Gastro-intestinal and Hormonal Responses to Systemic Inflammatory Disease

NCT04056286 | Completed

• 1 other identifier: Ketone Gastro study
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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).

Conditions

Motility Disorder; Catabolic State; Endotoxemia

Keywords

gastric emptying; gastro-intestinal motility; endotoxemia; catabolism; GLP-1; GIP

Outcome Measures

Primary Outcomes (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 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)

• Difference in gastric emptying (healthy vs catabolic conditions)

  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)

  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)

  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)

  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)

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

Study Arms (3)

Healthy + Whey

EXPERIMENTAL

Healthy (overnight fast)

Dietary Supplement: Whey

Catabolic + Whey

EXPERIMENTAL

Catabolic (Inflammation (LPS) + 36 hour fast and bed rest)

Dietary Supplement: Whey

Catabolic + 3-OHB / Whey

EXPERIMENTAL

Catabolic (Inflammation (LPS) + 36 hour fast and bed rest)

Dietary Supplement: 3-OHB/whey

Interventions

Whey DIETARY_SUPPLEMENT

45 g whey protein + 20 g maltodextrin

Catabolic + Whey; Healthy + Whey

3-OHB/whey DIETARY_SUPPLEMENT

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

Catabolic + 3-OHB / Whey

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• Arla Food Ingrediens: collaborator
• Aarhus University Hospital: collaborator

Study Sites (1)

Medical Reasearch labaratory, DoH, Aarhus University Hospital

Aarhus N, Danmark, 8200, Denmark

Location

MeSH Terms

Conditions

Endotoxemia

Interventions

Whey

Condition Hierarchy (Ancestors)

Bacteremia; Sepsis; Infections; Toxemia; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages

Study Officials

• Niels Moeller, Professor

  Aarhus University Hospital and Institute of Clinical Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: July 29, 2019
• First Posted: August 14, 2019
• Study Start: June 17, 2019
• Primary Completion: January 23, 2020
• Study Completion: January 23, 2020
• Last Updated: June 11, 2020

Record last verified: 2019-07

Locations

DK (1)