during the study. Night work is defined as working between midnight and 6.00 am Anyone who has given blood in the last 3 months
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United Kingdom1 site
Department of Nutritional Sciences, King's College London. Franklin-Wilkins Buiding. Waterloo Campus
London, England, SE1 9NH
About this study
Official title: The InterSat Study: Interesterified Fats: Health Effects of Commercially Relevant Palmitic Versus Stearic Acid Rich Interesterified Fats
In response to the removal of trans fats from our foods, the food industry now uses interesterified (IE) fats. Randomly interesterified (IE) fats rich in palmitic (Europe) and stearic (North America) acids are the most commonly used IE fats by the food industry. Despite their widespread use, there has been no published research on the acute and chronic cardio-metabolic health effects of the most commonly consumed palmitic and stearic acid rich IE fats. The aim of InterSat is to investigate the postprandial and chronic effects of a diet rich in IE fats on cardiometabolic health.
Read the detailed description
Choice of design: A randomised crossover study with two arms, each arm consisting of a 6-week dietary intervention, separated by a 3-week (minimum) washout period.
Study population: Healthy adult snackers aged 35-65 years. 48 participants in total, 24 at each centre (see Locations).
Locations:
Metabolic Research Unit, Franklin-Wilkins Building, Waterloo Campus, King College London.
Metabolic Research Unit Maastricht, Academic Hospital Maastricht, Maastricht University.
Screening Assessment: Prospective participants will be selected based on the defined inclusion and exclusion criteria by the study management team. Recruitment will be done over the phone and via the Internet and emails and prospective participants will be booked in for their initial appointment to acquire baseline measurements.
Study duration: A 2-week run-in period, two 6-week dietary interventions, and a 3-week (minimum) washout period.
Dietary intervention: The InterSat intervention aims to provide 10% of total daily energy intake in the form of IE fat. These will be consumed in the form of muffins and spreads, designed to replace typically consumed snacks and spreads throughout the day. Energy requirements will be calculated using the Henry equation and physical activity levels (PAL).
At the baseline visit, participants will have and anthropometric measures and fasted blood samples taken, and will be assessed for endothelial function via flow mediated dilation (FMD), after which they will be provided with enough muffins and spread for a 2-week period, as well a study booklet (containing instructions and a diary to log muffin and spread consumption). They will receive guidance on how to incorporate the muffins and spread into their diet. Food collection dates will be set, and participants are then free to leave. At the second visit (first snack collection visit), no physical measures are taken, but the empty tubs and muffin cases are collected, and the study booklet is checked by a researcher to ensure the participant is compliant to the intervention. Any issues should be discussed, and guidance given to increase compliance if necessary. Another snack collection visit is booked. At the end of the 6-week intervention, participants will undergo physical and blood sampling as well as FMD, as with the baseline testing day. After a 3-week (minimum) washout period, the same procedures occur for the other arm of the trial.
Anthropometry: Weight, height, waist and hip circumference, blood pressure, body fat will be taken using standard procedures, in duplicates by a trained researcher at all face to face appointments.
Habitual food intake: Participants will complete the EPIC (European prospective investigation of cancer) food frequency questionnaire at the screening visit. They will also complete three 4-day diet diaries (one at the run-in period and one in each of the dietary intervention periods).
Blood samples: Fasting blood samples will be collected from a superficial antecubital vein via venepuncture before and after each dietary intervention. Postprandial blood samples will be taken via cannulation in a subgroup (see Subgroup below) for an 8-hour postprandial test day.
Participants will be asked to record and monitor the following information:
Amount of muffins and spread consumed (study booklet). Habitual intake (4-day diet diaries).
Subgroup: A subset (n = 24) of participants will undergo a postprandial test day at the baseline and 6-week points of each intervention arm. After baseline samples (anthropometrics, blood samples, FMD) are taken, participants will consume a breakfast containing a large bolus of the IE fat they are assigned to. Blood samples will be taken over an 8-hour testing period and FMD will be taken 2 more times. Liver fat will be assessed via MRI imaging (Maastricht only).
- Conditions
- Cardiometabolic Health
- Being tested
- Palmitic acid rich interesterified fat, Stearic acid rich interesterified fat
- Keywords
- Interesterified fat, Cardiometabolic health, Palmitic acid, Stearic acid, Vascular function, Postprandial lipaemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palmitic acid rich interesterified fatDietary supplement
Muffins and spread containing the palmitic acid rich IE fat will be consumed daily for a 6-week dietary intervention period
Stearic acid rich interesterified fatDietary supplement
Muffins and spread containing the palmitic acid rich IE fat will be consumed daily for a 6-week dietary intervention period.
| Study group | Role | What they receive |
|---|---|---|
| Palmitic acid rich interesterified fat | Experimental | Snacks (muffins) and spread containing palmitic acid rich interesterified fat to replace habitual snacks and spreads, and provide 10% of total daily energy intake with the interesterified fat. Receives: Dietary Supplement: Palmitic acid rich interesterified fat |
| Stearic acid rich interesterified fat | Active comparator | Snacks (muffins) and spread containing stearic acid rich interesterified fat to replace habitual snacks and spreads, and provide 10% of total daily energy intake with the interesterified fat. Receives: Dietary Supplement: Stearic acid rich interesterified fat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in fasting total:HDL cholesterol ratio
Total to high-density lipoprotein (Total:HDL) cholesterol ratio
Measured: 6 weeks
Secondary outcomes (13)
Postprandial lipaemia
Plasma triglyceride concentrations
Measured: Fasting, 60 min, 120 min, 180 min, 240 min, 300 min, 360 min, 420 min, 480 min following consumption of breakfast containing IE fats.
Endothelial function
Flow mediated dilation
Measured: Fasting, 270 min and 450 min following consumption of breakfast containing IE fats
Postprandial glucose homeostasis (Incremental area under the curve (iAUC) 0-240 min and 0-480 min)
Glucose, Insulin, C-peptide, Non-esterified fatty acids (NEFA)
Measured: Fasting, 30 min, 60 min, 120 min, 180 min, 240 min, 300 min, 360 min, 420 min, 480 min following consumption of breakfast containing IE fats.
Fasting Insulin sensitivity
Revised Quantitative Insulin Sensitivity Check Index (RQUICKI)
Measured: Fasting, 30 min, 60 min, 120 min, 180 min, 240 min, 300 min, 360 min, 420 min, 480 min following consumption of breakfast containing IE fats.
Change from baseline in liver fat (Maastricht only)
MRI (magnetic resonance imaging)
Measured: 6 weeks
Change from baseline in fasting total cholesterol
Fasting plasma total cholesterol concentrations
Measured: 6 weeks
Change from baseline in fasting LDL cholesterol
Fasting plasma low density lipoprotein cholesterol (LDL-C) concentrations
Measured: 6 weeks
Change from baseline in fasting Lp(a)
Fasting plasma lipoprotein a (Lp(a))
Measured: 6 weeks
Change from baseline in fasting apoA1
Fasting plasma apolipoprotein A1 (apoA1),
Measured: 6 weeks
Change from baseline in fasting apoB
Fasting plasma apolipoprotein B (apo B)
Measured: 6 weeks
Change from baseline in plasma total fatty acid composition
Fasting plasma total fatty acid composition
Measured: 6 weeks
Change from baseline in fasting glucose
Fasting plasma glucose concentrations
Measured: 6 weeks
Change from baseline in fasting insulin
Fasting plasma insulin concentrations
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start1 Feb 2020
- Primary completion25 Aug 2022
- Study completion25 Aug 2022
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 Cardiometabolic HealthStudies of the same condition, open and under way.
- 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
- Randomised controlled trial with 2x6 week interventions separated by a 3 week washout.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04418102
- Sponsor's protocol ID
- HR-19/20-14655
- Acronym
- InterSat
- Status last verified
- Apr 2023
- First submitted
- 19 Feb 2020
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hall WL, Wood E, Joris PJ, Smith HA, Creedon A, Maher T, Bruce JH, Mensink RP, Berry SE. The effects of consumption of interesterified fats rich in palmitic acid compared with stearic acid on intermediary markers of cardiometabolic disease risk: a randomized controlled trial in healthy adults. Am J Clin Nutr. 2025 Nov;122(5):1361-1373. doi: 10.1016/j.ajcnut.2025.09.025. Epub 2025 Sep 18.
PubMed 40975239
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The InterSat Study: Interesterified Fats: Health Effects of Commercially Relevant Palmitic Versus Stearic Acid Rich Interesterified Fats
- ClinicalTrials.gov ID
- NCT04418102
- Acronym / sponsor ID
- InterSat / HR-19/20-14655
- Conditions
- Cardiometabolic Health
- Keywords
- Interesterified fat, Cardiometabolic health, Palmitic acid, Stearic acid, Vascular function, Postprandial lipaemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Maastricht University
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 25 Aug 2022 (actual)
- Study completion
- 25 Aug 2022 (actual)
- First posted
- 5 Jun 2020 (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.
In response to the removal of trans fats from our foods, the food industry now uses interesterified (IE) fats. Randomly interesterified (IE) fats rich in palmitic (Europe) and stearic (North America) acids are the most commonly used IE fats by the food industry. Despite their widespread use, there has been no published research on the acute and chronic cardio-metabolic health effects of the most commonly consumed palmitic and stearic acid rich IE fats. The aim of InterSat is to investigate the postprandial and chronic effects of a diet rich in IE fats on cardiometabolic health.
Detailed description
Choice of design: A randomised crossover study with two arms, each arm consisting of a 6-week dietary intervention, separated by a 3-week (minimum) washout period.
Study population: Healthy adult snackers aged 35-65 years. 48 participants in total, 24 at each centre (see Locations).
Locations:
Metabolic Research Unit, Franklin-Wilkins Building, Waterloo Campus, King College London.
Metabolic Research Unit Maastricht, Academic Hospital Maastricht, Maastricht University.
Screening Assessment: Prospective participants will be selected based on the defined inclusion and exclusion criteria by the study management team. Recruitment will be done over the phone and via the Internet and emails and prospective participants will be booked in for their initial appointment to acquire baseline measurements.
Study duration: A 2-week run-in period, two 6-week dietary interventions, and a 3-week (minimum) washout period.
Dietary intervention: The InterSat intervention aims to provide 10% of total daily energy intake in the form of IE fat. These will be consumed in the form of muffins and spreads, designed to replace typically consumed snacks and spreads throughout the day. Energy requirements will be calculated using the Henry equation and physical activity levels (PAL).
At the baseline visit, participants will have and anthropometric measures and fasted blood samples taken, and will be assessed for endothelial function via flow mediated dilation (FMD), after which they will be provided with enough muffins and spread for a 2-week period, as well a study booklet (containing instructions and a diary to log muffin and spread consumption). They will receive guidance on how to incorporate the muffins and spread into their diet. Food collection dates will be set, and participants are then free to leave. At the second visit (first snack collection visit), no physical measures are taken, but the empty tubs and muffin cases are collected, and the study booklet is checked by a researcher to ensure the participant is compliant to the intervention. Any issues should be discussed, and guidance given to increase compliance if necessary. Another snack collection visit is booked. At the end of the 6-week intervention, participants will undergo physical and blood sampling as well as FMD, as with the baseline testing day. After a 3-week (minimum) washout period, the same procedures occur for the other arm of the trial.
Anthropometry: Weight, height, waist and hip circumference, blood pressure, body fat will be taken using standard procedures, in duplicates by a trained researcher at all face to face appointments.
Habitual food intake: Participants will complete the EPIC (European prospective investigation of cancer) food frequency questionnaire at the screening visit. They will also complete three 4-day diet diaries (one at the run-in period and one in each of the dietary intervention periods).
Blood samples: Fasting blood samples will be collected from a superficial antecubital vein via venepuncture before and after each dietary intervention. Postprandial blood samples will be taken via cannulation in a subgroup (see Subgroup below) for an 8-hour postprandial test day.
Participants will be asked to record and monitor the following information:
Amount of muffins and spread consumed (study booklet). Habitual intake (4-day diet diaries).
Subgroup: A subset (n = 24) of participants will undergo a postprandial test day at the baseline and 6-week points of each intervention arm. After baseline samples (anthropometrics, blood samples, FMD) are taken, participants will consume a breakfast containing a large bolus of the IE fat they are assigned to. Blood samples will be taken over an 8-hour testing period and FMD will be taken 2 more times. Liver fat will be assessed via MRI imaging (Maastricht only).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised controlled trial with 2x6 week interventions separated by a 3 week washout.
| Arm | Type | Receives |
|---|---|---|
| Palmitic acid rich interesterified fat | Experimental | Dietary Supplement: Palmitic acid rich interesterified fatSnacks (muffins) and spread containing palmitic acid rich interesterified fat to replace habitual snacks and spreads, and provide 10% of total daily energy intake with the interesterified fat. |
| Stearic acid rich interesterified fat | Active comparator | Dietary Supplement: Stearic acid rich interesterified fatSnacks (muffins) and spread containing stearic acid rich interesterified fat to replace habitual snacks and spreads, and provide 10% of total daily energy intake with the interesterified fat. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy (free of diagnosed diseases listed in exclusion criteria).
- Able to give informed consent.
- Able to give informed consent.
- Accessible veins on arms as determined by examination at screening
Key exclusion criteria (19 listed)
- Having a medical condition or history which might impact study measurements, to be judged by the study physician (e.g. myocardial infarction, angina, thrombosis, stroke, cancer, liver or bowel disease or diabetes)
- Use of plant-sterol/stanol-enriched foods or supplements in the three months prior to the screening and/or during the study
- Body mass index < 20 kg/m2 or > 35 kg/m2
- Plasma cholesterol ≥7.5 mmol/L
- Plasma triacylglycerol > 3 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 |
|---|---|---|
| Palmitic acid rich interesterified fatMuffins and spread containing the palmitic acid rich IE fat will be consumed daily for a 6-week dietary intervention period | Dietary supplement | Palmitic acid rich interesterified fat |
| Stearic acid rich interesterified fatMuffins and spread containing the palmitic acid rich IE fat will be consumed daily for a 6-week dietary intervention period. | Dietary supplement | Stearic acid rich interesterified fat |
Primary outcome
Change from baseline in fasting total:HDL cholesterol ratio
Time frame: 6 weeks
Total to high-density lipoprotein (Total:HDL) cholesterol ratio
13 secondary outcomes
Postprandial lipaemia
Time frame: Fasting, 60 min, 120 min, 180 min, 240 min, 300 min, 360 min, 420 min, 480 min following consumption of breakfast containing IE fats.
Endothelial function
Time frame: Fasting, 270 min and 450 min following consumption of breakfast containing IE fats
Postprandial glucose homeostasis (Incremental area under the curve (iAUC) 0-240 min and 0-480 min)
Time frame: Fasting, 30 min, 60 min, 120 min, 180 min, 240 min, 300 min, 360 min, 420 min, 480 min following consumption of breakfast containing IE fats.
Fasting Insulin sensitivity
Time frame: Fasting, 30 min, 60 min, 120 min, 180 min, 240 min, 300 min, 360 min, 420 min, 480 min following consumption of breakfast containing IE fats.
Change from baseline in liver fat (Maastricht only)
Time frame: 6 weeks
Change from baseline in fasting total cholesterol
Time frame: 6 weeks
Change from baseline in fasting LDL cholesterol
Time frame: 6 weeks
Change from baseline in fasting Lp(a)
Time frame: 6 weeks
Change from baseline in fasting apoA1
Time frame: 6 weeks
Change from baseline in fasting apoB
Time frame: 6 weeks
Change from baseline in plasma total fatty acid composition
Time frame: 6 weeks
Change from baseline in fasting glucose
Time frame: 6 weeks
Change from baseline in fasting insulin
Time frame: 6 weeks
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 19 Apr 2023.
- Derived from this study: PubMed 40975239Hall WL, Wood E, Joris PJ, Smith HA, Creedon A, Maher T, Bruce JH, Mensink RP, Berry SE. The effects of consumption of interesterified fats rich in palmitic acid compared with stearic acid on intermediary markers of cardiometabolic disease risk: a randomized controlled trial in healthy adults. Am J Clin Nutr. 2025 Nov;122(5):1361-1373. doi: 10.1016/j.ajcnut.2025.09.025. Epub 2025 Sep 18.
- 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 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Palmitic acid rich interesterified fat and Stearic acid rich interesterified fat in people with Cardiometabolic Health, run by King's College London at 2 sites in 2 countries.
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 19 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 19 Apr 2023. 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 Netherlands, 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 fasting total:HDL cholesterol ratio (time frame: 6 weeks). 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 NCT04418102, 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 19 Apr 2023.