Texas A&M University
College Station, Texas, 77843, United States
Location status: Recruiting
NCT Number: NCT07254403
Frailty is a common clinical syndrome in older adults that increases the risk for poor health outcomes including falls, disability, hospitalization, and mortality. Previous research showed increased protein needs and reduced anabolic response to meals in older adults, indicating the need for proteins with a high anabolic capacity to prevent and attenuate physical and cognitive health decline throughout the frailty cycle. Recently, more people have chosen to eliminate animal (i.e., beef) products from their diets which is concerning because of beef's anabolic properties due to high essential amino acid (EAA) levels and many other positive health effects. The Researchers' recently developed stable isotope amino acid pulse method enables measurement of the true intracellular anabolic response to a meal and bioavailability of food-derived amino acids. The research objective is to examine differences in the anabolic response and bioavailability of individual EAA and non-essential amino acids (NEAA) in beef as compared to plant protein in older adults with and without (pre-)frailty.
Interested in participating?
Request Info65 year–95 year
All sexes
Interventional
Not applicable
College Station, Texas, 77843, United States
Location status: Recruiting
Beef protein is known for its anabolic properties due to its high EAA levels and digestibility (~ 94% compared to 78% in beans and 86% in whole wheat). However, whether beef has the most optimal composition of individual EAA and non-essential amino acids (NEAA) for older adults with (pre)frailty remains unclear as well as the role of the individual branched-chain amino acids (BCAA) leucine, isoleucine and valine. Research is of scientific and clinical importance to understand whether (pre)frail older adults respond better to certain protein sources (i.e., beef protein) due to a more optimal profile/pattern of individual EAA and NEAA amino acids.
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 bites and sips of nutrition every 20 minutes for 5 hours. Participants will consume, using a randomized cross-over design, using a bite feeding method of the following proteins: (1) beef, (2) tofu (soy as the most popular plant-based protein) or (3) water (placebo to correct the anabolic data obtained after intake of the proteins for baseline (postabsorptive) values).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Beef, ground, 93% lean meat / 7% fat, patty, cooked, broiled: 100g = 26.2 g protein
Fried tofu: 100g = 18.8 g protein
water (to correct the anabolic data obtained after intake of the proteins for baseline (postabsorptive) values
Time frame: 6 weeks
A novel stable isotope technique will be used to assess simultaneously the anabolic response and whole body production rates of a variety of amino acids to intake of both dietary proteins 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.
Contact information is provided by the study sponsor or research team.
Laura Ruebush, PhD
CONTACT
Marielle Engelen, PhD
CONTACT
Texas A&M University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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