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Clinical Trials/NCT06693544
NCT06693544
Enrolling By Invitation
Not Applicable

Comparing Intracellular Anabolic Capacity and Food-derived Amino Acid Bioavailability of Peanut and Dairy Protein in Healthy Non-frail Older Adults at Risk for (Pre)Frailty

Texas A&M University1 site in 1 country15 target enrollmentStarted: October 23, 2024Last updated:

Overview

Phase
Not Applicable
Status
Enrolling By Invitation
Enrollment
15
Locations
1
Primary Endpoint
Protein synthesis capacity of plant-based in older adults without sarcopenia measured by the use of stable isotope tracers

Overview

Brief Summary

Peanuts are considered a functional food and regular consumption is associated with positive health effects. Protein is the second most common nutrient in peanuts after fat. The protein digestibility of peanuts is similar to that of animal protein, and the limiting amino acids in peanuts vary based on the study and are suggested to be lysine, methionine, or threonine. Defining the reduced responsiveness of various dietary proteins to induce anabolism in older adults is critical for preventing and attenuating physical and cognitive health decline.

Detailed Description

The study will be conducted in healthy, non-frail older adults, stratified into different age categories. A sip feeding model will be used as it is a good model to establish the anabolic capacity of meals.Our research objective is to examine whether differences exist in the anabolic response and bioavailability of amino acids coming from peanut-based protein as compared to animal-based protein in older adults at risk for (pre-)frailty, known to contribute to poor muscle and brain health. The study will take place at the research facility of the Center for Translational Research on Aging and Longevity (CTRAL), Texas A&M University located in the Human Clinical Research Building ) affiliated with Texas A&M University. The study involves 1 screening visit of approx. 3 hours, and 4 study days. Some study procedures (e.g., body composition, skeletal muscle function, questionnaires) may be skipped if completed within the past 3 months at CTRAL. All data will be recorded in Case Report Form and stored in the Texas A&M REDCap System. Subjects will be asked to arrive in the fasted state on all study days. Fasting prior to screening is not required. On the screening day, body weight, height, and body composition by Dual-energy X-ray absorptiometry (DXA) will be measured. In addition, The Six-Minute Walk Test (6MWT) and skeletal muscle function tests will be assessed at the end of each screening visit. Each study visit will begin with vital signs. Before administration of the feeding or the tracer solution, baseline blood will be collected for measurement of the natural enrichment of metabolites. After the baseline sample is collected, feeding will begin and will be followed by tracers of several compounds that may be administered by IV pulse. Participants will receive the liquid nutritional supplement as sip feeds every 20 minutes for 5 hours. The liquid nutrition supplements will contain 45g of peanut protein (plant based). Comparison of results from meals taken while enrolled in NCTNCT06628349 will be performed. Participants will have the option of adding sugar free (SF) vanilla syrup, SF caramel syrup, or SF chocolate syrup to their meals.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
65 Years to 80 Years (Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Protein synthesis capacity of plant-based in older adults without sarcopenia measured by the use of stable isotope tracers

Time Frame: 2 weeks

A novel stable isotope technique will be used to assess simultaneously the anabolic response and whole-body production rates of protein synthesis when taking oral nutrition in sarcopenic older participants. The samples will be stored in laboratory freezers and the amino acid isotope enrichments and concentrations analyzed by Liquid Chromatography with tandem mass spectrometry (LC-MS/MS). The researchers will then conduct LC-MS/MS analysis, peak integration, calculation of amino acid concentrations and whole body productions from raw data, and use the results for preparation of papers for presentation, publication, and final reports. The researchers main hypothesis is that plant-based protein induces less protein anabolism, due to lower whole body production of essential amino acids (EAA) and higher production of non-essential amino acids (NEAA).

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Marielle PKJ Engelen, PhD

Professor

Texas A&M University

Study Sites (1)

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