NCT03501628

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2016

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

August 17, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 17, 2017

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

August 31, 2017

Completed
8 months until next milestone

First Posted

Study publicly available on registry

April 18, 2018

Completed
Last Updated

April 18, 2018

Status Verified

April 1, 2018

Enrollment Period

9 months

First QC Date

August 31, 2017

Last Update Submit

April 10, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Index of skeletal muscle hypertrophy

    Whole-body dual x-ray absorptiometry scan for lean body mass assessment (units in kilograms)

    Pre- and post-intervention assessments (12-week seperation between assessments)

Secondary Outcomes (3)

  • Index of muscle hypertrophy at the cellular level

    Pre- and post-intervention assessments (12-week seperation between assessments)

  • Index of whole-body adiposity

    Pre- and post-intervention assessments (12-week seperation between assessments)

  • Index of cellular adiposity

    Pre- and post-intervention assessments (12-week seperation between assessments)

Study Arms (5)

Placebo

PLACEBO COMPARATOR

2 servings daily Serving information: * 204 kcal * 2.8 g fat * 44.4 g carbohydrate * 0.4 g protein (0 g L-leucine)

Dietary Supplement: Placebo

L-leucine + maltodextrin

EXPERIMENTAL

2 servings daily Serving information: * 200 kcal * 2.0 g fat * 43.1 g carbohydrate * 2.8 g protein (2.8 g L-leucine)

Dietary Supplement: L-leucine + maltodextrin

Whey protein concentrate

EXPERIMENTAL

2 servings daily Serving information: * 184 kcal * 3.5 g fat * 12 g carbohydrate * 26.3 g protein (2.8 g L-leucine)

Dietary Supplement: Whey protein concentrate

Hydrolyzed whey protein concentrate

EXPERIMENTAL

2 servings daily Serving information: * 192 kcal * 4.6 g fat * 12.2 g carbohydrate * 25.4 g protein (2.9 g L-leucine)

Dietary Supplement: Hydrolyzed whey protein concentrate

Soy protein concentrate

EXPERIMENTAL

2 servings daily Serving information: * 266 kcal * 4.5 g fat * 17.2 g carbohydrate * 39.2 g protein (2.9 g L-leucine)

Dietary Supplement: Soy protein concentrate

Interventions

PlaceboDIETARY_SUPPLEMENT

Supplementation twice daily (1 serving dose per consumption) of maltodextin while engaging in resistance training 3 times per week for a 12-week period. Supplementation occurred during training and non-training days.

Placebo
L-leucine + maltodextrinDIETARY_SUPPLEMENT

Supplementation twice daily (1 serving dose per consumption) of L-leucine + maltodextin while engaging in resistance training 3 times per week for a 12-week period. Supplementation occurred during training and non-training days.

L-leucine + maltodextrin
Whey protein concentrateDIETARY_SUPPLEMENT

Supplementation twice daily (1 serving dose per consumption) of whey protein concentrate while engaging in resistance training 3 times per week for a 12-week period. Supplementation occurred during training and non-training days.

Whey protein concentrate

Supplementation twice daily (1 serving dose per consumption) of hydrolyzed whey protein concentrate while engaging in resistance training 3 times per week for a 12-week period. Supplementation occurred during training and non-training days.

Hydrolyzed whey protein concentrate
Soy protein concentrateDIETARY_SUPPLEMENT

Supplementation twice daily (1 serving dose per consumption) of soy protein concentrate while engaging in resistance training 3 times per week for a 12-week period. Supplementation occurred during training and non-training days.

Soy protein concentrate

Eligibility Criteria

Age19 Years - 35 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMales
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • are between the ages of 19-35 and have a body mass index (body mass in kilograms/ height in meters\^2) between 23-30
  • are apparently healthy and do not have any known illnesses that are contraindicated for exercise (i.e., hypertension, arrhythmias, or cardiopulmonary diseases), or are not taking medications for these diseases
  • have not engaged in lower-body weight training over the past 12 months; this means less than one training session per every two weeks
  • have not engaged in lower-body endurance training over the past 12 months; this means that the participant has not run more than 10 miles per week or road-biked/swam more than 2 days per week
  • have not consumed nutritional supplements two months prior to the study including hormone boosters, protein supplements, amino acid supplements and/or creatine monohydrate
  • are not regular tobacco users, or haven't been over the past 12 months
  • do not have any blood clotting issues and/or are on blood-thinning agents or medications

You may not qualify if:

  • are not between the ages of 19-35 or have a body mass index (body mass in kilograms/ height in meters\^2) outside the range of 23-30
  • have any known illnesses that are contraindicated for exercise (i.e., hypertension, arrhythmias, or cardiopulmonary diseases), or are not taking medications for these diseases
  • have engaged in lower-body weight training over the past 12 months
  • have engaged in lower-body endurance training over the past 12 months
  • have consumed nutritional supplements two months prior to the study including hormone boosters, protein supplements, amino acid supplements and/or creatine monohydrate
  • are tobacco users
  • have any blood clotting issues and/or are on blood-thinning agents or medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

LeucinemaltodextrinWhey

Intervention Hierarchy (Ancestors)

Amino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, EssentialMilkBeveragesDiet, Food, and NutritionPhysiological PhenomenaDairy ProductsFoodFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 31, 2017

First Posted

April 18, 2018

Study Start

August 17, 2016

Primary Completion

May 17, 2017

Study Completion

August 17, 2017

Last Updated

April 18, 2018

Record last verified: 2018-04