NCT07254403 · Texas A&M University
Anabolic Response to Beef vs Plant Protein in (Pre)Frail Older Adults Using a Novel Stable Isotope Pulse Method
What this study is about
Frailty is a common clinical syndrome in older adults that increases the risk for poor health outcomes including falls, disability, hospitalization, and mortality.
View original scientific description
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.
Interventions
OTHER
Beef
Beef, ground, 93% lean meat / 7% fat, patty, cooked, broiled: 100g = 26.2 g protein
OTHER
Tofu
Fried tofu: 100g = 18.8 g protein
OTHER
Placebo
water (to correct the anabolic data obtained after intake of the proteins for baseline (postabsorptive) values
Primary outcome measures
Protein and amino acid synthesis capacity of beef and soy protein in older adults measured by the use of stable isotope tracers
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age 65-95 years old
- Ability to walk, sit down, and stand up (independently or with walking assistance device)
- No recent use (\< 4 weeks prior to start of the study) of dietary supplements and medication influencing protein and amino acid metabolism (e.g., antibiotics, oral corticosteroids)
- Willingness to lay supine in bed for up to 6 hours
- Willingness and ability to comply with the protocol
Exclusion criteria
- Presence of malnutrition (BMI \< 17 kg/m2), 2). BMI \>35 kg/m2 to avoid weight-related metabolic disturbances,
- Established diagnosis and active treatment of chronic disease: Insulin-dependent diabetes mellitus, active malignancy, heart disease, kidney disease, liver disease, HIV/AIDS, Asthma (moderate to severe), Hep (A, B, or C)
- History of untreated metabolic disease including hepatic or renal disorder
- Presence of fever within the last 3 days
- Cirrhosis of liver
- Diagnosis of dementia, neurodegenerative disease (e.g., Alzheimer's disease, Parkinson's disease, Huntington's chorea, frontotemporal dementia).
- (Possible) pregnancy
- Presence of acute illness or metabolically unstable chronic illness
- Active dependence on alcohol or drugs
- Newly prescribed long-term oral corticosteroids
- Planned elective surgery requiring 2 or more days of hospitalization during the entire study
- Failure to give informed consent or Investigator's uncertainty about the willingness or ability of the subject
- Already enrolled in another clinical trial
- Any condition according to the PI or nurse that was found during the screening visit, that would interfere with the study or safety of the patient
- Known allergy to any of the components of the feeding (soy, beef)
- Established daily diet of vegetarian/vegan composition
Where
- College Station, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 28, 2025 · Source of record for eligibility and locations