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

NCT ID: NCT03319550

Last Updated: 2019-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-07

Study Completion Date

2018-09-19

Brief Summary

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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).

Detailed Description

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Background:

Acute illness is accompanied by infection/inflammation, anorexia and immobilization all contributing to muscle loss, making nutritional supplement optimization an obvious target for investigation and eventually clinical intervention. In the clinical setting large heterogenicity among patients complicates investigations of muscle metabolism during acute illness. Therefore we introduce a disease model by combining "Inflammation + 36 hour fast and bedrest". Inflammation/febrile illness will be initiated by using the well-established "human endotoxemia model" with a bolus injection of Escherichia coli lipopolysaccharide (LPS), known to cause inflammation comparable with the initial phase of sepsis. The amino acid leucine has shown to be particularly anabolic in performance sports, but little is known about its potential beneficial effects during acute illness. Leucine is a powerful activator of muscle protein synthesis and it seems that protein supplements with the highest leucine content elicit a greater increase in protein synthesis than those with a smaller fraction of leucine.

The protein supplements used most in hospitals contain casein derived protein, which has a much lower leucine content than the whey protein compounds typically used in performance sports.

This study compares three different protein supplements.The study is an open, randomized crossover trial. Laboratory technicians, test subjects and investigators will be blinded.

Interventions:

I. LPS (1 ng/kg as bolus) + 36 h fasting + 36 h bedrest + Casein (9% leucine) II. LPS (1 ng/kg as bolus) + 36 h fasting + 36 h bedrest + Whey (11% leucine) III. LPS (1 ng/kg as bolus) + 36 h fasting + 36 h bedrest + Leucine-enriched whey (16% leucine)

The test objects will be given 0,6 g protein/kg, 1/3 as a bolus and 2/3 as sipping over a period of 3,5 hour. Muscle metabolism will be investigated by phenylalanine tracer using the forearm model and total protein metabolism using a carbamide tracer. Through muscle biopsies intracellular signalling pathways will be investigated.

Conditions

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Muscle Protein Synthesis Endotoxemia Nutrition Milk Protein Metabolism Whey Casein

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators
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.

Study Groups

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Casein

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

Group Type EXPERIMENTAL

Casein

Intervention Type DIETARY_SUPPLEMENT

see experimental description

Whey

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

Group Type EXPERIMENTAL

Whey

Intervention Type DIETARY_SUPPLEMENT

see experimental description

Leucine-enriched whey

"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

Group Type EXPERIMENTAL

Leucine-enriched whey

Intervention Type DIETARY_SUPPLEMENT

see experimental description

Interventions

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Casein

see experimental description

Intervention Type DIETARY_SUPPLEMENT

Whey

see experimental description

Intervention Type DIETARY_SUPPLEMENT

Leucine-enriched whey

see experimental description

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Arla Food for Health

UNKNOWN

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Niels Moeller, Professor

Role: PRINCIPAL_INVESTIGATOR

Institute for clinical Medicine

Locations

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Aarhus University Hospital

Aarhus, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 33693737 (View on PubMed)

Other Identifiers

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theproteinstudy

Identifier Type: -

Identifier Source: org_study_id

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