Appetitive Behavior Clinical Trial
Official title:
Acute Exercise and NK Cell Regulation in Tissue and Circulation After IL-6R Blockade - a Randomized Controlled Trial
Verified date | August 2022 |
Source | Rigshospitalet, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study is a randomized controlled trial studying the acute effect of intense aerobic exercise upon NK (Natural Killer) cell activation and appetite-regulation in human participants with or without concommitant IL-6R receptor blockade (Tocilizumab)
Status | Completed |
Enrollment | 30 |
Est. completion date | October 4, 2021 |
Est. primary completion date | October 4, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 40 Years |
Eligibility | Inclusion Criteria: - recreationally active - moderately trained - healthy young males aged 18-40 years - BMI from 18-30 kg·m2 Exclusion Criteria: - Cardiovascular disease - Rheumatologic disease - Metabolic disease, - Elite sports or high aerobically training status (VO2max>60ml O2/min/kg), - Frequent/chronic use of medications affecting physical performance or inflammation (NSAIDS, DMARDS) |
Country | Name | City | State |
---|---|---|---|
Denmark | Center For Physical Activity (CFAS) | Copenhagen Ø |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark |
Denmark,
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* Note: There are 42 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Kinetics and regulation of NK (Natural Killer) cells during and following acute exercise | Change in NK cell and NK cell subset count in circulation before and after acute aerobic exercise with or without IL-6R blockade. | Up to 1 day | |
Primary | NK cell phenotype in response to acute exercise with or without IL-6R blockade | Change in NK-cell phenotype using single cell RNA sequencing. Here, within-group changes of baseline vs. post exercise timepoints as well as between group differences between IL-6 blockade and placebo will be investigated.
The focus will be on markers of cytotoxicity, cell adhesion and adrenergic signaling. |
Up to 1 day | |
Secondary | Change in NK cell count in adipose tissue | Using a combination of histology, western blot and gene-expression analysis for CD56, CD57 and other NK-cell markers, the principal investigator will identify and count the number of NK cells in adipose tissue | 3 hours after intervention | |
Secondary | Change in NK cell phenotype in adipose tissue | Using a combination of histology, western blot and gene-expression analysis for CD56, CD57 and other NK-cell markers, the principal investigator will identify the phenotype of NK cells in adipose tissue | 3 hours after intervention | |
Secondary | Change in NK cell count in muscle tissue | Using a combination of histology, western blot and gene-expression analysis for CD56, CD57 and other NK-cell markers, the principal investigator will identify and count the number of NK cells in muscle tissue | 3 hours after intervention | |
Secondary | Change in NK cell phenotype in muscle tissue | Using a combination of histology, western blot and gene-expression analysis for CD56, CD57 and other NK-cell markers, the principal investigator will identify the phenotype of NK cells in muscle tissue | 3 hours after intervention | |
Secondary | Change in macrophage count in muscle tissue | Using a combination of histology, western blot and gene-expression analysis for CD68, CD163, CD206, TNF-alpha and other macrophage markers, the principal investigator will identify and count the number of macrophages in muscle tissue | 3 hours after intervention | |
Secondary | Change in macrophage phenotype in muscle tissue | Using a combination of histology, western blot and gene-expression analysis for CD68, CD163, CD206, TNF-alpha and other macrophage markers, the principal investigator will phenotype (M1/M2) macrophages in muscle tissue | 3 hours after intervention | |
Secondary | Change in macrophage count in adipose tissue | Using a combination of histology, western blot and gene-expression analysis for CD68, CD163, CD206, TNF-alpha and other macrophage markers, the principal investigator will identify and count the number of macrophages in adipose tissue | 3 hours after intervention | |
Secondary | Change in macrophage phenotype in adipose tissue | Using a combination of histology, western blot and gene-expression analysis for CD68, CD163, CD206, TNF-alpha and other macrophage markers, the principal investigator will phenotype (M1/M2) macrophages in adipose tissue | 3 hours after intervention | |
Secondary | Change in T-cell count in adipose tissue | Using a combination of histology, western blot and gene-expression analysis for CD3, CD8, and other T-cell markers, the principal investigator will count the number of T-cells in adipose tissue | 3 hours after intervention | |
Secondary | Change in T-cell phenotype in adipose tissue | Using a combination of histology, western blot and gene-expression analysis for CD3, CD8, and other T-cell markers, the principal investigator will phenotype the T-cells in adipose (CD3+/CD8+) tissue | 3 hours after intervention | |
Secondary | Change in T-cell count in muscle tissue | Using a combination of histology, western blot and gene-expression analysis for CD3, CD8, and other T-cell markers, the principal investigator will count the number of T-cells in muscle tissue | 3 hours after intervention | |
Secondary | Change in T-cell phenotype in muscle tissue | Using a combination of histology, western blot and gene-expression analysis for CD3, CD8, and other T-cell markers, the principal investigator will phenotype (CD3+/CD8+) the T-cells in muscle tissue | 3 hours after intervention | |
Secondary | Change in monocyte count in circulation | Using flow cytometry we will identify and count monocytes in circulation | Up to 1 day | |
Secondary | Change in T-cell count in circulation | Using flow cytometry the investigators will count T-cells in circulation | Up to 1 day | |
Secondary | Change in B-cell count in circulation | Using flow cytometry the investigators will count B-cells in circulation | Up to 1 day | |
Secondary | Change in IL-6 receptor expression on NK-cells in circulation | The change in IL-6 receptor surface expression on circulating NK-cells using flow cytometry | Up to 1 day | |
Secondary | Change in circulating IL-6 | Plasma IL-6 conc. using ELISA assay | Up to 1 day | |
Secondary | Change in circulating IL-2 | Plasma IL-2 conc. using ELISA assay | Up to 1 day | |
Secondary | Change in circulating IL-1 | Plasma IL-1 conc. using ELISA assay | Up to 1 day | |
Secondary | Change in circulating IL-10 | Plasma IL-10 conc. using ELISA assay | Up to 1 day | |
Secondary | Change in circulating TNF-alpha | Plasma TNF-alpha conc.using ELISA assay | Up to 1 day | |
Secondary | Change in circulating G-CSF | Plasma TNF-alpha conc. using ELISA assay | Up to 1 day | |
Secondary | Change in circulating epinephrine | Blood epinephrine conc. using ELISA assay | Up to 1 day | |
Secondary | Change in circulating norepinephrine | Blood norepinephrine conc. using ELISA assay | Up to 1 day | |
Secondary | Change in circulating total leucocytes | Blood leucocyte count using sysmex XN | Up to 1 day | |
Secondary | Change in circulating neutrophils | Blood neutrophil count.using sysmex XN | Up to 1 day | |
Secondary | Change in circulating reticulocytes | Blood reticulocytes count.using sysmex XN | Up to 1 day | |
Secondary | Change in circulating eosinophils | Blood eosinophil count.using sysmex XN | Up to 1 day | |
Secondary | Change in circulating basofile leucocytes | Blood basofile leucocytes count.using sysmex XN | Up to 1 day | |
Secondary | Change in circulating total lymphocytes | Blood lymphocyte count.using sysmex XN | Up to 1 day | |
Secondary | Change in circulating Prolactin | Plasma Prolactin conc. using sysmex XN | Up to 1 day | |
Secondary | Change in cortisol | Plasma cortisol conc. using sysmex XN | Up to 1 day | |
Secondary | Change in metamyelocytes | Blood metamyelocyte count using sysmex XN | Up to 1 day | |
Secondary | Change in ACTH | Plasma ACTH conc. using sysmex XN | Up to 1 day | |
Secondary | Change in circulating lactate | Blood lactate using ABL | Up to 1 day | |
Secondary | Change in CRP | Plasma CRP conc. using sysmex XN | Up to 1 day | |
Secondary | Change in hsCRP | Plasma CRP conc. using ELISA | Up to 1 day | |
Secondary | Novel myokines during acute exercise | As an explorative outcome the investigators will investigate possible novel signal molecules released during exercise with immunological importance, either in circulation or in tissue (i.e. GDNF [Glial cell Derived Neurotrophic Factor]) | Immediately after acute bout of exercise | |
Secondary | VO2max | VO2max using bicycle ergometer and Oxicon Online system | Baseline | |
Secondary | Lean Body mass | Lean body mass using dual-energy x-ray absorptiometry (DXA) | Baseline | |
Secondary | Fat mass | Fat mass using dual-energy x-ray absorptiometry (DXA) | Baseline | |
Secondary | Bone Mineral Density | Bone Mineral Density using dual-energy x-ray absorptiometry (DXA) | Baseline | |
Secondary | Appetite assessment | Hunger, satiety, fullness, and prospective food consumption will be rated using a visual analog scales (VAS). A line of 20 cm is drawn from left to right on A4 paper starting at 0 cm with " not hungry at all" ending at 20 cm with "never been more hungry in my life". The subject mark somewhere in between according to his subjective feeling, The length is reported and indicates the degree of hunger, eg. the longer the line the more hunger. In general the longer to right the person marks the line, the stronger is the subjective felling within the given question | 4 hours after intervention | |
Secondary | Ad libitum caloric intake | Caloric intake will be determined by providing meal consisting of a hot pot of homogeneous pasta Bolognese (1,440 g, 1,912 kcal, 55 E percent carbohydrate, 30 E percent fat, 15 E percent protein; homogeneous composition) served with a glass of water of 150 ml 1 h after exercise. Participants will sit quietly on their own and are asked to eat until comfortably full/satiated and to drink all of the water. The duration of the meal is sat to 30 minutes | 4 hours after intervention | |
Secondary | Gastric emptying | Gastric emptying will be assessed by the participants drinking 100 ml in which 1,5 g paracetamol is dissolved. The Paracetamol concentration will be determined by Sandwich Electro-Chemiluminescence-Immunoassay (ECLIA) | 4 hours after intervention | |
Secondary | Change in GLP1 | Plasma GLP1 conc. using ELISA assay | 4 hours after intervention | |
Secondary | Change in PYY | Plasma PYY conc. using ELISA assay | 4 hours after intervention | |
Secondary | Change in CCK | Plasma CCK conc. using ELISA assay | 4 hours after intervention | |
Secondary | Change in Glucose | Plasma Glucose conc. using using sysmex XN | 4 hours after intervention | |
Secondary | Change in Insulin | Plasma insulin conc. using using sysmex XN | 4 hours after intervention | |
Secondary | Change in C-peptide | Plasma C-peptide conc. using using sysmex XN | 4 hours after intervention | |
Secondary | Change in free fatty acids | Plasma free fatty acids conc. using sysmex XN | 4 hours after intervention | |
Secondary | Change in acetoacetate | Plasma acetoacetate conc. using mass spectrometry | 4 hours after intervention | |
Secondary | Change in betahydroxybutyrate | Plasma betahydroxybutyrate conc. using mass spectrometry | 4 hours after intervention | |
Secondary | Change in CRH | Plasma CRH conc. using ELISA | 4 hours after intervention | |
Secondary | Change in AVP | Plasma AVP conc. using ELISA | 4 hours after intervention |
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