Protein MetabolismNCT07254403
Anabolic Response to Beef vs Plant Protein in (Pre)Frail Older Adults Using a Novel Stable Isotope Pulse Method
A study testing Beef and Tofu in people with Protein Metabolism, run by Texas A&M University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 65 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Protein Metabolism
- What is being tested?
- Beef and Tofu
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 95 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Show all 16Show fewer
- (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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Texas A&M University
College Station, Texas, 77843
Marielle P Engelen, PhD, 979-220-2282, mpkj.engelen@ctral.org
About this study
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.
Read the detailed description
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).
- Conditions
- Protein Metabolism
- Being tested
- Beef, Tofu, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BeefOther
Beef, ground, 93% lean meat / 7% fat, patty, cooked, broiled: 100g = 26.2 g protein
TofuOther
Fried tofu: 100g = 18.8 g protein
PlaceboOther
water (to correct the anabolic data obtained after intake of the proteins for baseline (postabsorptive) values
| Study group | Role | What they receive |
|---|---|---|
| Frail older adults | Experimental | based on the Fried index Receives: Other: Beef; Other: Tofu; Other: Placebo |
| Pre-Frail Older Adults | Experimental | based on the Fried index Receives: Other: Beef; Other: Tofu; Other: Placebo |
| Non-Frail Older Adults | Experimental | based on the Fried index Receives: Other: Beef; Other: Tofu; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protein and amino acid synthesis capacity of beef and soy protein in older adults measured by the use of stable isotope tracers
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start31 Oct 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Protein MetabolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas A&M University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marielle PKJ Engelen, PhD, Texas A&M University
- Investigators
- Marielle Engelen, Principal investigator, Texas A&M University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07254403
- Sponsor's protocol ID
- 107-Beef
- Status last verified
- Nov 2025
- First submitted
- 19 Nov 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anabolic Response to Beef vs Plant Protein in (Pre)Frail Older Adults Using a Novel Stable Isotope Pulse Method
- ClinicalTrials.gov ID
- NCT07254403
- Acronym / sponsor ID
- 107-Beef
- Conditions
- Protein Metabolism
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Study start
- 31 Oct 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 28 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Frail older adults | Experimental | Other: Beef, Other: Tofu, Other: Placebobased on the Fried index |
| Pre-Frail Older Adults | Experimental | Other: Beef, Other: Tofu, Other: Placebobased on the Fried index |
| Non-Frail Older Adults | Experimental | Other: Beef, Other: Tofu, Other: Placebobased on the Fried index |
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BeefBeef, ground, 93% lean meat / 7% fat, patty, cooked, broiled: 100g = 26.2 g protein | Other | Frail older adults, Non-Frail Older Adults, Pre-Frail Older Adults |
| TofuFried tofu: 100g = 18.8 g protein | Other | Frail older adults, Non-Frail Older Adults, Pre-Frail Older Adults |
| Placebowater (to correct the anabolic data obtained after intake of the proteins for baseline (postabsorptive) values | Other | Frail older adults, Non-Frail Older Adults, Pre-Frail Older Adults |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marielle Engelen principal investigator
Texas A&M University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beef and Tofu in people with Protein Metabolism, run by Texas A&M University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marielle Engelen, PhD (9792202282, mpkj.engelen@ctral.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.