Maximizing the Dietary Pattern of Older Adults: the Effects of Protein Intake on Protein Kinetics

Study Overview
=================
Brief Summary
-----------------
A randomized study to demonstrate how animal-based protein-rich food sources can be used by older adults to increase protein intake within pre-existing dietary patterns.

Detailed Description
-----------------
Current dietary patterns of older Americans will be augmented by readily available quality protein sources. Investigators will observe the effects of recommended and common protein intakes on the maintenance of whole-body protein balance and potential for muscle protein anabolism. 3 groups of 10 older subjects will be studied during daily protein intakes. Study duration per subject will be about 2 weeks.

Official Title
-----------------
Maximizing the Dietary Pattern of Older Adults: the Effects of Protein Intake on Protein Kinetics

Conditions
-----------------
Sarcopenia

Intervention / Treatment
-----------------
* Other: Recommended Dietary Allowance of Protein
* Other: Habitual protein intake
* Other: Optimal Protein Intake


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI ≤ 35 kg/m2 Capable of providing informed consent COVID-19 negative and/or asymptomatic Exclusion Criteria: Subject who does not/will not eat animal protein sources. Body mass index > 35. History of chemotherapy or radiation therapy for cancer in the 6 months prior to enrollment. Use of insulin to control blood sugar level. Currently receiving androgen (e.g., testosterone) or anabolic (e.g., GH, IGF-I) therapy. Currently using prescription blood thinning medications. Unable or unwilling to suspend aspirin use for 7 days prior to Visit 3. Unwilling to avoid using protein or amino-acid supplements during participation.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Recommended dietary allowance (RDA) for protein<br>(RDA; 0.8g/kg/day) Protein intakes will be structured within two meals per day. A 2-day dietary lead-in will precede each dietary intervention. Study duration per subject will last about two weeks. | Other: Recommended Dietary Allowance of Protein<br>* 0.8 g/kg/day protein intake<br>* Other names: RDA;|
| Experimental: Habitual protein intake consistent with population level norms<br>(NHANES; 1.0g/kg/day) Protein intakes will be structured within two meals per day. A 2-day dietary lead-in will precede each dietary intervention. Study duration per subject will last about two weeks. | Other: Habitual protein intake<br>* 1.0 g/kg/day protein intake<br>* Other names: NHANES;|
| Experimental: Optimal protein intake (OPI)<br>(OPI; 1.5g/kg/day) Protein intakes will be structured within two meals per day. A 2-day dietary lead-in will precede each dietary intervention. Study duration per subject will last about two weeks. | Other: Optimal Protein Intake<br>* 1.5 g/kg/day protein intake<br>* Other names: OPI;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Whole Body Protein Turnover | Isotope Tracer | 24 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
muscle loss, protein, animal-based protein