An interventional study of Whey and 3-OHB/whey in Motility Disorder, Catabolic State and Endotoxemia, 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
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).
Background: Endotoxemia (LPS) is known to cause fever, inflammation and nausea, but the underlying mechanisms are unknown. In a human disease model comprising LPS-induced inflammation, 36 hour fast and bed rest the investigators want to investigate mechanisms accounting for the nausea and decreased food intake often observed in hospitalized patients.
Aim: This study aims to investigate total transit time and motility of the GI-tract together with the regulation of gut- and appetite hormones following catabolic conditions compared with healthy controlled conditions
Hypothesis:
Catabolic stress (endotoxemia/inflammation + 36 h fast and bed rest) induces GI-tract and hormonal 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-ketone/whey protein
Beverages will be isonitrogenous with 45 g whey protein + 20 g maltodextrin +/- 50 g of 3-OHB. Bolus/sip administration will be applied (1/3 bolus, 2/3 sip).Beverages will be isocaloric (fat will be added to interventions without 3-OHB)
*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.
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:
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 (overnight fast)
Dietary Supplement: Whey
Catabolic (Inflammation (LPS) + 36 hour fast and bed rest)
Dietary Supplement: Whey
Catabolic (Inflammation (LPS) + 36 hour fast and bed rest)
Dietary Supplement: 3-OHB/whey
45 g whey protein + 20 g maltodextrin
50 g 3-OHB + 45 g whey protein + 20 g maltodextrin
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.
Time frame: 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))
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
Time frame: 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)
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
Time frame: 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)
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
Time frame: 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)
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
Time frame: Measured from intake of the Smartpill (t = 210) until excretion with faeces (expected time frame: 2-5 days)
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
Time frame: Measured from intake of the Smartpill (t = 210) until excretion with faeces (expected time frame: 2-5 days)
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
Time frame: Measured from intake of the Smartpill (t = 210) until excretion with faeces (expected time frame: 2-5 days)
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
Time frame: Measured at baseline and 30, 60, 90, 120 and 200 minutes after the beginning of the basal period
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
Time frame: Given at timepoint t = 240 minutes
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
Time frame: Given at timepoint t = 240 minutes
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Whey Proteins