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Recruiting NCT07254403

NCT07254403 Anabolic Response to Beef vs Plant Protein in (Pre)Frail Older Adults Using a Novel Stable Isotope Pulse Method

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Clinical Trial Summary
NCT ID NCT07254403
Status Recruiting
Phase
Sponsor Texas A&M University
Condition Protein Metabolism
Study Type INTERVENTIONAL
Enrollment 60 participants
Start Date 2025-10-31
Primary Completion 2026-12

Eligibility & Interventions

Sex All sexes
Min Age 65 Years
Max Age 95 Years
Study Type INTERVENTIONAL
Interventions
BeefTofuPlacebo

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 60 participants in total. It began in 2025-10-31 with a primary completion date of 2026-12.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

Eligibility 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

Contact & Investigator

Central Contact

Marielle Engelen, PhD

✉ mpkj.engelen@ctral.org

📞 9792202282

Principal Investigator

Marielle Engelen

PRINCIPAL INVESTIGATOR

Texas A&M University

Frequently Asked Questions

Who can join the NCT07254403 clinical trial?

This trial is open to participants of all sexes, aged 65 Years or older, up to 95 Years, studying Protein Metabolism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07254403 currently recruiting?

Yes, NCT07254403 is actively recruiting participants. Contact the research team at mpkj.engelen@ctral.org for enrollment information.

Where is the NCT07254403 trial being conducted?

This trial is being conducted at College Station, United States.

Who is sponsoring the NCT07254403 clinical trial?

NCT07254403 is sponsored by Texas A&M University. The principal investigator is Marielle Engelen at Texas A&M University. The trial plans to enroll 60 participants.

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