The InterSat Study (NCT04418102) | Clinical Trial Compass
CompletedNot Applicable
The InterSat Study
Netherlands, United Kingdom51 participantsStarted 2020-02-01
Plain-language 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. 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.
Who can participate
Age range
35 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* 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 du…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline in fasting total:HDL cholesterol ratio