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Manipulation of Dietary Protein and the Anabolic Response (PRO-ADAPT)

Primary Purpose

Focus: Anabolic Response to Food Intake in Young Individuals, Condition Relevance: Skeletal Muscle Health, Sarcopenia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
High protein intake
Placebo comparator
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Focus: Anabolic Response to Food Intake in Young Individuals focused on measuring Muscle protein synthesis, Dietary protein

Eligibility Criteria

18 Years - 35 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    High protein intake

    No protein intake

    Arm Description

    High protein intake: large bolus of protein in teh diet the day before testing

    No protein in the diet the day before testing

    Outcomes

    Primary Outcome Measures

    Muscle protein fractional synthetic rate following protein ingestion
    The ability of the muscle to synthesise new proteins will be assessed over a 3 h period following protein ingestion and will be compared between groups. This only occurs on one occasion.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 18, 2013
    Last Updated
    March 21, 2017
    Sponsor
    Maastricht University Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01820975
    Brief Title
    Manipulation of Dietary Protein and the Anabolic Response
    Acronym
    PRO-ADAPT
    Official Title
    The Manipulation of Dietary Protein Intake on the Anabolic Response in Healthy Young Men
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2013 (undefined)
    Primary Completion Date
    March 2015 (Actual)
    Study Completion Date
    February 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Maastricht University Medical Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    In the present study, the effect of habitual dietary protein on the anabolic response will be investigated.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Focus: Anabolic Response to Food Intake in Young Individuals, Condition Relevance: Skeletal Muscle Health, Sarcopenia
    Keywords
    Muscle protein synthesis, Dietary protein

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    28 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    High protein intake
    Arm Type
    Experimental
    Arm Description
    High protein intake: large bolus of protein in teh diet the day before testing
    Arm Title
    No protein intake
    Arm Type
    Placebo Comparator
    Arm Description
    No protein in the diet the day before testing
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    High protein intake
    Intervention Type
    Other
    Intervention Name(s)
    Placebo comparator
    Other Intervention Name(s)
    control group
    Intervention Description
    No protein intake
    Primary Outcome Measure Information:
    Title
    Muscle protein fractional synthetic rate following protein ingestion
    Description
    The ability of the muscle to synthesise new proteins will be assessed over a 3 h period following protein ingestion and will be compared between groups. This only occurs on one occasion.
    Time Frame
    3 hours

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Males Aged between 18-35 years Healthy, recreationally active BMI < 30 kg/m2 Exclusion Criteria: Smoking Allergies to milk proteins (whey or casein) Vegetarians Diagnosed GI tract diseases Female Arthritic conditions A history of neuromuscular problems Previous participation in amino acid tracer studies Individuals on any medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories, or prescription strength acne medications
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Luc JC van Loon, PhD
    Organizational Affiliation
    Maastricht University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    32069356
    Citation
    Gorissen SHM, Trommelen J, Kouw IWK, Holwerda AM, Pennings B, Groen BBL, Wall BT, Churchward-Venne TA, Horstman AMH, Koopman R, Burd NA, Fuchs CJ, Dirks ML, Res PT, Senden JMG, Steijns JMJM, de Groot LCPGM, Verdijk LB, van Loon LJC. Protein Type, Protein Dose, and Age Modulate Dietary Protein Digestion and Phenylalanine Absorption Kinetics and Plasma Phenylalanine Availability in Humans. J Nutr. 2020 Aug 1;150(8):2041-2050. doi: 10.1093/jn/nxaa024.
    Results Reference
    derived

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    Manipulation of Dietary Protein and the Anabolic Response

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