NCT03501628: MPS

Leucine or Protein Supplementation and Resistance Training

Completed NA Last updated 18 April 2018

What this trial tests

NA trial testing Placebo in Skeletal Muscle in 89 participants. Completed in 17 August 2017.

Timeline

17 August 2016

Primary endpoint
17 May 2017

17 August 2017

Quick facts

Lead sponsor	Auburn University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	89
Start date	17 August 2016
Primary completion	17 May 2017
Estimated completion	17 August 2017

Drugs / interventions tested

• Placebo
• L-leucine + maltodextrin
• Whey protein concentrate
• Hydrolyzed whey protein concentrate
• Soy protein concentrate

Conditions studied

• Skeletal Muscle — all drugs for Skeletal Muscle →

Sponsor

Auburn University

Who can join

Adults 19 to 35, male only, with Skeletal Muscle. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study was to determine the effects of L-leucine (LEU) or different protein supplements standardized to LEU (\~3.0 g/serving) on changes in body composition, strength, and histological attributes in skeletal muscle and adipose tissue. Seventy-five untrained, college-aged males (mean±SE; age=21±1 yr, body mass=79.2±0.3 kg) were randomly assigned to an isocaloric, lipid-, and organoleptically-matched maltodextrin placebo (PLA, n=15), LEU (n=14), whey protein concentrate (WPC, n=17), whey protein hydrolysate (WPH, n=14), or soy protein concentrate (SPC, n=15) group. Participants performed whole-body resistance training three days per week for 12 weeks while consuming supplements twice daily. Skeletal muscle and subcutaneous (SQ) fat biopsies were obtained at baseline (T1) and \~72 h following the last day of training (T39). Tissue samples were analyzed for changes in type I and II fiber cross sectional area (CSA), non-fiber specific satellite cell count, and SQ adipocyte CSA. On average, all supplement groups including PLA exhibited similar training volumes and experienced statistically similar increases in total body skeletal muscle mass determined by dual x-ray absorptiometry (+2.2 kg; time p=0.024) and type I and II fiber CSA increases (+394 µm2 and +927 µm2; time p\<0.001 and 0.024, respectively). Notably, all groups reported increasing Calorie intakes \~600-800 kcal/d from T1 to T39 (time p\<0.001), and all groups consumed at least 1.1 g/kg/d of protein at T1 and 1.3 g/kg/d at T39. There was a training, but no supplementation, effect regarding the reduction in SQ adipocyte CSA (-210 µm2; time p=0.001). Interestingly, satellite cell counts within the WPC (p\<0.05) and WPH (p\<0.05) groups were greater at T39 relative to T1. In summary, LEU or protein supplementation (standardized to LEU content) does not provide added benefit in increasing whole-body skeletal muscle mass or strength above PLA following 3 months of training in previously untrained college-aged males that increase Calorie intakes with resistance training and consume above the recommended daily intake of protein throughout training. However, whey protein supplementation increases skeletal muscle satellite cell number in this population, and this phenomena may promote more favorable training adaptations over more prolonged periods.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Skeletal muscle mitochondrial volume and myozenin-1 protein differences exist between high versus low anabolic responders to resistance training.
   Roberts MD, Romero MA, Mobley CB, Mumford PW, et al · · 2018 · cited 40× · PMID 30065891 · DOI 10.7717/peerj.5338
2. Soy protein supplementation is not androgenic or estrogenic in college-aged men when combined with resistance exercise training.
   Haun CT, Mobley CB, Vann CG, Romero MA, et al · · 2018 · cited 15× · PMID 30042516 · DOI 10.1038/s41598-018-29591-4