Whey vs Casein to Combat Post-inflammatory Protein and Muscle Waste in Acute Disease

NCT03319550 | Completed DMC

• 1 other identifier: theproteinstudy
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study compares three different protein supplements (casein, whey and leucine-enriched whey) and their effect on post-inflammatory muscle waste in a model of acute disease. Each test person will undergo all three interventions. It is believed that leucine is the primary driver of muscle protein synthesis and therefore we hypothesize that leucine-enriched whey and whey are superior to casein in combating post-inflammatory muscle waste, because of its higher leucine content (16%, 11% and 9% leucine, respectively).

Conditions

Muscle Protein Synthesis; Endotoxemia; Nutrition; Milk Protein; Metabolism; Whey; Casein

Keywords

milk protein, endotoxemia, muscle protein synthesis, whey, casein

Outcome Measures

Primary Outcomes (1)

• Change in muscle phenylalanine netbalance over the forearm muscle

  Changes of muscle phenylalanine net balance (= arterio(phe conc)-venous(phe conc) x flow) from baseline to 3.5 hours after intervention using the forearm model

  Change from baseline to 3.5 hours after intervention

Secondary Outcomes (19)

• Change in whole body protein metabolism measured by a combination of phenylalanine- and tyrosine tracer

  Change from baseline to 3.5 hours after intervention

• Blood enrichment of essential amino acids

  At baseline and every 30 minutes during the intervention period (3.5 hours)

• Changes in insulin concentrations

  At baseline and every 30 minutes during the intervention period (3.5 hours)

• Change in Intracellular signalling in muscle measured by western blotting.

  Change from baseline and after 2 hours of intervention

• Energy expenditure

  At baseline and after 2.5 hours of intervention

Study Arms (3)

Casein

EXPERIMENTAL

"LPS + 36 hour fast and bedrest" + Casein (9% leucine) - 0.6 g protein/kg bodyweight, 1/3 as bolus and 2/3 as sipping.

Dietary Supplement: Casein

Whey

EXPERIMENTAL

"LPS + 36 hour fast and bedrest" + Whey (11% leucine) - 0.6 g protein/kg bodyweight, 1/3 as bolus and 2/3 as sipping

Dietary Supplement: Whey

Leucine-enriched whey

EXPERIMENTAL

"LPS + 36 hour fast and bedrest" + Leucine-enriched whey (16% leucine) - 0.6 g protein/kg bodyweight, 1/3 as bolus and 2/3 as sipping

Dietary Supplement: Leucine-enriched whey

Interventions

Casein DIETARY_SUPPLEMENT

see experimental description

Casein

Whey DIETARY_SUPPLEMENT

see experimental description

Whey

Leucine-enriched whey DIETARY_SUPPLEMENT

see experimental description

Leucine-enriched whey

Eligibility Criteria

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

You may qualify if:

• Healthy Male
• Age between 20-40
• BMI between 20-30
• Normal health examination and blood samples
• Written informed consent

You may not qualify if:

• Immobilisation of an extremity, unless a doctor has declared it fully rehabilitated.
• Allergy against lidocain or latex.
• The use of anabolic steroids
• Disease like: Diabetes, epilepsia, infection, cardiovascular disease.

Sponsors & Collaborators

• University of Aarhus: lead
• Arla Food for Health: collaborator

Study Sites (1)

Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Related Publications (1)

• Mose M, Moller N, Jessen N, Mikkelsen UR, Christensen B, Rakvaag E, Hartmann B, Holst JJ, Jorgensen JOL, Rittig N. beta-Lactoglobulin Is Insulinotropic Compared with Casein and Whey Protein Ingestion during Catabolic Conditions in Men in a Double-Blinded Randomized Crossover Trial. J Nutr. 2021 Jun 1;151(6):1462-1472. doi: 10.1093/jn/nxab010.

  PMID: 33693737 DERIVED

MeSH Terms

Conditions

Endotoxemia

Interventions

Caseins; Whey

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Proteins; Amino Acids, Peptides, and Proteins; Phosphoproteins; Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages

Study Officials

• Niels Moeller, Professor

  Institute for clinical Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The three different protein supplements will be fabricated with the same taste, colour and weight. They will be named "A", "B" and "C" and the investigator will not know which protein is which until all data has been collected and analysed.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Interventions\*: I. LPS (1 ng/kg as bolus) + 36 h fasting + 36 h bedrest + Casein II. LPS (1 ng/kg as bolus) + 36 h fasting + 36 h bedrest + Whey III. LPS (1 ng/kg as bolus) + 36 h fasting + 36 h bedrest + Leucine-enriched whey \* LPS will be administered on study day 1 and measurements of metabolism will be performed on study day 2 where we see the secondary effects of acute inflammation. The patient will stay at the hospital over night to ensure continues fast and bedrest. The beverages will be isocaloric and with the same total protein content. The basal period will be 2,5 hour with infusion of tracer. Hereafter a total amount of 0,6 g protein/kg bodyweight will be orally administered, 1/3 as a bolus and 2/3 as sipping over 3,5 hours. Muscle biopsies and blodsampels will be collected during both the basal and the sipping period.

Study Record Dates

• First Submitted: October 13, 2017
• First Posted: October 24, 2017
• Study Start: December 7, 2017
• Primary Completion: September 19, 2018
• Study Completion: September 19, 2018
• Last Updated: April 25, 2019

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)