Recruiting

Protein Response

Sponsor:

Texas A&M University

Code:

NCT07254403

Conditions

Protein Metabolism

Eligibility Criteria

Sex: All

Age: 65 - 70+

Healthy Volunteers: Accepted

Interventions

Beef

Tofu

Placebo

Study Details

Brief 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 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.

Conditions

Protein Metabolism

Study ID

NCT07254403

Start date

Oct 31, 2025

Status verified date

Nov, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Frail older adults

based on the Fried index

experimental: Pre-Frail Older Adults

based on the Fried index

experimental: Non-Frail Older Adults

based on the Fried index

Interventions

Beef

Beef, ground, 93% lean meat / 7% fat, patty, cooked, broiled: 100g = 26.2 g protein

Tofu

Fried tofu: 100g = 18.8 g protein

Placebo

water (to correct the anabolic data obtained after intake of the proteins for baseline (postabsorptive) values

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 ]

Central Contacts and Locations

Central contacts

Marielle Engelen, PhD

9792202282mpkj.engelen@ctral.org

Laura Ruebush, PhD

979-458-1484le.ruebush@ctral.org

Locations

Texas A&M University

Recruiting

College Station, Texas, United States, 77843

Contacts

Marielle P Engelen, PhD

979-220-2282mpkj.engelen@ctral.org

More Information

Sponsor

Texas A&M University

Last update posted

Nov 28, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-29. This information was provided to ClinicalTrials.gov by Texas A&M University on 2025-11-28. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.