Endotoxemia Clinical Trial
Official title:
Gastro-intestinal and Hormonal Responses to Systemic Inflammatory Disease: A Human Model Comprising Endotoxemia, Fast and Bed Rest.
The aim of this study is to describe hormonal responses and changes of the gastrointestinal
(GI) tract during healthy and catabolic inflammatory conditions.
Participants will receive isocaloric, isonitrogenous beverages of either whey or 3-OHB+whey
in a randomized crossover design during either healthy (overnight fast) or catabolic
conditions (inflammation/endotoxemia + 36 h fast and bed rest).
Background: Endotoxemia (LPS) is known to cause fever, inflammation and nausea, but the
underlying mechanisms are unknown. In a human disease model comprising LPS-induced
inflammation, 36 hour fast and bed rest the investigators want to investigate mechanisms
accounting for the nausea and decreased food intake often observed in hospitalized patients.
Aim: This study aims to investigate total transit time and motility of the GI-tract together
with the regulation of gut- and appetite hormones following catabolic conditions compared
with healthy controlled conditions
Hypothesis:
Catabolic stress (endotoxemia/inflammation + 36 h fast and bed rest) induces GI-tract and
hormonal changes compared with healthy conditions (overnight fast)
Interventions:
In a randomized crossover design, eight healthy, lean, young men will undergo either:
i) Healthy conditions (overnight fast) + whey protein
ii) Catabolic conditions (Inflammation (LPS) + 36-hour fast and bed rest*) + whey protein
iii) Catabolic conditions (Inflammation (LPS) + 36-hour fast and bed rest*) + 3-ketone/whey
protein
Beverages will be isonitrogenous with 45 g whey protein + 20 g maltodextrin +/- 50 g of
3-OHB. Bolus/sip administration will be applied (1/3 bolus, 2/3 sip).Beverages will be
isocaloric (fat will be added to interventions without 3-OHB)
*LPS will be administered (1 ng/kg) the day prior to the study together with fast and bed
rest. On the study day LPS (0.5 ng/kg) will be injected.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04117802 -
Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome
|
N/A | |
Completed |
NCT02922673 -
The Effects of Acetylsalicylic Acid on Immunoparalysis Following Human Endotoxemia
|
N/A | |
Completed |
NCT01766414 -
In Vivo Effects of C1-esterase Inhibitor on the Innate Immune Response During Human Endotoxemia - VECTOR II
|
Phase 3 | |
Completed |
NCT04130321 -
Demonstration of the Prebiotic-like Effects of Camu-camu Consumption Against Obesity-related Disorders in Humans
|
N/A | |
Completed |
NCT02612480 -
Ticagrelor in Human Endotoxemia Response to Human Endotoxemia
|
N/A | |
Completed |
NCT01474629 -
Probiotic Sport Study
|
N/A | |
Completed |
NCT00246714 -
Pathophysiology and Clinical Relevance of Endotoxin Tolerance in Humans
|
Phase 1 | |
Recruiting |
NCT06147440 -
Different Dietary Patterns
|
N/A | |
Recruiting |
NCT03901807 -
Safety and Efficacy of Polymyxin B Hemoperfusion (PMX) for Endotoxemic Septic Shock in a Randomized, Open-Label Study
|
N/A | |
Completed |
NCT03754504 -
Effects of Cranberry Powder Supplements on Gut Microbiota Diversity and Metabolic Syndrome
|
N/A | |
Completed |
NCT03800277 -
Effect of Cranberry and Agaves Extract on Microbiota and Intestinal Health
|
N/A | |
Completed |
NCT00785018 -
In Vivo Effects of C1-esterase Inhibitor on the Innate Immune Response During Human Endotoxemia
|
N/A | |
Recruiting |
NCT00413465 -
Study of Renal Blood Flow During Human Endotoxemia
|
N/A | |
Recruiting |
NCT00413348 -
Type 2 Diabetes and the Effect of Probiotics
|
N/A | |
Completed |
NCT00412906 -
Study of Gene Activity in Fat and Muscle in Diabetics and Healthy Controls
|
N/A | |
Completed |
NCT05752968 -
Elevated Levels of Antibodies to Endotoxin Core in Hemodialysis Patients With Peripheral Artery Disease
|
||
Completed |
NCT01374711 -
The Effects of Immunostimulation With GM-CSF or IFN-y on Immunoparalysis Following Human Endotoxemia
|
N/A | |
Completed |
NCT00916448 -
The Effects of Atazanavir-induced Hyperbilirubinemia During Human Endotoxemia
|
N/A | |
Completed |
NCT00332267 -
Cerebral Blood Flow and Metabolism During Hypoxia and Endotoxemia
|
N/A | |
Completed |
NCT03482284 -
Effect of Monosaccharides on Intestinal Barrier Function
|
N/A |