NCT03952884

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 3, 2019

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 8, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 16, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2019

Completed
Last Updated

September 28, 2020

Status Verified

September 1, 2020

Enrollment Period

7 months

First QC Date

May 8, 2019

Last Update Submit

September 24, 2020

Conditions

Keywords

MetabolismAmino Acid PeptidesMuscle Protein SynthesisMuscle Protein Breakdown

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    Postprandial for 1 hour

Secondary Outcomes (1)

  • Phosphorylation of muscle anabolic signaling

    Baseline, immediately after ingestion of leucine/leucine peptides, and 3 hours after ingestion of leucine/leucine peptides

Study Arms (2)

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.

Behavioral: Resistance ExerciseBehavioral: No Resistance ExerciseDietary 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.

Behavioral: Resistance ExerciseBehavioral: No Resistance ExerciseDietary Supplement: Dileucine

Interventions

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.

LeucineLeucine Peptide (Dileucine)

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.

LeucineLeucine Peptide (Dileucine)
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.

Leucine
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.

Leucine Peptide (Dileucine)

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Recreationally-active adults: ≥ 30 min of physical activity at moderate intensity ≥ 3 times per week
  • Ages: 18-35 years old
  • English fluency

You may not qualify if:

  • 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
  • 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)
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Freer Hall

Urbana, Illinois, 61801, United States

Location

MeSH Terms

Interventions

Resistance TrainingLeucine

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaAmino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Essential

Study Officials

  • Nicholas A. Burd, Ph.D.

    University of Illinois at Urbana-Champaign

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 8, 2019

First Posted

May 16, 2019

Study Start

May 3, 2019

Primary Completion

November 20, 2019

Study Completion

November 20, 2019

Last Updated

September 28, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations