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Evaluating the effects of acute LPS exposure on Energy metabolism and Substrate utilization as well as markers reflecting lipid and glucose metabolism: The LES trial

Evaluating the effects of acute LPS exposure on Energy metabolism and Substrate utilization as well as markers reflecting lipid and glucose metabolism: The LES trial - LPS, energy metabolism and substrate utilization

Status
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON54328
Enrollment
12
Registered
2021-12-13
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-08

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

Conditions

Energieverbruik energy use Metabolic rate

Interventions

None listed

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: • Provision of signed and dated informed consent prior to any study specific procedures • Willingness to comply with study protocol • Apparently healthy men and women as judged by the study physician • Non-smoking • Aged between 18 and 35 years • BMI >=20 and

Exclusion criteria

Exclusion criteria: • Having a medical condition or use of medication which might lead to an intensified response towards LPS exposure to be judged by the study physician • 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 over-the-counter and prescribed medication, which may interfere with study measurements (to be judged by the principal investigator and physician) • Use of oral antibiotics (with the exception of topical antibiotics) in 40 days or less prior to the start of the study • Current use of antihypertensive, antidiabetic or lipid lowering medication • Females who are pregnant, breast feeding or may wish to become pregnant during the study • Abnormal ECG result • Fasting glucose >7.0 mmol/L • Total cholesterol >8.0 mmol/L • Clinically significant out of range values of serum levels of liver, kidney and pancreatic enzymes, to be judged by the study physician • Anaemia, Hb-level 25 kg/m2 • Reported alcohol consumption > 14 units/week (female) or > 21 units/week (male) • History of illicit drug use • Reported weight loss or gain of 3 kg or more during a period of 2 months prior to screening • Active blood donor (

Design outcomes

Primary

MeasureTime frame
The primary study parameter is energy metabolism in apparently healthy volunteers.

Secondary

MeasureTime frame
Secondary outcome parameters are substrate oxidation, glucose and lipid metabolism, hepatic, kidney and pancreatic function, vascular function, oxidative stress and clinical and inflammatory parameters.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)