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Completed
NCT05682456
High-fat Challenge Induced Trained Innate Immunity (SHAKE Study)
Conditions: Cardiovascular Diseases
Sex: All
Ages: 18 Years – 40 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 16
Sponsor: Radboud University Medical Center
Location: Netherlands
Summary
The goal of this randomized controlled cross-over trial is to investigate whether a single high-fat challenge can induce trained innate immunity in healthy volunteers.
The main question it aims to answer is: Can a single high-fat challenge induce a persistent pro-inflammatory and pro-atherogenic monocyte phenotype, as detected by an augmented cytokine production capacity?
To study this, participants will receive an oral high-fat and reference shake in a cross-over design and blood will be drawn before and at 1, 2, 4, 6, 24, and 72 hours after the shakes.
Eligibility Criteria
Inclusion Criteria:LDL cholesterol < 3.5 mmol/l, fasting triglycerides < 2 mmol/lNo previous cardiovascular eventsExclusion Criteria:Smoking within the year before study entryDiagnosed with any long-term medical condition that can interfere with the study (i.e.gallbladder disease, renal failure, cardiovascular disease, diabetes, rheumatoid arthritis etc.)Medication (with the exception of oral contraceptives) or supplement use (i.e.
omega3)BMI < 18 or > 27 kg/m2Previous vaccination within 3 months prior to study entryCurrent infection or clinically significant infections within 1 month before study entry (defined as fever > 38.5°C)Allergic to cow milk/dairy productsPregnancy/lactationAbuse of drugs or alcoholVegetarian diet
Source: ClinicalTrials.gov (NCT05682456). StuddyBuddy aggregates publicly available trial information.