Clinical Trials Directory

Trials / Completed

CompletedNCT04037722

Echocardiographic Changes After 3-hydroxy Butyrate+Whey Intake

Echocardiographic Changes After Oral Intake of 3-hydroxy Butyrate+Whey in a Human Endotoxemia Model

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

This study evaluates the cardiovascular effects of adding the ketone body 3-hydroxy butyrate (3-OHB) to whey protein during human endotoxemia. Further, this study compares cardiovascular changes during healthy and catabolic 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: A newly published study found beneficial cardiovascular effects of 3-OHB infusion in a population with chronic heart failure, significantly increasing cardiac output. Similar effects on cardiac output were observed in healthy volunteers. These findings pave the way for 3-OHB as a therapeutic nutritional supplement, since it is well-absorbed during oral consumption. However, it is unknown whether the cardiovascular effects of 3-OHB persist during a sepsis-like catabolic state and when administered orally. Aim: This study aims to investigate the cardiovascular effects of adding the ketone body 3-hydroxy butyrate (3-OHB) to whey protein during a human disease model, comprising endotoxemia + bed rest + fast. Hypothesis: 1. Adding the ketone body 3-OHB to an oral protein supplement increases cardiac output measures 2. Catabolic stress (endotoxemia/inflammation + 36 h fast and bed rest) induces cardiovascular 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-OHB/whey protein\^" \*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. \^Beverages will be isonitrogenous and isocaloric (fat will be added) with 45 g whey protein + 20 g maltodextrin. Bolus/sip administration will be applied (1/3 bolus, 1/2 sip) " 50 grams of 3-OHB will be orally administered (1/2 bolus, 1/2 sip)

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTWhey45 g whey + 20 g maltodextrin
DIETARY_SUPPLEMENT3-OHB + Whey50 g ketone + 45 g whey + 20 g maltodextrin

Timeline

Start date
2019-06-17
Primary completion
2020-01-23
Completion
2020-01-23
First posted
2019-07-30
Last updated
2020-06-11

Locations

1 site across 1 country: Denmark

Source: ClinicalTrials.gov record NCT04037722. Inclusion in this directory is not an endorsement.