Muscle Loss Clinical Trial
Official title:
Anabolic Potential of Adding 3-hydroxybutyrate (3-OHB) to Whey Protein in a Catabolic Inflammatory Disease Model: A Human Randomized Controlled Trial
Verified date | July 2019 |
Source | University of Aarhus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study aims to investigate the muscle anabolic potential of adding ketone (3-hydroxybutyrate) to whey protein compared with isocaloric, isonitrogenous whey protein in a human model of inflammatory catabolic disease. Further, this study aims to investigate whether the same amount of whey protein has different effects on muscles in an catabolic inflammatory setting compared with a healthy setting.
Status | Completed |
Enrollment | 8 |
Est. completion date | January 23, 2020 |
Est. primary completion date | January 23, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 20 Years to 40 Years |
Eligibility |
Inclusion Criteria: - Between 20-40 years of age - Body mass index between 20-30 kg/m^2 - Healthy - Oral and written consent forms obtained prior to study day Exclusion Criteria: - Recent immobilization of an extremity that is not fully rehabilitated - Lactose, lidocain or rubber allergies - Current disease - Use of anabolic steroids - Smoking - Former major abdominal surgery (Or current problems with the GI tract) - >10 hours of exercise/weak - Present ketogenic diets or high-protein diets - Blood doner that does not want to discontinue blood donations until study completion - Pending MR scan |
Country | Name | City | State |
---|---|---|---|
Denmark | Medical Research Laboratory, DoH, Aarhus University Hospital | Aarhus |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus | Aarhus University Hospital, Arla Foods Ingredients |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in forearm muscle kinetics measured by phenylalanine tracer (Netbalance, rate of disappearence and rate of apperance of phenylanine, nmol/100ml muscle/min) | Changes of forearm muscle phenylalanine kinetics from baseline to 3.5 hours after intervention using the forearm model | Change from baseline to 3.5 hours after intervention | |
Secondary | Change in concentration of total aminoacids | Change in total aminoacids from baseline to the end of the 3.5 hour sipping period | Change from baseline to 3.5 hours after intervention | |
Secondary | Change in concentration of 3-hydroxybutyrate (mmol/L) ) | Change in blood BHB levels from baseline to the end of the 3.5 hour sipping period (iAUC) | Measured at baseline and every 30. min throughout the 3.5 hour sipping period | |
Secondary | Change in glucose kinetics measured by glucose tracer (rate of apperance and rate of disappearance, mg/kg/min) | Change in glucose kinetics from baseline to to the end of the 3.5 hour sipping period | Change from baseline to 3.5 hours after intervention | |
Secondary | Change in concentration of plasma insulin | Change in plasma insulin levels from baseline to the end of the 3.5 hour sipping period (iAUC) | Measured at baseline and every 30. min throughout the 3.5 hour sipping period | |
Secondary | Change in concentration of plasma glucose | Change in glucose levels from baseline and after 3.5 hour sipping period expressed as iAUC. | Measured at baseline and every 30. min throughout the 3.5 hour sipping period | |
Secondary | Change in concentration of free fatty acids (FFA) levels | Change in FFA from baseline to the end of the sipping period | Change from baseline to 3.5 hours after intervention | |
Secondary | Change in concentration of C-reactive peptide (CRP) | Change in CRP from baseline to the end of the sipping period | Change from baseline to 3.5 hours after intervention | |
Secondary | Change in concentration of blood leucocytes (x10^9/L) | Change in leucocytes from baseline to the end of the sipping period | Change from baseline to 3.5 hours after intervention | |
Secondary | Change in concentration of stress hormones (glucagon, cortisol, adrenalin, noradrenalin) | Change in hormones from baseline and after 3.5 hour sipping period | Change from baseline to 3.5 hours after intervention | |
Secondary | Change in intracellular muscle signalling | Change in muscle signalling in muscle biopsies by western blot from baseline to the sipping period | Change from baseline to 3.5 hours after intervention | |
Secondary | Difference in muscle forearm kinetics measured by phenylalanine tracer (Netbalance, rate of apperance, rate og disappearance) (healthy vs catabolic) | Phenylalanine forearm kinetics measured by phenylalanine tracer at the end of the 3.5 hour basal period in healthy vs catabolic (pooled mean of the two catabolic days, if there is no difference between the first and second time of LPS exposure) | measured at the end of the 3.5 hour basal period | |
Secondary | Difference in concentration of total amino acids (healthy vs catabolic) | Total amino acids measured at the end of the 3.5 hour basal period in healthy vs catabolic conditions (pooled mean of the two catabolic days, if there is no difference between the first and second time of LPS exposure) | measured at the end of the 3.5 hour basal period | |
Secondary | Difference in glucose kinetics measured with glucose tracer (mg/kg/min) (healthy vs catabolic) | Glucose kinetics measured by glucose tracer at the end of the 3.5 hour basal period in healthy vs catabolic conditions (pooled mean of the two catabolic days, if there is no difference between the first and second time of LPS exposure) | measured at the end of the 3.5 hour basal period | |
Secondary | Difference in concentration of free fatty acids (FFA) (healthy vs catabolic) | FFA measured at the end of the basal period in healthy vs catabolic (pooled mean of the two catabolic days) | Measured at the end of the 3.5 hour basal period. | |
Secondary | Difference in concentration of C-reactive peptide (CRP) (healthy vs catabolic) | CRP measured at the end of the basal period in healthy vs catabolic (pooled mean of the two catabolic days) | Measured at the end of the 3.5 hour basal period. | |
Secondary | Difference in concentration of leucocytes (healthy vs catabolic) | Leucocytes measured at the end of the basal period in healthy vs catabolic (pooled mean of the two catabolic days) | Measured at the end of the 3.5 hour basal period. | |
Secondary | Difference in intracellular muscle signalling (healthy vs catabolic) | Muscle signalling measured in muscle biopsies by western blot during the 3.5 hour basal period in healthy vs catabolic (pooled mean of the two catabolic days) | Measured at the end of the 3.5 hour basal period. | |
Secondary | Difference in concentration of 3-hydroxybutyrate (mmol/L) (healthy vs catabolic) | 3-hydroxybutyrate measured at the end of the basal period in healthy vs catabolic (pooled mean of the two catabolic days) | Measured at the end of the 3.5 hour basal period. | |
Secondary | Difference in concentration of hormones (insulin, glucagon, cortisol, growth hormone, adrenaline, noradrenalin) (healthy vs catabolic) | Hormones (insulin, glucagon, cortisol, growth hormone, adrenaline, noradrenalin) measured at the end of the basal period in healthy vs catabolic (pooled mean of the two catabolic days) | Measured at the end of the 3.5 hour basal period. | |
Secondary | Difference in whole body protein metabolism (healthy vs catabolic) | Difference in whole body protein metabolism measured with tyrosine tracers at the end of the basal period in healthy vs catabolic (pooled mean of the two catabolic days) | Measured at the end of the 3.5 hour basal period. | |
Secondary | Difference in concentration of cytokines (healthy vs catabolic) | Cytokines (TNFalfa, IL-10, IL-6 and IL-1beta) measured between healthy and catabolic conditions (iAUC, a pooled mean of the two catabolic days, if there is no difference between the first and second time of LPS exposure)) | Measured at baseline and 120 and 240 minutes after LPS administration | |
Secondary | Difference in axillary temperature (healthy vs catabolic) | Change in axillary temperature (iAUC). A pooled mean of the two catabolic days, if there is no difference between the first and second time of LPS exposure. | Measured at baseline and 1, 2, 3, 4, 5, 6 and 7 hours after LPS administration | |
Secondary | Difference in heart rate (healthy vs catabolic) | Change in heart rate (iAUC). A pooled mean of the two catabolic days, if there is no difference between the first and second time of LPS exposure. | Measured at baseline and 1, 2, 3, 4, 5, 6 and 7 hours after LPS administration | |
Secondary | Difference in mean arterial pressure (MAP) (healthy vs catabolic) | Change in MAP (iAUC). A pooled mean of the two catabolic days, if there is no difference between the first and second time of LPS exposure. | Measured at baseline and 1, 2, 3, 4, 5, 6 and 7 hours after LPS administration | |
Secondary | Difference in symptom score (healthy vs catabolic) | Change from baseline and throughout the experiment (iAUC). A pooled mean of the two catabolic days, if there is no difference between the first and second time of LPS exposure. Scale 0-5, 0=no symptoms and 5=severe symptoms | Measured at baseline and 1, 2, 3, 4, 5, 6 and 7 hours after LPS administration |
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