NCT04121689

Brief Summary

The anabolic action of 'fast' whey protein on the regulation of postprandial muscle protein synthesis has been established to be short-lived in healthy young adults. Our aim was assess the time course of anabolic signaling events and stimulation of muscle protein synthesis rates (MPS) after ingestion of a food source that represents a more typical meal-induced pattern of aminoacidemia, namely milk protein concentrate, in healthy young males.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2014

Longer than P75 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

October 1, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
4.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 26, 2019

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 3, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 10, 2019

Completed
Last Updated

October 10, 2019

Status Verified

August 1, 2019

Enrollment Period

1 month

First QC Date

September 3, 2019

Last Update Submit

October 7, 2019

Conditions

Keywords

ProteinAmino AcidsAnabolic SignalingMuscle Mass

Outcome Measures

Primary Outcomes (1)

  • Fractional synthesis rates of myofibrillar protein

    Myofibrillar protein synthesis rates will be assessed during the postabsorptive period for 3 hours, and every 1-2 hours during the 5 hours after protein ingestion. This will allow us assess the timecourse of muscle protein synthesis after eating.

    8 hours

Secondary Outcomes (2)

  • Phosphorylation of muscle anabolic signaling

    8 hours

  • Exogenous rate of phenylalanine appearance

    5 hours

Study Arms (1)

Milk Protein Concentrate

EXPERIMENTAL

Seven young men (age: 22±1 y) will undergo repeated blood and biopsy sampling during primed continuous L-\[ring-2H5\]phenylalanine and L-\[1-13C\]leucine tracer infusions, and ingested 38 g of L-\[1-13C\]phenylalanine- and L-\[1-13C\]leucine-labeled milk protein concentrate

Dietary Supplement: Milk Protein Concentrate

Interventions

Milk Protein ConcentrateDIETARY_SUPPLEMENT

The macronutrient composition and energy of the milk protein beverage provided to participants is 38 g protein (3.46 g leucine), 4.17 g carbohydrate, and 1.4 g fat. The milk protein met all chemical and bacteriologic specifications for human consumption. The L-\[1-13C\]phenylalanine and L-\[1-13C\]leucine enrichments in the milk protein concentrate averaged 38.3 and 10.8 mole percent excess (MPE), respectively.

Milk Protein Concentrate

Eligibility Criteria

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

You may qualify if:

  • Males
  • Aged between 18-35 years
  • Healthy, recreationally active
  • BMI \< 30 kg/m2

You may not qualify if:

  • Smoking
  • Allergies to milk proteins
  • Vegetarians
  • Diagnosed GI tract diseases
  • Female
  • Arthritic conditions
  • A history of neuromuscular problems
  • Previous participation in amino acid tracer studies
  • Predisposition to hypertrophic scarring or keloid formation
  • Individuals on any medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories, or prescription strength acne medications).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Freer Hall

Urbana, Illinois, 61801, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2019

First Posted

October 10, 2019

Study Start

October 1, 2014

Primary Completion

November 1, 2014

Study Completion

August 26, 2019

Last Updated

October 10, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations