NCT02918981

Brief Summary

Using stable isotope methodology, investigators will determine the postabsorptive and postprandial muscle protein synthetic response in 60 female adults (Age 50-79, BMI: \<30 kg/m2) immediately after an acute bout of resistance exercise. Participants will be divided in to 5 groups of twelve women (n=12). Each group will receive a different protein beverage or placebo to consume following the resistance exercise training. Group 1 will consume a beverage consisting of whey protein; group 2 will consume whey protein supplemented with additional leucine; group 3 will consume whey protein supplemented with additional leucine and hydrolyzed whey peptides; group 4 will consume whey protein supplemented with additional leucine and citrulline; group 5 will just consume water. During the testing, blood and muscle samples will be collected.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration 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

First Submitted

Initial submission to the registry

September 20, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 29, 2016

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2019

Completed
Last Updated

November 3, 2020

Status Verified

November 1, 2020

Enrollment Period

2.4 years

First QC Date

September 20, 2016

Last Update Submit

November 2, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • The myofibrillar protein synthetic response to protein ingestion

    Myofibrillar protein synthesis rates will be assessed during the postabsorptive period for 3 hr and during the 4 hr after the ingestion of the experimental beverages. This will allow us to assess the change from the postabsorptive to the postprandial period

    Postabsorptive for 3 hours, Postprandial for 4 hours hours

Secondary Outcomes (1)

  • mTORC1 phosphorylation

    Baseline and at 2 and 4 hours after protein ingestion

Study Arms (5)

Whey protein

ACTIVE COMPARATOR

After resistance exercise, participants aged 50-79 years will consume 14g Whey protein dissolved in 200 mL of water

Behavioral: Resistance ExerciseDietary Supplement: 14 g Whey protein

Whey + Leucine

EXPERIMENTAL

After resistance exercise, participants aged 50-79 years will consume 6.6 g Whey protein + 1.25 g Leucine dissolved in 200 mL of water

Behavioral: Resistance ExerciseDietary Supplement: 6.6 g Whey protein + 1.25 g leucine

Whey + Leucine + Whey peptides

EXPERIMENTAL

After resistance exercise, participants aged 50-79 years will consume 4 g Whey protein + 1.25 g Leucine + 2.6 g Whey peptides dissolved in 200 mL of water

Behavioral: Resistance ExerciseDietary Supplement: 4 g Whey protein + 1.25 g leucine + 2.6 g Whey peptides

Whey + Leucine + Citrulline

EXPERIMENTAL

After resistance exercise, participants aged 50-79 years will consume 6.6 g Whey protein + 1.25 g Leucine + 0.8 g Citrulline dissolved in 200 mL of water

Behavioral: Resistance ExerciseDietary Supplement: 6.6 g Whey protein + 1.25 g leucine + 0.8 g Citrulline

Water

SHAM COMPARATOR

After resistance exercise, participants aged either 20-30 or 50-79 years old will consume 200 mL water

Behavioral: Resistance ExerciseOther: Water control

Interventions

Participants will perform unilateral leg extension exercise immediately prior to ingestion of the experimental beverage

WaterWhey + LeucineWhey + Leucine + CitrullineWhey + Leucine + Whey peptidesWhey protein
14 g Whey proteinDIETARY_SUPPLEMENT
Whey protein
Whey + Leucine
Whey + Leucine + Whey peptides
Whey + Leucine + Citrulline
Water

Eligibility Criteria

Age20 Years - 79 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI \<30 kg/m2
  • Healthy, sedentary
  • Either 20-30 years old or 50-79 years old

You may not qualify if:

  • Tobacco use
  • Allergies to milk consumption
  • Unusually high protein consumption
  • Vegan diet
  • Allergies to antibiotics or xylocaine
  • Phenylketonuria (PKU)
  • Diagnosed GI tract diseases
  • Arthritic conditions
  • A history of neuromuscular problems
  • Heart disease
  • Metabolic disorders
  • Liver, kidney, or urinary disease
  • Musculoskeletal problems
  • Autoimmune disease
  • Neurological disease
  • +8 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 TrainingWhey ProteinsLeucineCitrulline

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaMilk ProteinsAnimal Proteins, DietaryDietary ProteinsProteinsAmino Acids, Peptides, and ProteinsWheyMilkDairy ProductsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesAmino Acids, Branched-ChainAmino AcidsAmino Acids, EssentialAmino Acids, Diamino

Study Officials

  • Nicholas A Burd, Ph.D.

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 20, 2016

First Posted

September 29, 2016

Study Start

October 1, 2016

Primary Completion

March 6, 2019

Study Completion

March 6, 2019

Last Updated

November 3, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations