Status:
COMPLETED
The InterSat Study
Lead Sponsor:
King's College London
Collaborating Sponsors:
Maastricht University
Conditions:
Cardiometabolic Health
Eligibility:
All Genders
35-65 years
Phase:
NA
Brief 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) ...
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 sna...
Eligibility Criteria
Inclusion
- 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
- 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 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
Key Trial Info
Start Date :
February 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 25 2022
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT04418102
Start Date
February 1 2020
End Date
August 25 2022
Last Update
April 19 2023
Active Locations (2)
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1
Maastricht University
Maastricht, Netherlands, 616 6200
2
Department of Nutritional Sciences, King's College London. Franklin-Wilkins Buiding. Waterloo Campus
London, England, United Kingdom, SE1 9NH