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
About this trial
This is an interventional basic science trial for Sarcopenia
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
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
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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