Protein MetabolismNCT03952884
Skeletal Muscle Protein Synthetic Response to Amino Acid and Peptides
A study testing Resistance Exercise, No Resistance Exercise and Leucine in people with Protein Metabolism, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial summary
Skeletal muscle quality is an important determinant of exercise performance and overall health. It is vital for not just movement, but also metabolizing nutrients. Protein from the diet can promote muscle protein synthesis for muscle recovery and growth. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Protein Metabolism
- What is being tested?
- Resistance Exercise, No Resistance Exercise and Leucine
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2019to 20 Nov 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Recreationally-active adults: ≥ 30 min of physical activity at moderate intensity ≥ 3 times per week
- Ages: 18-35 years old
- English fluency
Who cannot join
- Tobacco, nicotine (patch/gum) use (previous 6 mo)
- Alcohol consumption >10 drinks per week
- Metabolic disorders (e.g., Metabolic Syndrome, Diabetes, thyroid diseases)
- Cardiovascular disease, arrhythmias
- Hypogonadism
- Asthma
Show all 16Show fewer
- History of uncontrolled hypertension
- Orthopedic injury/surgery (within 1 yr)
- Hepatorenal, musculoskeletal, autoimmune, or neurological disease
- History of neuromuscular problems
- Previous participation in amino acid tracer studies
- Predisposition to hypertrophic scarring or keloid formation
- Consumption of ergogenic-levels of dietary supplements that may affect muscle mass (e.g., creatine, HMB), insulin-like substances, or anabolic/catabolic pro-hormones (e.g., DHEA) within 6 weeks prior to participation
- Consumption of thyroid, androgenic, or other medications known to affect endocrine function
- Consumption of medications known to affect protein metabolism (e.g., prescription-strength corticosteroids, non-steroidal anti-inflammatories, or acne medication)
- Currently pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Skeletal muscle quality is an important determinant of exercise performance and overall health. It is vital for not just movement, but also metabolizing nutrients. Protein from the diet can promote muscle protein synthesis for muscle recovery and growth. More importantly, doing so shifts net protein balance positively (e.g. protein synthesis is greater than protein breakdown) and promotes greater rates of muscle protein turnover. Leucine is an amino acid required to build muscle, but it also acts as a signaling molecule informing the muscle to start protein synthesis. Before reaching skeletal muscle, dietary protein is digested into small peptides and free amino acids. Rate of absorption from the intestine to the blood stream is significantly faster for peptides compared to amino acids. As amino acid availability in the blood is a precursor for muscle protein synthesis, our objective is to determine if the different absorption rates between free amino acid and peptides influence muscle protein synthetic and breakdown rates.
- Conditions
- Protein Metabolism
- Being tested
- Resistance Exercise, No Resistance Exercise, Leucine, Dileucine
- Keywords
- Metabolism, Amino Acid Peptides, Muscle Protein Synthesis, Muscle Protein Breakdown
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance ExerciseBehavioural
Prior to protein consumption participants will perform an acute bout of resistance exercise. They will warm up with two sets of 10 repetitions at 35-75% working load respectively, then perform four working sets of 10-12 repetitions at 65-70% of 1-RM. 1 min, 30 sec rest periods will be implemented between each set.
No Resistance ExerciseBehavioural
Participants allocated to this group will not perform exercise prior to the administration of the nutritional intervention. Participants will remain at rest throughout the trial.
LeucineDietary supplement
Participants will be given 2g of leucine dissolved in 250mL of water. Drink will be consumed immediately after exercise or equivalent time point for non-exercise group.
DileucineDietary supplement
Participants will be given 2g of dileucine dissolved in 250mL of water. Drink will be consumed immediately after exercise or equivalent time point for non-exercise group.
| Study group | Role | What they receive |
|---|---|---|
| Leucine | Active comparator | Participants will be allocated to an exercise or non-exercise group. After resistance exercise (or equivalent time point for non-exercise group), participants will consume 2g leucine powder dissolved in 250 mL of water. Receives: Behavioral: Resistance Exercise; Behavioral: No Resistance Exercise; Dietary Supplement: Leucine |
| Leucine Peptide (Dileucine) | Experimental | Participants will be allocated to an exercise or non-exercise group. After resistance exercise (or equivalent time point for non-exercise group), participants will consume 2g protein peptide powder dissolved in 250 mL of water. Receives: Behavioral: Resistance Exercise; Behavioral: No Resistance Exercise; Dietary Supplement: Dileucine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractional Synthetic Rate of Mixed Muscle Proteins
Mixed muscle protein synthesis rates will be assessed during the 3.5hr Postabsorptive period (e.g. non-fed state) and the 3hr postprandial period (e.g. fed state) for both experimental interventions (e.g. leucine and leucine peptide). This will allow us to assess the change in fractional synthetic rate from the Postabsorptive period to the postprandial period.
Measured: Postabsorptive for 3.5 hours, Postprandial for 3 hours.
Fractional Synthetic Rate of Myofibrillar Proteins
Myofibrillar muscle protein synthesis rates will be assessed during the 3.5hr Postabsorptive period (e.g. non-fed state) and the 3hr postprandial period (e.g. fed state) for both experimental interventions (e.g. leucine and leucine peptide). This will allow us to assess the change in fractional synthetic rate from the Postabsorptive period to the postprandial period.
Measured: Postabsorptive for 3.5 hours, Postprandial for 3 hours.
Fractional Breakdown Rate of Mixed Muscle Proteins
Mixed muscle protein breakdown rates will be assessed during the first hour of the postprandial period (e.g. fed state) for both experimental interventions (e.g. leucine and leucine peptide). This will allow us to assess the change in fractional breakdown rate for each respective experimental intervention.
Measured: Postprandial for 1 hour
Secondary outcomes (1)
Phosphorylation of muscle anabolic signaling
Phosphorylation of anabolic signaling pathways will be assessed in the fasted state and after the ingestion of the experimental interventions.
Measured: Baseline, immediately after ingestion of leucine/leucine peptides, and 3 hours after ingestion of leucine/leucine peptides
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study start3 May 2019
- Primary completion20 Nov 2019
- Study completion20 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Protein MetabolismStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicholas Burd, University of Illinois at Urbana-Champaign
- Investigators
- Nicholas A. Burd, Ph.D., Principal investigator, University of Illinois at Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03952884
- Sponsor's protocol ID
- 18897
- Status last verified
- Sep 2020
- First submitted
- 8 May 2019
- Last updated
- 28 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 28 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skeletal Muscle Protein Synthetic Response to Amino Acid and Peptides
- ClinicalTrials.gov ID
- NCT03952884
- Acronym / sponsor ID
- 18897
- Conditions
- Protein Metabolism
- Keywords
- Metabolism, Amino Acid Peptides, Muscle Protein Synthesis, Muscle Protein Breakdown
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Study start
- 3 May 2019 (actual)
- Primary completion
- 20 Nov 2019 (actual)
- Study completion
- 20 Nov 2019 (actual)
- First posted
- 16 May 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.
Skeletal muscle quality is an important determinant of exercise performance and overall health. It is vital for not just movement, but also metabolizing nutrients. Protein from the diet can promote muscle protein synthesis for muscle recovery and growth. More importantly, doing so shifts net protein balance positively (e.g. protein synthesis is greater than protein breakdown) and promotes greater rates of muscle protein turnover. Leucine is an amino acid required to build muscle, but it also acts as a signaling molecule informing the muscle to start protein synthesis. Before reaching skeletal muscle, dietary protein is digested into small peptides and free amino acids. Rate of absorption from the intestine to the blood stream is significantly faster for peptides compared to amino acids. As amino acid availability in the blood is a precursor for muscle protein synthesis, our objective is to determine if the different absorption rates between free amino acid and peptides influence muscle protein synthetic and breakdown rates.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Leucine | Active comparator | Behavioral: Resistance Exercise, Behavioral: No Resistance Exercise, Dietary Supplement: LeucineParticipants will be allocated to an exercise or non-exercise group. After resistance exercise (or equivalent time point for non-exercise group), participants will consume 2g leucine powder dissolved in 250 mL of water. |
| Leucine Peptide (Dileucine) | Experimental | Behavioral: Resistance Exercise, Behavioral: No Resistance Exercise, Dietary Supplement: DileucineParticipants will be allocated to an exercise or non-exercise group. After resistance exercise (or equivalent time point for non-exercise group), participants will consume 2g protein peptide powder dissolved in 250 mL of water. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Recreationally-active adults: ≥ 30 min of physical activity at moderate intensity ≥ 3 times per week
- Ages: 18-35 years old
- English fluency
Key exclusion criteria (16 listed)
- Tobacco, nicotine (patch/gum) use (previous 6 mo)
- Alcohol consumption >10 drinks per week
- Metabolic disorders (e.g., Metabolic Syndrome, Diabetes, thyroid diseases)
- Cardiovascular disease, arrhythmias
- Hypogonadism
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 |
|---|---|---|
| Resistance ExercisePrior to protein consumption participants will perform an acute bout of resistance exercise. They will warm up with two sets of 10 repetitions at 35-75% working load respectively, then perform four working sets of 10-12 repetitions at 65-70% of 1-RM. 1 min, 30 sec rest periods will be implemented between each set. | Behavioural | Leucine, Leucine Peptide (Dileucine) |
| No Resistance ExerciseParticipants allocated to this group will not perform exercise prior to the administration of the nutritional intervention. Participants will remain at rest throughout the trial. | Behavioural | Leucine, Leucine Peptide (Dileucine) |
| LeucineParticipants will be given 2g of leucine dissolved in 250mL of water. Drink will be consumed immediately after exercise or equivalent time point for non-exercise group. | Dietary supplement | Leucine |
| DileucineParticipants will be given 2g of dileucine dissolved in 250mL of water. Drink will be consumed immediately after exercise or equivalent time point for non-exercise group. | Dietary supplement | Leucine Peptide (Dileucine) |
Primary outcome
Fractional Synthetic Rate of Mixed Muscle Proteins
Time frame: Postabsorptive for 3.5 hours, Postprandial for 3 hours.
Mixed muscle protein synthesis rates will be assessed during the 3.5hr Postabsorptive period (e.g. non-fed state) and the 3hr postprandial period (e.g. fed state) for both experimental interventions (e.g. leucine and leucine peptide). This will allow us to assess the change in fractional synthetic rate from the Postabsorptive period to the postprandial period.
Fractional Synthetic Rate of Myofibrillar Proteins
Time frame: Postabsorptive for 3.5 hours, Postprandial for 3 hours.
Myofibrillar muscle protein synthesis rates will be assessed during the 3.5hr Postabsorptive period (e.g. non-fed state) and the 3hr postprandial period (e.g. fed state) for both experimental interventions (e.g. leucine and leucine peptide). This will allow us to assess the change in fractional synthetic rate from the Postabsorptive period to the postprandial period.
Fractional Breakdown Rate of Mixed Muscle Proteins
Time frame: Postprandial for 1 hour
Mixed muscle protein breakdown rates will be assessed during the first hour of the postprandial period (e.g. fed state) for both experimental interventions (e.g. leucine and leucine peptide). This will allow us to assess the change in fractional breakdown rate for each respective experimental intervention.
1 secondary outcome
Phosphorylation of muscle anabolic signaling
Time frame: Baseline, immediately after ingestion of leucine/leucine peptides, and 3 hours after ingestion of leucine/leucine peptides
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 28 Sep 2020.
- 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.
Nicholas A. Burd, Ph.D. principal investigator
University of Illinois at Urbana-Champaign
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Exercise, No Resistance Exercise and Leucine in people with 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 3 inclusion and 16 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 28 Sep 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 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 Synthetic Rate of Mixed Muscle Proteins (time frame: Postabsorptive for 3.5 hours, Postprandial for 3 hours.). The study lists 3 primary outcomes in all. 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 28 Sep 2020.