Role of Dietary Protein Intake in Elderly Adults

NCT03765710 | Completed

• 1 other identifier: 204291
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Protein Overload

Outcome Measures

Primary Outcomes (2)

• Changes in whole body anabolism

  Whole body net protein balance in gram protein

  Change before and after a mixed meal intake for approximately 8 hours

• Changes in skeletal muscle synthetic rate

  Skeletal muscle fractional synthetic rate in % synthesis

  Change before and after a mixed meal intake for approximately 8 hours

Study Arms (2)

Recommended protein intake

EXPERIMENTAL

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

Other: Recommended protein intake

Elevated protein intake

EXPERIMENTAL

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

Other: Elevated protein intake

Interventions

Recommended protein intake OTHER

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

Recommended protein intake

Elevated protein intake OTHER

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

Elevated protein intake

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women, ages \> 60 years

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arkansas: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2018
• First Posted: December 5, 2018
• Study Start: August 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: April 26, 2023

Record last verified: 2018-12