Anabolic Response to Beef vs Plant Protein in (Pre)Frail Older Adults Using a Novel Stable Isotope Pulse Method

NCT07254403 | Recruiting

• 1 other identifier: 107-Beef
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  6 weeks

Study Arms (3)

Frail older adults

EXPERIMENTAL

based on the Fried index

Other: Beef; Other: Tofu; Other: Placebo

Pre-Frail Older Adults

EXPERIMENTAL

based on the Fried index

Other: Beef; Other: Tofu; Other: Placebo

Non-Frail Older Adults

EXPERIMENTAL

based on the Fried index

Other: Beef; Other: Tofu; Other: Placebo

Interventions

Beef OTHER

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

Frail older adults; Non-Frail Older Adults; Pre-Frail Older Adults

Tofu OTHER

Fried tofu: 100g = 18.8 g protein

Frail older adults; Non-Frail Older Adults; Pre-Frail Older Adults

Placebo OTHER

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

Frail older adults; Non-Frail Older Adults; Pre-Frail Older Adults

Eligibility Criteria

• Age: 65 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Texas A&M University: lead

Study Sites (1)

Texas A&M University

College Station, Texas, 77843, United States

RECRUITING

MeSH Terms

Interventions

Red Meat; Soy Foods

Intervention Hierarchy (Ancestors)

Meat; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Fermented Foods; Vegetable Products; Vegetables

Study Officials

• Marielle Engelen

  Texas A&M University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marielle Engelen, PhD

CONTACT

9792202282; mpkj.engelen@ctral.org

Laura Ruebush, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: November 28, 2025
• Study Start: October 31, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)