Clinical Trials Logo

Clinical Trial Summary

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).


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04056286
Study type Interventional
Source University of Aarhus
Contact
Status Completed
Phase N/A
Start date June 17, 2019
Completion date January 23, 2020

See also
  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