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Gastro-intestinal and Hormonal Responses to Systemic Inflammatory Disease

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ClinicalTrials.gov Identifier: NCT04056286
Recruitment Status : Recruiting
First Posted : August 14, 2019
Last Update Posted : September 17, 2019
Sponsor:
Collaborators:
Arla Food Ingrediens
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:

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).


Condition or disease Intervention/treatment Phase
Motility Disorder Catabolic State Endotoxemia Dietary Supplement: Whey Dietary Supplement: 3-OHB/whey Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

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

Masking: Single (Outcomes Assessor)
Masking Description: Outcome Assessor will be blinded for all interventions and will recieve raw data sequentially numbered, and will therefore not know which data are from the same test object and which intervention was given.
Primary Purpose: Basic Science
Official Title: Gastro-intestinal and Hormonal Responses to Systemic Inflammatory Disease: A Human Model Comprising Endotoxemia, Fast and Bed Rest.
Actual Study Start Date : June 17, 2019
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : February 1, 2020

Arm Intervention/treatment
Experimental: Healthy + Whey
Healthy (overnight fast)
Dietary Supplement: Whey
45 g whey protein + 20 g maltodextrin

Experimental: Catabolic + Whey
Catabolic (Inflammation (LPS) + 36 hour fast and bed rest)
Dietary Supplement: Whey
45 g whey protein + 20 g maltodextrin

Experimental: Catabolic + 3-OHB / Whey
Catabolic (Inflammation (LPS) + 36 hour fast and bed rest)
Dietary Supplement: 3-OHB/whey
50 g 3-OHB + 45 g whey protein + 20 g maltodextrin




Primary Outcome Measures :
  1. Difference in total gastro-intestinal transit time (healthy vs catabolic conditions) [ 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 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.


Secondary Outcome Measures :
  1. Difference in gastric emptying (healthy vs catabolic conditions) [ 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 gastric emptying by Smartpill between healthy and catabolic conditions. A pooled mean of the two catabolic arms during the basal period will be represented

  2. Difference in small intestine passage time (healthy vs catabolic conditions) [ 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 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

  3. Difference in colon passage time (healthy vs catabolic conditions) [ 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 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

  4. Difference in GI motility (healthy vs catabolic conditions) [ Time Frame: Measured from intake of the Smartpill (t = 210) until excretion with faeces (expected time frame: 2-5 days) ]
    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

  5. Difference in body temperature (healthy vs catabolic conditions) [ Time Frame: Measured from intake of the Smartpill (t = 210) until excretion with faeces (expected time frame: 2-5 days) ]
    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

  6. Difference in pH in the ventricle, small intestine and colon (healthy vs catabolic conditions) [ Time Frame: Measured from intake of the Smartpill (t = 210) until excretion with faeces (expected time frame: 2-5 days) ]
    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

  7. Difference in gastric- and appetite hormones (GLP-1, GIP, PYY and ghrelin) (healthy vs catabolic conditions) [ Time Frame: Measured at baseline and 30, 60, 90, 120 and 200 minutes after the beginning of the basal period ]
    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

  8. Difference in The Gastrointestinal Symptom Rating Scale (GSRS) (healthy vs catabolic conditions) [ Time Frame: Given at timepoint t = 240 minutes ]
    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

  9. Difference in The Pain Catastrophizing Scale (PCS) (healthy vs catabolic conditions) [ Time Frame: Given at timepoint t = 240 minutes ]
    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



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04056286


Contacts
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Contact: Maike Mose, MD 28189854 maikemose@clin.au.dk
Contact: Niels Moeller, Professor 28189854 niels.moeller@clin.au.dk

Locations
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Denmark
Medical Reasearch labaratory, DoH, Aarhus University Hospital Recruiting
Aarhus N, Danmark, Denmark, 8200
Contact: Maike M Mose, MD    004528189854    maikemose@clin.au.dk   
Contact: Niels Moeller, Professor       niels.moeller@clin.au.dk   
Sponsors and Collaborators
University of Aarhus
Arla Food Ingrediens
Aarhus University Hospital
Investigators
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Principal Investigator: Niels Moeller, Professor Aarhus University Hospital and Institute of Clinical Medicine

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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT04056286     History of Changes
Other Study ID Numbers: Ketone Gastro study
First Posted: August 14, 2019    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Aarhus:
gastric emptying
gastro-intestinal motility
endotoxemia
catabolism
GLP-1
GIP
Additional relevant MeSH terms:
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Endotoxemia
Bacteremia
Sepsis
Infection
Toxemia
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes