Effect of Dietary Protein Intake Distribution on Protein Metabolism and Skeletal Muscle
1 other identifier
interventional
19
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2014
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
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 12, 2016
CompletedFirst Posted
Study publicly available on registry
June 1, 2016
CompletedJune 1, 2016
May 1, 2016
1.3 years
May 12, 2016
May 26, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in net protein synthesis rate
Change from Baseline to 8 weeks
Study Arms (2)
Uneven Protein Intake Pattern
EXPERIMENTALSubjects 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.
Even Protein Intake Pattern
EXPERIMENTALSubjects 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
Interventions
Each participant will consume 15%/2-%/65% of total protein in breakfast, lunch, and dinner, respectively)\] on net protein synthesis over 8 weeks.
Each participant will consume 33% of total protein consumed each meal
Eligibility Criteria
You may qualify if:
- Men and women, ages 50-70 years
- BMI between 24 and 30 kg/m2
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 28318687DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Arny A Ferrando, Ph.D.
University of Arkansas
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2016
First Posted
June 1, 2016
Study Start
January 1, 2014
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
June 1, 2016
Record last verified: 2016-05