EndotoxemiaNCT04064268
Anabolic Potential of 3-hydroxybutyrate (3-OHB) and Whey Protein in a Human Catabolic Inflammatory Disease Model
A study testing Whey and 3-OHB + Whey in people with Endotoxemia and Muscle Loss, run by University of Aarhus at 1 site in Denmark.
Trial 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. 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
- Endotoxemia, Muscle Loss, Catabolic State
- What is being tested?
- Whey and 3-OHB + Whey
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteDenmark
- Study dates
- 17 Jun 2019to 23 Jan 2020
- 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
- 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
Who cannot join
- 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)
Show all 10Show fewer
- >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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Medical Research Laboratory, DoH, Aarhus University Hospital
Aarhus, 8000
About this study
Official title: Anabolic Potential of Adding 3-hydroxybutyrate (3-OHB) to Whey Protein in a Catabolic Inflammatory Disease Model: A Human Randomized Controlled Trial
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.
Read the detailed description
Background: Muscle wasting during hospitalization is caused by a combination of immobilization (bed rest), hypocaloric diet and inflammation (e.g. sepsis), and preventive measures are needed. Whey protein is particularly potent in inducing muscle protein synthesis compared with other proteins, at least in healthy populations. Further, the ketone body 3-hydroxybutyrate (3-OHB) effectively preserved muscle in a model of acute inflammatory disease. However, little is known about whether 3-OHB can potentiate the effects of whey protein in a catabolic inflammatory setting.
Aim: This study aims to investigate the muscle anabolic potential of adding ketone (3-OHB) to whey protein compared with isocaloric, isonitrogenous whey protein in a human model of catabolic inflammatory 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.
Hypothesis:
- 3-OHB potentiates the effect of whey protein in maintaining muscle mass in a catabolic inflammatory setting.
- The same amount of whey protein will have decreased muscle anabolic effects during catabolic inflammatory conditions compared with healthy conditions Interventions: In a randomized crossover design, eight healthy, lean, young men will undergo either:
- 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^" *LPS will be administered (1 ng/kg) the day prior to the study together with fast and bed rest. On the study day LPS (0.5 ng/kg) will be injected. ^Beverages will be isonitrogenous and isocaloric (fat will be added) with 45 g whey protein + 20 g maltodextrin. Bolus/sip administration will be applied (1/3 bolus, 1/2 sip) " 50 grams of 3-OHB will be orally administered (1/2 bolus, 1/2 sip) Before each study day: The participants arrive fasting (only tap water allowed) by taxi on the study days. They have been without febrile disease the week prior to investigation, and have not performed exercise for 24 hours.
- Conditions
- Endotoxemia, Muscle Loss, Catabolic State, Protein; Disease, Nutrition Therapy
- Being tested
- Whey, 3-OHB + Whey
- Keywords
- endotoxemia, muscle loss, catabolic state, whey protein, 3-hydroxy butyrate
- Medical subject headings
- Endotoxemia, Muscular Atrophy, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WheyDietary supplement
45 g whey + 20 g maltodextrin
3-OHB + WheyDietary supplement
50 g ketone + 45 g whey + 20 g maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| Healthy + Whey | Experimental | Healthy conditions (overnight fast) Receives: Dietary Supplement: Whey |
| Catabolic + Whey | Experimental | Catabolic conditions (36-hour fast, bed rest and inflammation (LPS)) Receives: Dietary Supplement: Whey |
| Catabolic + 3-OHB / Whey | Experimental | Catabolic conditions (36-hour fast, bed rest and inflammation (LPS)) Receives: Dietary Supplement: 3-OHB + Whey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from baseline to 3.5 hours after intervention
Secondary outcomes (25)
Change in concentration of total aminoacids
Change in total aminoacids from baseline to the end of the 3.5 hour sipping period
Measured: Change from baseline to 3.5 hours after intervention
Change in concentration of 3-hydroxybutyrate (mmol/L) )
Change in blood BHB levels from baseline to the end of the 3.5 hour sipping period (iAUC)
Measured: 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 in glucose kinetics from baseline to to the end of the 3.5 hour sipping period
Measured: Change from baseline to 3.5 hours after intervention
Change in concentration of plasma insulin
Change in plasma insulin levels from baseline to the end of the 3.5 hour sipping period (iAUC)
Measured: Measured at baseline and every 30. min throughout the 3.5 hour sipping period
Change in concentration of plasma glucose
Change in glucose levels from baseline and after 3.5 hour sipping period expressed as iAUC.
Measured: Measured at baseline and every 30. min throughout the 3.5 hour sipping period
Change in concentration of free fatty acids (FFA) levels
Change in FFA from baseline to the end of the sipping period
Measured: Change from baseline to 3.5 hours after intervention
Change in concentration of C-reactive peptide (CRP)
Change in CRP from baseline to the end of the sipping period
Measured: Change from baseline to 3.5 hours after intervention
Change in concentration of blood leucocytes (x10^9/L)
Change in leucocytes from baseline to the end of the sipping period
Measured: Change from baseline to 3.5 hours after intervention
Change in concentration of stress hormones (glucagon, cortisol, adrenalin, noradrenalin)
Change in hormones from baseline and after 3.5 hour sipping period
Measured: Change from baseline to 3.5 hours after intervention
Change in intracellular muscle signalling
Change in muscle signalling in muscle biopsies by western blot from baseline to the sipping period
Measured: Change from baseline to 3.5 hours after intervention
Difference in muscle forearm kinetics measured by phenylalanine tracer (Netbalance, rate of apperance, rate og disappearance) (healthy vs catabolic)
Phenylalanine forearm kinetics measured by phenylalanine tracer at the end of the 3.5 hour basal period in healthy vs catabolic (pooled mean of the two catabolic days, if there is no difference between the first and second time of LPS exposure)
Measured: measured at the end of the 3.5 hour basal period
Difference in concentration of total amino acids (healthy vs catabolic)
Total amino acids measured at the end of the 3.5 hour basal period in healthy vs catabolic conditions (pooled mean of the two catabolic days, if there is no difference between the first and second time of LPS exposure)
Measured: measured at the end of the 3.5 hour basal period
Difference in glucose kinetics measured with glucose tracer (mg/kg/min) (healthy vs catabolic)
Glucose kinetics measured by glucose tracer at the end of the 3.5 hour basal period in healthy vs catabolic conditions (pooled mean of the two catabolic days, if there is no difference between the first and second time of LPS exposure)
Measured: measured at the end of the 3.5 hour basal period
Difference in concentration of free fatty acids (FFA) (healthy vs catabolic)
FFA measured at the end of the basal period in healthy vs catabolic (pooled mean of the two catabolic days)
Measured: Measured at the end of the 3.5 hour basal period.
Difference in concentration of C-reactive peptide (CRP) (healthy vs catabolic)
CRP measured at the end of the basal period in healthy vs catabolic (pooled mean of the two catabolic days)
Measured: Measured at the end of the 3.5 hour basal period.
Difference in concentration of leucocytes (healthy vs catabolic)
Leucocytes measured at the end of the basal period in healthy vs catabolic (pooled mean of the two catabolic days)
Measured: Measured at the end of the 3.5 hour basal period.
Difference in intracellular muscle signalling (healthy vs catabolic)
Muscle signalling measured in muscle biopsies by western blot during the 3.5 hour basal period in healthy vs catabolic (pooled mean of the two catabolic days)
Measured: Measured at the end of the 3.5 hour basal period.
Difference in concentration of 3-hydroxybutyrate (mmol/L) (healthy vs catabolic)
3-hydroxybutyrate measured at the end of the basal period in healthy vs catabolic (pooled mean of the two catabolic days)
Measured: Measured at the end of the 3.5 hour basal period.
Difference in concentration of hormones (insulin, glucagon, cortisol, growth hormone, adrenaline, noradrenalin) (healthy vs catabolic)
Hormones (insulin, glucagon, cortisol, growth hormone, adrenaline, noradrenalin) measured at the end of the basal period in healthy vs catabolic (pooled mean of the two catabolic days)
Measured: Measured at the end of the 3.5 hour basal period.
Difference in whole body protein metabolism (healthy vs catabolic)
Difference in whole body protein metabolism measured with tyrosine tracers at the end of the basal period in healthy vs catabolic (pooled mean of the two catabolic days)
Measured: Measured at the end of the 3.5 hour basal period.
Difference in concentration of cytokines (healthy vs catabolic)
Cytokines (TNFalfa, IL-10, IL-6 and IL-1beta) measured between healthy and catabolic conditions (iAUC, a pooled mean of the two catabolic days, if there is no difference between the first and second time of LPS exposure))
Measured: Measured at baseline and 120 and 240 minutes after LPS administration
Difference in axillary temperature (healthy vs catabolic)
Change in axillary temperature (iAUC). A pooled mean of the two catabolic days, if there is no difference between the first and second time of LPS exposure.
Measured: Measured at baseline and 1, 2, 3, 4, 5, 6 and 7 hours after LPS administration
Difference in heart rate (healthy vs catabolic)
Change in heart rate (iAUC). A pooled mean of the two catabolic days, if there is no difference between the first and second time of LPS exposure.
Measured: Measured at baseline and 1, 2, 3, 4, 5, 6 and 7 hours after LPS administration
Difference in mean arterial pressure (MAP) (healthy vs catabolic)
Change in MAP (iAUC). A pooled mean of the two catabolic days, if there is no difference between the first and second time of LPS exposure.
Measured: Measured at baseline and 1, 2, 3, 4, 5, 6 and 7 hours after LPS administration
Difference in symptom score (healthy vs catabolic)
Change from baseline and throughout the experiment (iAUC). A pooled mean of the two catabolic days, if there is no difference between the first and second time of LPS exposure. Scale 0-5, 0=no symptoms and 5=severe symptoms
Measured: Measured at baseline and 1, 2, 3, 4, 5, 6 and 7 hours after LPS administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2019
- Study start17 Jun 2019
- Primary completion23 Jan 2020
- Study completion23 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndotoxemiaStudies 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
- 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
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Arla Foods, Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Niels Moeller, Professor, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04064268
- Sponsor's protocol ID
- Ketone Study
- Status last verified
- Jul 2019
- First submitted
- 11 Jul 2019
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anabolic Potential of Adding 3-hydroxybutyrate (3-OHB) to Whey Protein in a Catabolic Inflammatory Disease Model: A Human Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04064268
- Acronym / sponsor ID
- Ketone Study
- Conditions
- Endotoxemia, Muscle Loss, Catabolic State, Protein; Disease, Nutrition Therapy
- Keywords
- endotoxemia, muscle loss, catabolic state, whey protein, 3-hydroxy butyrate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Arla Foods, Aarhus University Hospital
- Study start
- 17 Jun 2019 (actual)
- Primary completion
- 23 Jan 2020 (actual)
- Study completion
- 23 Jan 2020 (actual)
- First posted
- 21 Aug 2019 (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 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.
Detailed description
Background: Muscle wasting during hospitalization is caused by a combination of immobilization (bed rest), hypocaloric diet and inflammation (e.g. sepsis), and preventive measures are needed. Whey protein is particularly potent in inducing muscle protein synthesis compared with other proteins, at least in healthy populations. Further, the ketone body 3-hydroxybutyrate (3-OHB) effectively preserved muscle in a model of acute inflammatory disease. However, little is known about whether 3-OHB can potentiate the effects of whey protein in a catabolic inflammatory setting.
Aim: This study aims to investigate the muscle anabolic potential of adding ketone (3-OHB) to whey protein compared with isocaloric, isonitrogenous whey protein in a human model of catabolic inflammatory 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.
Hypothesis:
- 3-OHB potentiates the effect of whey protein in maintaining muscle mass in a catabolic inflammatory setting.
- The same amount of whey protein will have decreased muscle anabolic effects during catabolic inflammatory conditions compared with healthy conditions Interventions: In a randomized crossover design, eight healthy, lean, young men will undergo either:
- 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^" *LPS will be administered (1 ng/kg) the day prior to the study together with fast and bed rest. On the study day LPS (0.5 ng/kg) will be injected. ^Beverages will be isonitrogenous and isocaloric (fat will be added) with 45 g whey protein + 20 g maltodextrin. Bolus/sip administration will be applied (1/3 bolus, 1/2 sip) " 50 grams of 3-OHB will be orally administered (1/2 bolus, 1/2 sip) Before each study day: The participants arrive fasting (only tap water allowed) by taxi on the study days. They have been without febrile disease the week prior to investigation, and have not performed exercise for 24 hours.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Healthy + Whey | Experimental | Dietary Supplement: WheyHealthy conditions (overnight fast) |
| Catabolic + Whey | Experimental | Dietary Supplement: WheyCatabolic conditions (36-hour fast, bed rest and inflammation (LPS)) |
| Catabolic + 3-OHB / Whey | Experimental | Dietary Supplement: 3-OHB + WheyCatabolic conditions (36-hour fast, bed rest and inflammation (LPS)) |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- Recent immobilization of an extremity that is not fully rehabilitated
- Lactose, lidocain or rubber allergies
- Current disease
- Use of anabolic steroids
- Smoking
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 |
|---|---|---|
| Whey45 g whey + 20 g maltodextrin | Dietary supplement | Catabolic + Whey, Healthy + Whey |
| 3-OHB + Whey50 g ketone + 45 g whey + 20 g maltodextrin | Dietary supplement | Catabolic + 3-OHB / Whey |
Primary outcome
Change in forearm muscle kinetics measured by phenylalanine tracer (Netbalance, rate of disappearence and rate of apperance of phenylanine, nmol/100ml muscle/min)
Time frame: Change from baseline to 3.5 hours after intervention
Changes of forearm muscle phenylalanine kinetics from baseline to 3.5 hours after intervention using the forearm model
25 secondary outcomes
Change in concentration of total aminoacids
Time frame: Change from baseline to 3.5 hours after intervention
Change in concentration of 3-hydroxybutyrate (mmol/L) )
Time frame: 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)
Time frame: Change from baseline to 3.5 hours after intervention
Change in concentration of plasma insulin
Time frame: Measured at baseline and every 30. min throughout the 3.5 hour sipping period
Change in concentration of plasma glucose
Time frame: Measured at baseline and every 30. min throughout the 3.5 hour sipping period
Change in concentration of free fatty acids (FFA) levels
Time frame: Change from baseline to 3.5 hours after intervention
Change in concentration of C-reactive peptide (CRP)
Time frame: Change from baseline to 3.5 hours after intervention
Change in concentration of blood leucocytes (x10^9/L)
Time frame: Change from baseline to 3.5 hours after intervention
Change in concentration of stress hormones (glucagon, cortisol, adrenalin, noradrenalin)
Time frame: Change from baseline to 3.5 hours after intervention
Change in intracellular muscle signalling
Time frame: Change from baseline to 3.5 hours after intervention
Difference in muscle forearm kinetics measured by phenylalanine tracer (Netbalance, rate of apperance, rate og disappearance) (healthy vs catabolic)
Time frame: measured at the end of the 3.5 hour basal period
Difference in concentration of total amino acids (healthy vs catabolic)
Time frame: measured at the end of the 3.5 hour basal period
Difference in glucose kinetics measured with glucose tracer (mg/kg/min) (healthy vs catabolic)
Time frame: measured at the end of the 3.5 hour basal period
Difference in concentration of free fatty acids (FFA) (healthy vs catabolic)
Time frame: Measured at the end of the 3.5 hour basal period.
Difference in concentration of C-reactive peptide (CRP) (healthy vs catabolic)
Time frame: Measured at the end of the 3.5 hour basal period.
Difference in concentration of leucocytes (healthy vs catabolic)
Time frame: Measured at the end of the 3.5 hour basal period.
Difference in intracellular muscle signalling (healthy vs catabolic)
Time frame: Measured at the end of the 3.5 hour basal period.
Difference in concentration of 3-hydroxybutyrate (mmol/L) (healthy vs catabolic)
Time frame: Measured at the end of the 3.5 hour basal period.
Difference in concentration of hormones (insulin, glucagon, cortisol, growth hormone, adrenaline, noradrenalin) (healthy vs catabolic)
Time frame: Measured at the end of the 3.5 hour basal period.
Difference in whole body protein metabolism (healthy vs catabolic)
Time frame: Measured at the end of the 3.5 hour basal period.
Difference in concentration of cytokines (healthy vs catabolic)
Time frame: Measured at baseline and 120 and 240 minutes after LPS administration
Difference in axillary temperature (healthy vs catabolic)
Time frame: Measured at baseline and 1, 2, 3, 4, 5, 6 and 7 hours after LPS administration
Difference in heart rate (healthy vs catabolic)
Time frame: Measured at baseline and 1, 2, 3, 4, 5, 6 and 7 hours after LPS administration
Difference in mean arterial pressure (MAP) (healthy vs catabolic)
Time frame: Measured at baseline and 1, 2, 3, 4, 5, 6 and 7 hours after LPS administration
Difference in symptom score (healthy vs catabolic)
Time frame: Measured at baseline and 1, 2, 3, 4, 5, 6 and 7 hours after LPS administration
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 11 Jun 2020.
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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
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whey and 3-OHB + Whey in people with Endotoxemia and Muscle Loss, 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 4 inclusion and 10 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 11 Jun 2020. 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 forearm muscle kinetics measured by phenylalanine tracer (Netbalance, rate of disappearence and rate of apperance of phenylanine, nmol/100ml muscle/min) (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?
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 11 Jun 2020.