Muscle Protein SynthesisNCT04121689
Time Course of Postprandial Protein Metabolism
A study testing Milk Protein Concentrate in people with Muscle Protein Synthesis and Protein Metabolism, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial summary
The anabolic action of 'fast' whey protein on the regulation of postprandial muscle protein synthesis has been established to be short-lived in healthy young adults. Our aim was assess the time course of anabolic signaling events and stimulation of muscle protein synthesis rates (MPS) after ingestion of a food source… Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Protein Synthesis, Protein Metabolism
- What is being tested?
- Milk Protein Concentrate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2014to 26 Aug 2019
- 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 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males
- Aged between 18-35 years
- Healthy, recreationally active
- BMI < 30 kg/m2
Who cannot join
- Smoking
- Allergies to milk proteins
- Vegetarians
- Diagnosed GI tract diseases
- Female
- Arthritic conditions
Show all 10Show fewer
- A history of neuromuscular problems
- Previous participation in amino acid tracer studies
- Predisposition to hypertrophic scarring or keloid formation
- Individuals on any medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories, or prescription strength acne medications).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Time-dependent Regulation of Postprandial Muscle Protein Synthesis After Milk Protein Ingestion in Young Men
The anabolic action of 'fast' whey protein on the regulation of postprandial muscle protein synthesis has been established to be short-lived in healthy young adults. Our aim was assess the time course of anabolic signaling events and stimulation of muscle protein synthesis rates (MPS) after ingestion of a food source that represents a more typical meal-induced pattern of aminoacidemia, namely milk protein concentrate, in healthy young males.
- Conditions
- Muscle Protein Synthesis, Protein Metabolism
- Being tested
- Milk Protein Concentrate
- Keywords
- Protein, Amino Acids, Anabolic Signaling, Muscle Mass
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Milk Protein ConcentrateDietary supplement
The macronutrient composition and energy of the milk protein beverage provided to participants is 38 g protein (3.46 g leucine), 4.17 g carbohydrate, and 1.4 g fat. The milk protein met all chemical and bacteriologic specifications for human consumption. The L-[1-13C]phenylalanine and L-[1-13C]leucine enrichments in the milk protein concentrate averaged 38.3 and 10.8 mole percent excess (MPE), respectively.
| Study group | Role | What they receive |
|---|---|---|
| Milk Protein Concentrate | Experimental | Seven young men (age: 22±1 y) will undergo repeated blood and biopsy sampling during primed continuous L-[ring-2H5]phenylalanine and L-[1-13C]leucine tracer infusions, and ingested 38 g of L-[1-13C]phenylalanine- and L-[1-13C]leucine-labeled milk protein concentrate Receives: Dietary Supplement: Milk Protein Concentrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractional synthesis rates of myofibrillar protein
Myofibrillar protein synthesis rates will be assessed during the postabsorptive period for 3 hours, and every 1-2 hours during the 5 hours after protein ingestion. This will allow us assess the timecourse of muscle protein synthesis after eating.
Measured: 8 hours
Secondary outcomes (2)
Phosphorylation of muscle anabolic signaling
Phosphorylation of anabolic signaling pathways (mTORC1, AKT, and P70S6K) involved in the stimulation of myofibrillar protein synthesis rates will be assessed during the postabsorptive period for 3 hours, and every 1-2 hours during the 5 hours after protein ingestion.
Measured: 8 hours
Exogenous rate of phenylalanine appearance
Dietary derived phenylalanine availability will be measured during the 5 h postprandial phase to determine its relationship with the fractional synthesis rates of myofibrillar protein and phosphorylation of muscle anabolic signaling
Measured: 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start1 Oct 2014
- Primary completion1 Nov 2014
- Study completion26 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle Protein SynthesisStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04121689
- Sponsor's protocol ID
- 14234
- Status last verified
- Aug 2019
- First submitted
- 3 Sep 2019
- Last updated
- 10 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time-dependent Regulation of Postprandial Muscle Protein Synthesis After Milk Protein Ingestion in Young Men
- ClinicalTrials.gov ID
- NCT04121689
- Acronym / sponsor ID
- 14234
- Conditions
- Muscle Protein Synthesis, Protein Metabolism
- Keywords
- Protein, Amino Acids, Anabolic Signaling, Muscle Mass
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Study start
- 1 Oct 2014 (actual)
- Primary completion
- 1 Nov 2014 (actual)
- Study completion
- 26 Aug 2019 (actual)
- First posted
- 10 Oct 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.
The anabolic action of 'fast' whey protein on the regulation of postprandial muscle protein synthesis has been established to be short-lived in healthy young adults. Our aim was assess the time course of anabolic signaling events and stimulation of muscle protein synthesis rates (MPS) after ingestion of a food source that represents a more typical meal-induced pattern of aminoacidemia, namely milk protein concentrate, in healthy young males.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Milk Protein Concentrate | Experimental | Dietary Supplement: Milk Protein ConcentrateSeven young men (age: 22±1 y) will undergo repeated blood and biopsy sampling during primed continuous L-[ring-2H5]phenylalanine and L-[1-13C]leucine tracer infusions, and ingested 38 g of L-[1-13C]phenylalanine- and L-[1-13C]leucine-labeled milk protein concentrate |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Males
- Aged between 18-35 years
- Healthy, recreationally active
- BMI < 30 kg/m2
Key exclusion criteria (10 listed)
- Smoking
- Allergies to milk proteins
- Vegetarians
- Diagnosed GI tract diseases
- Female
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 |
|---|---|---|
| Milk Protein ConcentrateThe macronutrient composition and energy of the milk protein beverage provided to participants is 38 g protein (3.46 g leucine), 4.17 g carbohydrate, and 1.4 g fat. The milk protein met all chemical and bacteriologic specifications for human consumption. The L-[1-13C]phenylalanine and L-[1-13C]leucine enrichments in the milk protein concentrate averaged 38.3 and 10.8 mole percent excess (MPE), respectively. | Dietary supplement | Milk Protein Concentrate |
Primary outcome
Fractional synthesis rates of myofibrillar protein
Time frame: 8 hours
Myofibrillar protein synthesis rates will be assessed during the postabsorptive period for 3 hours, and every 1-2 hours during the 5 hours after protein ingestion. This will allow us assess the timecourse of muscle protein synthesis after eating.
2 secondary outcomes
Phosphorylation of muscle anabolic signaling
Time frame: 8 hours
Exogenous rate of phenylalanine appearance
Time frame: 5 hours
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 10 Oct 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Milk Protein Concentrate in people with Muscle Protein Synthesis and Protein Metabolism, run by University of Illinois at Urbana-Champaign at 1 site in United States.
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 10 Oct 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 United States. 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?
Fractional synthesis rates of myofibrillar protein (time frame: 8 hours). 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 10 Oct 2019.