The InterSat Study

Launched by KING'S COLLEGE LONDON · Jun 2, 2020

Keywords

ClinConnect Summary

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 ...

Gender

ALL

Eligibility criteria

• 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 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