Beef versus plant protein for improving muscle-building responses in (pre)frail older adults
Anabolic Response to Beef vs Plant Protein in (Pre)Frail Older Adults Using a Novel Stable Isotope Pulse Method
This study will test whether a beef meal, a tofu meal, or a placebo produces a stronger muscle-building response in adults aged 65–95 with (pre)frailty.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 65 Years to 95 Years |
| Sex | All |
| Sponsor | Texas A&M University Academic / other |
| Locations | 1 site (College Station, Texas) |
| Trial ID | NCT07254403 on ClinicalTrials.gov |
What this trial studies
Researchers will compare the acute anabolic response to meals made from beef, tofu, or placebo in adults 65–95 identified as (pre)frail, using a novel stable isotope amino acid pulse method to measure intracellular amino acid bioavailability. Participants will attend a screening visit and four study days at Texas A&M, arriving fasted for each test day while body composition, muscle function, and blood samples are collected over several hours with participants lying supine. The protocol includes DXA for body composition, a six-minute walk test, and controlled meal challenges with measurement of essential and nonessential amino acid appearance and incorporation into muscle. Results will show whether beef provides a more favorable amino acid profile and anabolic response than plant protein in this population.
Who should consider this trial
Good fit: Ideal candidates are ambulatory adults aged 65–95 with (pre)frailty who can fast for test days, lie supine for up to six hours, and are not taking medications or supplements that affect protein metabolism.
Not a fit: People with advanced chronic diseases (insulin-dependent diabetes, active cancer, significant heart, liver, or kidney disease), dementia, extreme BMI (<17 or >35), or inability to travel to Texas A&M are unlikely to benefit from or be eligible for this protocol.
Why it matters
Potential benefit: If successful, the findings could help clinicians and older adults choose protein sources that better preserve muscle mass and physical function during (pre)frailty.
How similar studies have performed: Prior research shows animal proteins generally produce greater acute anabolic responses than many plant proteins, but applying a novel stable isotope pulse method in (pre)frail older adults is relatively new.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
College Station, Texas
- Texas A&M University — College Station, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Marielle Engelen — Texas A&M University
- Study coordinator: Marielle Engelen, PhD
- Email: mpkj.engelen@ctral.org
- Phone: 9792202282
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.