Role of Dietary Protein Intake in Elderly Adults

NCT ID: NCT03765710

Last Updated: 2023-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2016-09-30

Brief Summary

The investigators examined the effects of dietary protein intake in a mixed meal at two levels of protein amount on whole body protein metabolisms in older adults.

Detailed Description

The investigators determined the total anabolic response to an amount of protein intake commonly eaten with dinner (70g) as compared with the amount required to maximally stimulate muscle protein synthesis (35g). Men and women, ages > 60 years will be studied under two levels of protein intake in mixed meals in random order (35g or 70g protein in isocaloric mixed meals). For two days prior to each stable isotope tracer study, subjects' dietary intake of calories and protein will be stabilized by providing subjects their entire diets. On the third day, a 8-hr metabolic study will be conducted in the UAMS Reynolds Institute on Aging (IOA) to determine the total anabolic response to the particular amount of beef intake, which will be repeated with the other amount of protein in mixed meal after a minimum 7-day washout interval. The investigators measured whole body protein kinetics, muscle fractional synthetic rate, and plasma amino acid profile.

Conditions

Protein Overload

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Recommended protein intake

Subjects consumed a mixed meal with a macronutrient distribution of 13% protein, 54% carbohydrate, and 33% fat.

Group Type: EXPERIMENTAL

Recommended protein intake

Intervention Type: OTHER

Recommended protein intake in a mixed meal contained 13% protein, 54% carbohydrate, and 33% fat.

Elevated protein intake

Subjects consumed a mixed meal with a macronutrient distribution of 26% protein, 44% carbohydrate, and 30% fat.

Group Type: EXPERIMENTAL

Elevated protein intake

Intervention Type: OTHER

Increased protein intake in a mixed meal contained 26% protein, 44% carbohydrate, and 30% fat.

Interventions

Recommended protein intake

Recommended protein intake in a mixed meal contained 13% protein, 54% carbohydrate, and 33% fat.

Intervention Type: OTHER

Elevated protein intake

Increased protein intake in a mixed meal contained 26% protein, 44% carbohydrate, and 30% fat.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Men and women, ages > 60 years

Exclusion Criteria

• History of diabetes
• History of malignancy in the 6 months prior to enrollment
• History of gastrointestinal bypass surgery (Lapband, etc)
• History of a chronic inflammatory condition or disease (Lupus, HIV/AIDS, etc)
• Pregnant females
• 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 once per week)
• Hemoglobin less than 9.5 mg/dL at the screening visit
• Platelets less than 150,000 at the screening visit
• Subjects who are not willing or able to suspend aspirin for several days prior to their muscle biopsies
• Subjects who have been prescribed a blood-thinning medication (Coumadin, lovenox, heparin, Plavix, etc.)
• 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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Arkansas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

204291

Identifier Type: -

Identifier Source: org_study_id