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Completed

NCT Number: NCT04056286

Gastro-intestinal and Hormonal Responses to Systemic Inflammatory Disease

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).

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Key information

Conditions

Motility Disorder Bacteremia Catabolic State Endotoxemia Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome Toxemia

Age range

20 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Medical Reasearch labaratory, DoH, Aarhus University Hospital

Aarhus N, Danmark, 8200, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Whey

Dietary Supplement

45 g whey protein + 20 g maltodextrin

3-OHB/whey

Dietary Supplement

50 g 3-OHB + 45 g whey protein + 20 g maltodextrin

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital
  • Arla Foods

Registry information

Official study title

Gastro-intestinal and Hormonal Responses to Systemic Inflammatory Disease: A Human Model Comprising Endotoxemia, Fast and Bed Rest.

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 14, 2019
Registry last updated
Jun 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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