NCT04056286

Gastro-intestinal and Hormonal Responses to Systemic Inflammatory Disease

Gastro-intestinal and Hormonal Responses to Systemic Inflammatory Disease: A Human Model Comprising Endotoxemia, Fast and Bed Rest.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: University of Aarhus · Academic / Other
• Sex: Male
• Age: 20 Years – 40 Years
• Healthy volunteers: Accepted

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).

Detailed 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.

Conditions

• Motility Disorder
• Catabolic State
• Endotoxemia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Whey	45 g whey protein + 20 g maltodextrin
DIETARY_SUPPLEMENT	3-OHB/whey	50 g 3-OHB + 45 g whey protein + 20 g maltodextrin

Timeline

• Start date: 2019-06-17
• Primary completion: 2020-01-23
• Completion: 2020-01-23
• First posted: 2019-08-14
• Last updated: 2020-06-11

Locations

1 site across 1 country: Denmark