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High-fat challenge induced trained innate immunity

High-fat challenge induced trained innate immunity - The SHAKE study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON47993
Enrollment
16
Registered
2019-02-12
Start date
2019-05-06
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

atherosclerosis

Interventions

A single high-fat challenge (milkshake containing 95g of fat) and *control* shake (comparable to an average breakfast).

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age between 18 and 40 years LDL cholesterol

Exclusion criteria

Exclusion criteria: Smoking within the year before study entry Diagnosed with any long-term medical condition that can interfere with the study (i.e. renal failure, galbladder disease, cardiovascular disease, diabetes, rheumatoid arthritis etc.) Medication (with the exception of oral contraceptives) or supplement use (i.e. omega3) BMI 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 alcohol or drugs Vegetarian diet

Design outcomes

Primary

MeasureTime frame
Blood will be drawn at t=0h (before) and at t=1h, t=2h, t=4h, t=6h, t=24 and t=72h after an oral fat load and at the same time points after a *control* shake. The primary endpoint is the monocyte TNFa production upon ex vivo stimulation with LPS (TLR4 ligand) at t=72h.

Secondary

MeasureTime frame
Additional secondary endpoints are the monocytes* inflammatory phenotype as assessed by flowcytometry analysis , epigenetic and metabolic reprogramming and serum induced inflammation.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)