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Motility DisorderNCT04056286

Gastro-intestinal and Hormonal Responses to Systemic Inflammatory Disease

A study testing Whey and 3-OHB/whey in people with Motility Disorder and Catabolic State, run by University of Aarhus at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 to 40 years, men onlyHealthy volunteers can take part
Conditions the study is for
Motility Disorder, Catabolic State, Endotoxemia
What is being tested?
Whey and 3-OHB/whey
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteDenmark
Study dates
17 Jun 2019to 23 Jan 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 40 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Medical Reasearch labaratory, DoH, Aarhus University Hospital

    Aarhus N, Danmark, 8200

Other trials in Denmark

About this study

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

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).

Read the 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:

  1. 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.

Being tested
Whey, 3-OHB/whey
Keywords
gastric emptying, gastro-intestinal motility, endotoxemia, catabolism, GLP-1, GIP
Medical subject headings
Endotoxemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • WheyDietary supplement

    45 g whey protein + 20 g maltodextrin

  • 3-OHB/wheyDietary supplement

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

Study groups in NCT04056286
Study groupRoleWhat they receive
Healthy + WheyExperimentalHealthy (overnight fast)
Receives: Dietary Supplement: Whey
Catabolic + WheyExperimentalCatabolic (Inflammation (LPS) + 36 hour fast and bed rest)
Receives: Dietary Supplement: Whey
Catabolic + 3-OHB / WheyExperimentalCatabolic (Inflammation (LPS) + 36 hour fast and bed rest)
Receives: Dietary Supplement: 3-OHB/whey

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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: 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 outcomes (9)

  1. 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: 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)

  2. 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: 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)

  3. 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: 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)

  4. 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: Measured from intake of the Smartpill (t = 210) until excretion with faeces (expected time frame: 2-5 days)

  5. 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: Measured from intake of the Smartpill (t = 210) until excretion with faeces (expected time frame: 2-5 days)

  6. 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: Measured from intake of the Smartpill (t = 210) until excretion with faeces (expected time frame: 2-5 days)

  7. 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: Measured at baseline and 30, 60, 90, 120 and 200 minutes after the beginning of the basal period

  8. 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

    Measured: Given at timepoint t = 240 minutes

  9. 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

    Measured: Given at timepoint t = 240 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2019
  2. Study start17 Jun 2019
  3. Primary completion23 Jan 2020
  4. Study completion23 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
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 blind
Who is masked
Outcomes assessor
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04056286
Sponsor's protocol ID
Ketone Gastro study
Status last verified
Jul 2019
First submitted
29 Jul 2019
Last updated
11 Jun 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Whey and 3-OHB/whey in people with Motility Disorder and Catabolic State, run by University of Aarhus at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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))). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04056286.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2020.

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