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

Sarcopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02787889
• Other study ID #: 139057
• Status: Completed
• Phase: N/A
• First received: May 12, 2016
• Last updated: May 26, 2016
• Start date: January 2014
• Est. completion date: May 2015

Study information

• Verified date: May 2016
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Sarcopenia

Intervention

Other:
• Uneven Protein intake pattern
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
Each participant will consume 33% of total protein consumed each meal

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in net protein synthesis rate		Change from Baseline to 8 weeks	No