Anabolic Potential of 3-hydroxybutyrate (3-OHB) and Whey Protein in a Human Catabolic Inflammatory Disease Model

NCT04064268 | Completed

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

Brief Summary

This study aims to investigate the muscle anabolic potential of adding ketone (3-hydroxybutyrate) to whey protein compared with isocaloric, isonitrogenous whey protein in a human model of inflammatory catabolic disease. Further, this study aims to investigate whether the same amount of whey protein has different effects on muscles in an catabolic inflammatory setting compared with a healthy setting.

Conditions

Endotoxemia; Muscle Loss; Catabolic State; Protein; Disease; Nutrition Therapy

Keywords

endotoxemia; muscle loss; catabolic state; whey protein; 3-hydroxy butyrate

Outcome Measures

Primary Outcomes (1)

• Change in forearm muscle kinetics measured by phenylalanine tracer (Netbalance, rate of disappearence and rate of apperance of phenylanine, nmol/100ml muscle/min)

  Changes of forearm muscle phenylalanine kinetics from baseline to 3.5 hours after intervention using the forearm model

  Change from baseline to 3.5 hours after intervention

Secondary Outcomes (25)

• Change in concentration of total aminoacids

  Change from baseline to 3.5 hours after intervention

• Change in concentration of 3-hydroxybutyrate (mmol/L) )

  Measured at baseline and every 30. min throughout the 3.5 hour sipping period

• Change in glucose kinetics measured by glucose tracer (rate of apperance and rate of disappearance, mg/kg/min)

  Change from baseline to 3.5 hours after intervention

• Change in concentration of plasma insulin

  Measured at baseline and every 30. min throughout the 3.5 hour sipping period

• Change in concentration of plasma glucose

  Measured at baseline and every 30. min throughout the 3.5 hour sipping period

Study Arms (3)

Healthy + Whey

EXPERIMENTAL

Healthy conditions (overnight fast)

Dietary Supplement: Whey

Catabolic + Whey

EXPERIMENTAL

Catabolic conditions (36-hour fast, bed rest and inflammation (LPS))

Dietary Supplement: Whey

Catabolic + 3-OHB / Whey

EXPERIMENTAL

Catabolic conditions (36-hour fast, bed rest and inflammation (LPS))

Dietary Supplement: 3-OHB + Whey

Interventions

Whey DIETARY_SUPPLEMENT

45 g whey + 20 g maltodextrin

Catabolic + Whey; Healthy + Whey

3-OHB + Whey DIETARY_SUPPLEMENT

50 g ketone + 45 g whey + 20 g maltodextrin

Catabolic + 3-OHB / Whey

Eligibility Criteria

• Age: 20 Years - 40 Years
• 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 Foods Ingredients: collaborator
• Aarhus University Hospital: collaborator

Study Sites (1)

Medical Research Laboratory, DoH, Aarhus University Hospital

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Endotoxemia; Muscular Atrophy; Disease

Interventions

Whey

Condition Hierarchy (Ancestors)

Bacteremia; Sepsis; Infections; Toxemia; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• 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 11, 2019
• First Posted: August 21, 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)