An interventional study of Whey and 3-OHB + Whey in Cardiac Output, Endotoxemia and Catabolic State, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to male participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-11.
Sponsored by University of Aarhus · Not applicable, Interventional, and Basic science
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).
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:
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)
81 studies on the registry are indexed under Endotoxemia; 7 are open to participants now.
This study's enrollment of 8 is below the median of 31 across 70 interventional studies indexed under Endotoxemia.
Browse Endotoxemia studies →University of Aarhus is the lead sponsor of 1,300 studies on the registry; 189 are open to participants now.
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Exclusion Criteria:
Former major abdominal surgery (Or current problems with the GI tract)
•>10 hours of exercise/weak
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Healthy conditions (overnight fast)
Dietary Supplement: Whey
Catabolic conditions (36-hour fast, bed rest and inflammation (LPS))
Dietary Supplement: Whey
Catabolic conditions (36-hour fast, bed rest and inflammation (LPS))
Dietary Supplement: 3-OHB + Whey
45 g whey + 20 g maltodextrin
50 g ketone + 45 g whey + 20 g maltodextrin
Change in left ventricular outflow tract velocity time integral
Echocardiographic changes in left ventricular outflow tract velocity time integral from the basal period and after 1.5 hours of intervention
Time frame: Measured during the basal period and after 1.5 hours of intervention
Changes in Left Ventricular Ejection Fraction (LVEF)
Echocardiographic changes in LVEF from the basal period and after 1.5 hours of intervention
Time frame: Measured during the basal period and after 1.5 hours of intervention
Changes in Global Longitudinal Strain (GLS)
Echocardiographic changes in GLS from the basal period and after 1.5 hours of intervention
Time frame: Measured during the basal period and after 1.5 hours of intervention
Changes in S´ Max
Echocardiographic changes in S´ Max from the basal period and after 1.5 hours of intervention
Time frame: Measured during the basal period and after 1.5 hours of intervention
Changes in blood pressure
Changes in blood pressure from the basal period and after 1.5 hours of intervention
Time frame: Measured during the basal period and after 1.5 hours of intervention
Changes in heart rate
Changes in heart rate from the basal period and after 1.5 hours of intervention
Time frame: Measured during the basal period and after 1.5 hours of intervention
Changes in axillary temperature
Changes in axillary temperature from the basal period and after 1.5 hours of intervention
Time frame: Measured during the basal period and after 1.5 hours of intervention
Difference in Left Ventricular Ejection Fraction (LVEF) (Healthy vs catabolic conditions)
Echocardiographic difference in LVEF during the basal period between healthy and catabolic conditions (a pooled mean of the two catabolic days, if there is no difference between the first and second time of LPS exposure)
Time frame: Measured after 2 hours of basal period
Difference in Global Longitudinal Strain (GLS) (Healthy vs catabolic conditions)
Echocardiographic difference in GLS during the basal period between healthy and catabolic conditions (a pooled mean of the two catabolic days, if there is no difference between the first and second time of LPS exposure)
Time frame: Measured after 2 hours of basal period
Difference in S´ Max (Healthy vs catabolic conditions)
Echocardiographic difference in S´ Max during the basal period between healthy and catabolic conditions (a pooled mean of the two catabolic days, if there is no difference between the first and second time of LPS exposure)
Time frame: Measured after 2 hours of basal period
Difference in axillary temperature (healthy vs catabolic)
Difference in axillary temperature after 2 hours basal period between healthy and catabolic conditions (a pooled mean of the two catabolic days, if there is no difference between the first and second time of LPS exposure)
Time frame: Measured after 2 hours of basal period
Difference in heart rate (healthy vs catabolic)
Difference in heart rate after 2 hours basal period between healthy and catabolic conditions (a pooled mean of the two catabolic days, if there is no difference between the first and second time of LPS exposure)
Time frame: Measured after 2 hours of basal period
Difference in blood pressure (healthy vs catabolic)
Difference in blood pressure after 2 hours basal period between healthy and catabolic conditions (a pooled mean of the two catabolic days, if there is no difference between the first and second time of LPS exposure)
Time frame: Measured after 2 hours of basal period
Plan to share: No
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Studies of the drug tested here: Whey Proteins