Endotoxemia Clinical Trial
Official title:
Gastro-intestinal and Hormonal Responses to Systemic Inflammatory Disease: A Human Model Comprising Endotoxemia, Fast and Bed Rest.
Verified date | July 2019 |
Source | University of Aarhus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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 Reasearch labaratory, DoH, Aarhus University Hospital | Aarhus N | Danmark |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus | Aarhus University Hospital, Arla Food Ingrediens |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference in total gastro-intestinal transit time (healthy vs catabolic conditions) | Difference in total gastro-intestinal transit time measured by the Smartpill system between healthy and catabolic conditions. A pooled mean of the catabolic conditions will be used, if there is no difference between first and second exposure to LPS or "catabolic + whey" and "catabolic + 3-OHB/whey" interventions. | Measured from intake of the Smartpill (together with the bolus of the protein beverages at t=210) until excretion with faeces (expected time frame: 2-5 days)) | |
Secondary | Difference in gastric emptying (healthy vs catabolic conditions) | Difference in gastric emptying by Smartpill between healthy and catabolic conditions. A pooled mean of the two catabolic arms during the basal period will be represented | Measured from intake of the Smartpill (t = 210) until it leaves the ventricle (assessed by rise in pH levels, expected time frame: 2-7 hours) | |
Secondary | Difference in small intestine passage time (healthy vs catabolic conditions) | Difference in small intestine passage time by Smartpill between healthy and catabolic conditions. A pooled mean of the two catabolic arms during the basal period will be represented | Measured from the timepoint where Smartpill leaves the ventricle until it enters the colon (assessed by specific predefined motility and pH patterns, expected timeframe 1-3 days) | |
Secondary | Difference in colon passage time (healthy vs catabolic conditions) | Difference in colon passage time by Smartpill between healthy and catabolic conditions. A pooled mean of the two catabolic arms during the basal period will be represented | Measured from the timepoint where Smartpill leaves the small intestine until it is excreted with faeces (assessed by specific predefined motility and pH patterns, expected timeframe 1-3 days) | |
Secondary | Difference in GI motility (healthy vs catabolic conditions) | Difference in GI motility measured by Smartpill pressure sensor between healthy and catabolic conditions. A pooled mean of the catabolic conditions will be used, if there is no difference between first and second exposure to LPS or "catabolic + whey" and "catabolic + 3-OHB/whey" interventions. A pooled mean of the two catabolic arms during the basal period will be represented | Measured from intake of the Smartpill (t = 210) until excretion with faeces (expected time frame: 2-5 days) | |
Secondary | Difference in body temperature (healthy vs catabolic conditions) | Difference in body temperature measured by Smartpill between healthy and catabolic conditions. A pooled mean of the two catabolic arms during the basal period will be represented | Measured from intake of the Smartpill (t = 210) until excretion with faeces (expected time frame: 2-5 days) | |
Secondary | Difference in pH in the ventricle, small intestine and colon (healthy vs catabolic conditions) | Difference in pH measured by Smartpill between healthy and catabolic conditions in the ventricle, small intestine and colon . A pooled mean of the catabolic conditions will be used, if there is no difference between first and second exposure to LPS or "catabolic + whey" and "catabolic + 3-OHB/whey" interventions. A pooled mean of the two catabolic arms during the basal period will be represented | Measured from intake of the Smartpill (t = 210) until excretion with faeces (expected time frame: 2-5 days) | |
Secondary | Difference in gastric- and appetite hormones (GLP-1, GIP, PYY and ghrelin) (healthy vs catabolic conditions) | Difference in hormones at baseline and throughout the basal period between healthy and catabolic conditions. A pooled mean of the two catabolic arms during the basal period will be represented | Measured at baseline and 30, 60, 90, 120 and 200 minutes after the beginning of the basal period | |
Secondary | Difference in The Gastrointestinal Symptom Rating Scale (GSRS) (healthy vs catabolic conditions) | Written assesment of various symptoms from the GI tract by a score from 0-6 (0 = no symptoms, 6 = very severe symptoms). A pooled mean of the two catabolic arms during the basal period will be represented | Given at timepoint t = 240 minutes | |
Secondary | Difference in The Pain Catastrophizing Scale (PCS) (healthy vs catabolic conditions) | Written assesment of pain-coping (score from 0-6 on each question, 0 = no worries, 6 = severe worrying). A pooled mean of the two catabolic arms during the basal period will be represented | Given at timepoint t = 240 minutes |
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