Muscle Protein SynthesisNCT03319550
Whey vs Casein to Combat Post-inflammatory Protein and Muscle Waste in Acute Disease
A study testing Casein, Whey and Leucine-enriched whey in people with Muscle Protein Synthesis and Endotoxemia, run by University of Aarhus at 1 site in Denmark.
Trial 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. 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
- Muscle Protein Synthesis, Endotoxemia, Nutrition
- What is being tested?
- Casein, Whey and Leucine-enriched whey
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- 7 Dec 2017to 19 Sep 2018
- 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
- Healthy Male
- Age between 20-40
- BMI between 20-30
- Normal health examination and blood samples
- Written informed consent
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Whey vs Casein to Combat Post-inflammatory Protein and Muscle Waste - Combining Endotoxemia, Immobilisation and Fasting in Healthy Young Males in a New Model of Acute Febrile Disease
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).
Read the detailed description
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:
- 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
- Muscle Protein Synthesis, Endotoxemia, Nutrition, Milk Protein, Metabolism, Whey
- Being tested
- Casein, Whey, Leucine-enriched whey
- Keywords
- milk protein, endotoxemia, muscle protein synthesis, whey, casein
- Medical subject headings
- Endotoxemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaseinDietary supplement
see experimental description
WheyDietary supplement
see experimental description
Leucine-enriched wheyDietary supplement
see experimental description
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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 Receives: Dietary Supplement: Leucine-enriched whey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Changes in whole body protein synthesis rates (umol/kg/h), breakdown rates (umol/kg/h), phenylalanine to tyrosine conversion rates (umol/kg/h) and net balance (umol/kg/h)
Measured: Change from baseline to 3.5 hours after intervention
Blood enrichment of essential amino acids
measures of essential amino acids in the blood
Measured: At baseline and every 30 minutes during the intervention period (3.5 hours)
Changes in insulin concentrations
Measures of insulin concentration in blood
Measured: At baseline and every 30 minutes during the intervention period (3.5 hours)
Change in Intracellular signalling in muscle measured by western blotting.
Investigating intracellular activity of muscle metabolism pathways by western blotting.
Measured: Change from baseline and after 2 hours of intervention
Energy expenditure
Using indirect calorimetry for 15 min
Measured: At baseline and after 2.5 hours of intervention
Changes in Glucose, fat and protein oxidation rates
Using indirect calorimetry for 15 min for measuring glucose- (mg/kg/min), fat- (mg/kg/min) and protein oxidation (mg/kg/min)
Measured: At baseline and after 2.5 hours of intervention
Change in muscle breakdown and synthesis rates measured by phenylalanine tracer
changes from baseline to 3.5 hours after intervention in Ra(phe)=breakdown (umol/kg/h) and Rd(phe)=synthesis rate (umol/kg/h)
Measured: Change from baseline to 3.5 hours after intervention
Changes in Glucagon concentrations
Glucagon concentrations in blood
Measured: Change from baseline and to 1 hour and 3.5 hour after the intervention
Changes in GIP concentrations
GIP concentrations in blood
Measured: Change from baseline and to 1 hour and 3.5 hour after the intervention
Changes in GLP-1 concentrations
GLP-1 concentrations in blood
Measured: Change from baseline and to 1 hour and 3.5 hour after the intervention
Changes in Glucose concentrations
Glucose concentrations in blood
Measured: At baseline and every 30 minutes during the intervention period (3.5 hours)
Changes in heart rate profile upon repeated LPS exposure
heart rate (beats/min)
Measured: Measured at baseline and 1,2,3,4,5,6 and 24 hours after LPS (6-8 weeks between visit 1,2 and 3)
Changes in temperature profile upon repeated LPS exposure
Axillary temperature (celcius)
Measured: Measured at baseline and 1,2,3,4,5,6 and 24 hours after LPS (6-8 weeks between visit 1,2 and 3)
Changes in blood pressure profile upon repeated LPS exposure
blood pressure (mmHg)
Measured: Measured at baseline and 1,2,3,4,5,6 and 24 hours after LPS (6-8 weeks between visit 1,2 and 3)
Changes in symptom score profile upon repeated LPS exposure
symptom score (from 0-5) for nausea, back pain, muscle pain, headache and chills. 0=no symptoms, 5=severe symptoms.
Measured: Measured at baseline and 1,2,3,4,5,6 and 24 hours after LPS (6-8 weeks between visit 1,2 and 3)
Changes in TNfalfa profile upon repeated LPS exposure
TNfalfa blood concentrations
Measured: Measured at baseline and 1, 2, 4, 6 and 24 hours after LPS (6-8 weeks between visit 1,2 and 3)
Changes in IL-1 profile upon repeated LPS exposure
IL-1 blood concentrations
Measured: Measured at baseline and 1, 2, 4, 6 and 24 hours after LPS (6-8 weeks between visit 1,2 and 3)
Changes in IL-6 profile upon repeated LPS exposure
IL-6 blood concentrations
Measured: Measured at baseline and 1, 2, 4, 6 and 24 hours after LPS (6-8 weeks between visit 1,2 and 3)
Changes in IL-10 profile upon repeated LPS exposure
IL-10 blood concentrations
Measured: Measured at baseline and 1, 2, 4, 6 and 24 hours after LPS (6-8 weeks between visit 1,2 and 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2017
- Study start7 Dec 2017
- Primary completion19 Sep 2018
- Study completion19 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Muscle Protein SynthesisStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Arla Foods
- Responsible party
- Sponsor
- Investigators
- Niels Moeller, Professor, Principal investigator, Institute for clinical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03319550
- Sponsor's protocol ID
- theproteinstudy
- Status last verified
- Nov 2018
- First submitted
- 13 Oct 2017
- Last updated
- 25 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will analyse all data ourselves
Publications
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.
PubMed 33693737
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whey vs Casein to Combat Post-inflammatory Protein and Muscle Waste - Combining Endotoxemia, Immobilisation and Fasting in Healthy Young Males in a New Model of Acute Febrile Disease
- ClinicalTrials.gov ID
- NCT03319550
- Acronym / sponsor ID
- theproteinstudy
- Conditions
- Muscle Protein Synthesis, Endotoxemia, Nutrition, Milk Protein, Metabolism, Whey
- Keywords
- milk protein, endotoxemia, muscle protein synthesis, whey, casein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Arla Foods
- Study start
- 7 Dec 2017 (actual)
- Primary completion
- 19 Sep 2018 (actual)
- Study completion
- 19 Sep 2018 (actual)
- First posted
- 24 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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:
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Casein | Experimental | Dietary Supplement: 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. |
| Whey | Experimental | Dietary Supplement: 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 |
| Leucine-enriched whey | Experimental | Dietary Supplement: 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 |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy Male
- Age between 20-40
- BMI between 20-30
- Normal health examination and blood samples
- Written informed consent
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caseinsee experimental description | Dietary supplement | Casein |
| Wheysee experimental description | Dietary supplement | Whey |
| Leucine-enriched wheysee experimental description | Dietary supplement | Leucine-enriched whey |
Primary outcome
Change in muscle phenylalanine netbalance over the forearm muscle
Time frame: Change from baseline to 3.5 hours after intervention
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
19 secondary outcomes
Change in whole body protein metabolism measured by a combination of phenylalanine- and tyrosine tracer
Time frame: Change from baseline to 3.5 hours after intervention
Blood enrichment of essential amino acids
Time frame: At baseline and every 30 minutes during the intervention period (3.5 hours)
Changes in insulin concentrations
Time frame: At baseline and every 30 minutes during the intervention period (3.5 hours)
Change in Intracellular signalling in muscle measured by western blotting.
Time frame: Change from baseline and after 2 hours of intervention
Energy expenditure
Time frame: At baseline and after 2.5 hours of intervention
Changes in Glucose, fat and protein oxidation rates
Time frame: At baseline and after 2.5 hours of intervention
Change in muscle breakdown and synthesis rates measured by phenylalanine tracer
Time frame: Change from baseline to 3.5 hours after intervention
Changes in Glucagon concentrations
Time frame: Change from baseline and to 1 hour and 3.5 hour after the intervention
Changes in GIP concentrations
Time frame: Change from baseline and to 1 hour and 3.5 hour after the intervention
Changes in GLP-1 concentrations
Time frame: Change from baseline and to 1 hour and 3.5 hour after the intervention
Changes in Glucose concentrations
Time frame: At baseline and every 30 minutes during the intervention period (3.5 hours)
Changes in heart rate profile upon repeated LPS exposure
Time frame: Measured at baseline and 1,2,3,4,5,6 and 24 hours after LPS (6-8 weeks between visit 1,2 and 3)
Changes in temperature profile upon repeated LPS exposure
Time frame: Measured at baseline and 1,2,3,4,5,6 and 24 hours after LPS (6-8 weeks between visit 1,2 and 3)
Changes in blood pressure profile upon repeated LPS exposure
Time frame: Measured at baseline and 1,2,3,4,5,6 and 24 hours after LPS (6-8 weeks between visit 1,2 and 3)
Changes in symptom score profile upon repeated LPS exposure
Time frame: Measured at baseline and 1,2,3,4,5,6 and 24 hours after LPS (6-8 weeks between visit 1,2 and 3)
Changes in TNfalfa profile upon repeated LPS exposure
Time frame: Measured at baseline and 1, 2, 4, 6 and 24 hours after LPS (6-8 weeks between visit 1,2 and 3)
Changes in IL-1 profile upon repeated LPS exposure
Time frame: Measured at baseline and 1, 2, 4, 6 and 24 hours after LPS (6-8 weeks between visit 1,2 and 3)
Changes in IL-6 profile upon repeated LPS exposure
Time frame: Measured at baseline and 1, 2, 4, 6 and 24 hours after LPS (6-8 weeks between visit 1,2 and 3)
Changes in IL-10 profile upon repeated LPS exposure
Time frame: Measured at baseline and 1, 2, 4, 6 and 24 hours after LPS (6-8 weeks between visit 1,2 and 3)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2019.
- Derived from this study: PubMed 33693737Mose 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.
- Individual participant dataSharing planned: No. We will analyse all data ourselves
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niels Moeller, Professor principal investigator
Institute for clinical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Casein, Whey and Leucine-enriched whey in people with Muscle Protein Synthesis and Endotoxemia, 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 5 inclusion and 4 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 25 Apr 2019. 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?
Change in muscle phenylalanine netbalance over the forearm muscle (time frame: Change from baseline to 3.5 hours after intervention). 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 NCT03319550, which also lists 1 linked publication.
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 25 Apr 2019.