Influence of Leucine Enriched Amino Acids on Myofibrillar and Collagen Protein Synthesis

NCT05554653 | Unknown

• 1 other identifier: ULE
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective will be to determine the effect of leucine-enriched essential amino acids (LEAA) compared to carbohydrate placebo on dietary incorporation of \[D5\] Phenylalanine \& \[D5\] Glycine into the three skeletal muscle protein pools (myofibrillar, sarcoplasmic and collagen), both following resistance exercise and at rest, with the two tracers provided as a 'intrinsically labeled' bolus. Other outcomes will relate to molecular regulation of protein synthesis.

Conditions

Interventional

Keywords

Leucine-enriched amino acids; Carbohydrate Placebo

Outcome Measures

Primary Outcomes (1)

• Myofibrillar Protein synthesis

  Rate of incorporation of orally ingested amino acid tracers (D5 Phe and D5 Gly) into myofibrillar proteins isolated from skeletal muscle biopsies 4h following drink (LEAA or PLA) consumption and resistance exercise or at rest. Enrichment will be quantified via tandem LC-MS/MS to derive a rate of incorporation over the 4h period.

  4 hours

Secondary Outcomes (3)

• Sarcoplasmic protein synthesis

  4 hours

• Collagen protein synthesis

  4 hours

• Protein localization via immunofluorescence

  4 hours

Other Outcomes (1)

• Isolation of primary myoblasts for in vitro nutritional experiments

  6-9 months

Study Arms (2)

Leucine enriched essential amino acids

ACTIVE COMPARATOR

Leucine enriched essential amino acids (4g total, of which 1.6g are leucine). 20g carbohydrate, 2g of protein free drink powder, and 5g of Splenda to mask taste.

Dietary Supplement: Leucine enriched amino acids

Carbohdyrate Placebo

PLACEBO COMPARATOR

Iso-caloric placebo (4g maltodextrin to replace LEAA). 20g carbohydrate, 2g of protein free drink powder, and 5g of Splenda to mask taste.

Dietary Supplement: Carbohydrate Placebo

Interventions

Leucine enriched amino acids DIETARY_SUPPLEMENT

Leucine enriched essential amino acids (4g total, of which 1.6g are leucine). 20g carbohydrate, 2g of protein free drink powder, and 5g of Splenda.

Also known as: LEAA

Leucine enriched essential amino acids

Carbohydrate Placebo DIETARY_SUPPLEMENT

iso-caloric placebo (4g maltodextrin). 20g carbohydrate, 2g of protein free drink powder, and 5g of Splenda.

Carbohdyrate Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy, male and female, recreationally-active participants.
• Healthy will be defined as screened by the PAR-Q+ (The Physical Activity Readiness Questionnaire for everyone; Appendix B).
• Self-reported not having engaged in resistance exercise and/or lower body plyometrics for at least 3 months prior to the study.
• Participants will be aged 18-35 years old.
• Participants are willing to abide by the compliance rules of this study.
• Self-reported regular menstrual cycle (25-35d) within the last 3 months (female participants).

You may not qualify if:

• Inability to adhere to any of the compliance rules judged by principle investigator or medical doctor.
• Self-reported regular tobacco use.
• Self-reported illicit drug use (e.g. growth hormone, testosterone, etc.).
• Individuals who have participated in studies within the past year involving any of the stable isotopes in the study.
• Use of birth control and discontinued use within the last 3 months (female participants).

Sponsors & Collaborators

• Daniel Moore: lead

Study Sites (1)

Goldring Centre for High Performance Sport at the University of Toronto

Toronto, Ontario, M5S2C9, Canada

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blinded (investigators and participants). A lab member external to the investigation will code items for the intervention.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Crossover to receive LEAA or Carbohydrate placebo. Unilateral leg exercise to give 4 outcome. (1) LEAA-EX; (2) LEAA-REST; (3) PLACEBO-EX; (4) PLACEBO-REST

Study Record Dates

• First Submitted: September 19, 2022
• First Posted: September 26, 2022
• Study Start: October 1, 2022
• Primary Completion: October 3, 2023
• Study Completion: August 1, 2024
• Last Updated: November 13, 2023

Record last verified: 2023-11

Locations

CA (1)