- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07254403
Anabolic Response to Beef vs Plant Protein in (Pre)Frail Older Adults Using a Novel Stable Isotope Pulse Method
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Marielle Engelen, PhD
- Phone Number: 9792202282
- Email: mpkj.engelen@ctral.org
Study Contact Backup
- Name: Laura Ruebush, PhD
- Phone Number: 979-458-1484
- Email: le.ruebush@ctral.org
Study Locations
-
-
Texas
-
College Station, Texas, United States, 77843
- Recruiting
- Texas A&M University
-
Contact:
- Marielle P Engelen, PhD
- Phone Number: 979-220-2282
- Email: mpkj.engelen@ctral.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Frail older adults
based on the Fried index
|
Beef, ground, 93% lean meat / 7% fat, patty, cooked, broiled: 100g = 26.2
g protein
Fried tofu: 100g = 18.8 g protein
water (to correct the anabolic data obtained after intake of the proteins for baseline (postabsorptive) values
|
|
Experimental: Pre-Frail Older Adults
based on the Fried index
|
Beef, ground, 93% lean meat / 7% fat, patty, cooked, broiled: 100g = 26.2
g protein
Fried tofu: 100g = 18.8 g protein
water (to correct the anabolic data obtained after intake of the proteins for baseline (postabsorptive) values
|
|
Experimental: Non-Frail Older Adults
based on the Fried index
|
Beef, ground, 93% lean meat / 7% fat, patty, cooked, broiled: 100g = 26.2
g protein
Fried tofu: 100g = 18.8 g protein
water (to correct the anabolic data obtained after intake of the proteins for baseline (postabsorptive) values
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marielle Engelen, Texas A&M University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 107-Beef
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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