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Effect of Dietary Protein Intake Distribution on Protein Metabolism and Skeletal Muscle

Primary Purpose

Sarcopenia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Uneven Protein intake pattern
Even Protein Intake Pattern
Sponsored by
University of Arkansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Sarcopenia

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Men and women, ages 50-70 years
  • BMI between 24 and 30 kg/m2

Exclusion Criteria:

  • Current diagnosis of diabetes
  • History of malignancy in the 6 months prior to enrollment
  • History of lactose intolerance or dairy allergy
  • History of egg allergy or intolerance
  • History of gastrointestinal bypass surgery.
  • History of a chronic inflammatory condition or other chronic disease (Lupus, HIV/AIDS, etc)
  • Subjects who do not or will not eat animal proteins
  • Subjects who cannot refrain from consuming protein or amino acid supplements during their participation in this study
  • Subjects who report regular resistance exercise (more than twice per week)
  • Hemoglobin less than 9.5 mg/dL at the screening visit
  • Platelets less than 150,000 at the screening visit
  • Concomitant use of corticosteroids (ingestion, injection or transdermal)
  • Any other disease or condition that would place the subject at increased risk of harm if they were to participate, at the discretion of the study physician

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Uneven Protein Intake Pattern

    Even Protein Intake Pattern

    Arm Description

    Subjects consumed either dietary protein intake at 1.1g protein/kg/day over 8 weeks.Each participant will consume 15%/2-%/65% of total protein in breakfast, lunch, and dinner, respectively)] on net protein synthesis over 8 weeks.

    Subjects consumed either dietary protein intake at 1.1g protein/kg/day over 8 weeks. Each participant will consume 33% of total protein consumed each meal

    Outcomes

    Primary Outcome Measures

    Changes in net protein synthesis rate

    Secondary Outcome Measures

    Full Information

    First Posted
    May 12, 2016
    Last Updated
    May 26, 2016
    Sponsor
    University of Arkansas
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02787889
    Brief Title
    Effect of Dietary Protein Intake Distribution on Protein Metabolism and Skeletal Muscle
    Official Title
    Effect of Dietary Protein Intake Distribution on Protein Metabolism and Skeletal Muscle
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2014 (undefined)
    Primary Completion Date
    May 2015 (Actual)
    Study Completion Date
    May 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Arkansas

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The investigators determined effects of 8-week dietary protein intake in mixed meals with uneven or even consumption pattern on the metabolic outcomes of whole-body net protein synthesis and muscle protein synthesis in older participants.
    Detailed Description
    The demonstrated benefits of increased protein intake on sarcopenia and many physiological functions is becoming increasingly evident. For this reason, there is growing importance to ensuring that Americans consume the recommended amount of protein, calculated to be 17-21% of caloric intake. As it relates to the prevention of sarcopenia, adequate protein consumption inherently assumes that sufficient protein is ingested to stimulate protein anabolism. Specifically, adequate essential amino acid precursors, and anabolic triggers such as leucine, must be present for protein anabolism to occur. Population data from the NHANES study suggests that American protein intake pattern is skewed towards the evening meal. The NHANES data also suggests that the average protein consumption of both men and women over the age of 50 yrs is approximately 1.1 g/kg/d. Thus, the prevalent consumption pattern ensures that many individuals consume adequate protein, or amino acid precursors sufficient to stimulate protein synthesis, only with the larger, or dinner meal. The investigators have demonstrated that frequent stimulation of protein synthesis with amino acids preserves strength and function. Others have demonstrated that adequate protein intake stimulates muscle protein synthesis and increases lean mass. Given these data, The investigators studied the effects of two different protein intake patterns on metabolic and functional outcomes in older individuals after 8 wks of dietary control. The mean protein intake for this group of 1.1 g/kg/d was consumed in two distinct meal patterns. Participants consumed high quality protein in the ratio of 15/20/65% of total protein intake for breakfast/lunch/dinner, respectively (Uneven protein intake pattern), or protein consumption was distributed equally among each meal (33% of total protein)(Even protein intake pattern). The investigators determined the longitudinal effects of this consumption pattern on the metabolic outcomes of whole-body net protein synthesis and muscle protein synthesis in older participants.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sarcopenia

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    19 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Uneven Protein Intake Pattern
    Arm Type
    Experimental
    Arm Description
    Subjects consumed either dietary protein intake at 1.1g protein/kg/day over 8 weeks.Each participant will consume 15%/2-%/65% of total protein in breakfast, lunch, and dinner, respectively)] on net protein synthesis over 8 weeks.
    Arm Title
    Even Protein Intake Pattern
    Arm Type
    Experimental
    Arm Description
    Subjects consumed either dietary protein intake at 1.1g protein/kg/day over 8 weeks. Each participant will consume 33% of total protein consumed each meal
    Intervention Type
    Other
    Intervention Name(s)
    Uneven Protein intake pattern
    Intervention Description
    Each participant will consume 15%/2-%/65% of total protein in breakfast, lunch, and dinner, respectively)] on net protein synthesis over 8 weeks.
    Intervention Type
    Other
    Intervention Name(s)
    Even Protein Intake Pattern
    Intervention Description
    Each participant will consume 33% of total protein consumed each meal
    Primary Outcome Measure Information:
    Title
    Changes in net protein synthesis rate
    Time Frame
    Change from Baseline to 8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Men and women, ages 50-70 years BMI between 24 and 30 kg/m2 Exclusion Criteria: Current diagnosis of diabetes History of malignancy in the 6 months prior to enrollment History of lactose intolerance or dairy allergy History of egg allergy or intolerance History of gastrointestinal bypass surgery. History of a chronic inflammatory condition or other chronic disease (Lupus, HIV/AIDS, etc) Subjects who do not or will not eat animal proteins Subjects who cannot refrain from consuming protein or amino acid supplements during their participation in this study Subjects who report regular resistance exercise (more than twice per week) Hemoglobin less than 9.5 mg/dL at the screening visit Platelets less than 150,000 at the screening visit Concomitant use of corticosteroids (ingestion, injection or transdermal) Any other disease or condition that would place the subject at increased risk of harm if they were to participate, at the discretion of the study physician
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Arny A Ferrando, Ph.D.
    Organizational Affiliation
    University of Arkansas
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    28318687
    Citation
    Kim IY, Schutzler S, Schrader AM, Spencer HJ, Azhar G, Wolfe RR, Ferrando AA. Protein intake distribution pattern does not affect anabolic response, lean body mass, muscle strength or function over 8 weeks in older adults: A randomized-controlled trial. Clin Nutr. 2018 Apr;37(2):488-493. doi: 10.1016/j.clnu.2017.02.020. Epub 2017 Mar 3.
    Results Reference
    derived

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    Effect of Dietary Protein Intake Distribution on Protein Metabolism and Skeletal Muscle

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