CompletedNot Applicable

High-fat Challenge Induced Trained Innate Immunity (SHAKE Study)

Netherlands16 participantsStarted 2019-05-06

Plain-language 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.

Who can participate

Age range18 Years – 40 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * LDL cholesterol \< 3.5 mmol/l, fasting triglycerides \< 2 mmol/l * No previous cardiovascular events Exclusion Criteria: * Smoking within the year before study entry * Diagnosed 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/m2 * Previous vaccination within 3 months prior to study entry * Current infection or clinically significant infections within 1 month before study entry (defined as fever \> 38.5°C) * Allergic to cow milk/dairy products * Pregnancy/lactation * Abuse of drugs or alcohol * Vegetarian diet

What they're measuring

Monocyte TNFα production upon ex vivo stimulation with LPS

Timeframe: 72 hours

Trial details

NCT IDNCT05682456

SponsorRadboud University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-01-09