An interventional study of Whey Protein Isolate 90% and Soy Protein Isolate (90% Protein) in Protein Metabolism, sponsored by Texas A&M University. Recruiting at 1 site in United States. Open to participants aged 50 Years to 95 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-25.
Sponsored by Texas A&M University · Not applicable, Interventional, and Other
The researchers overall objective is to determine whether plant and animal protein based proteins affect the anabolic responses across aging populations differently due to specific changes in the essential amino acids (EAA) and non-essential amino acids (NEAA) kinetic responses. The researchers central hypothesis is that a high EAA to NEAA ratio in a protein meal is related to higher anabolic response to the meal. The researchers also hypothesize that the type of NEAA in a protein meal also affects the anabolic capacity of the meal. The researchers rationale is that finding the amino acid composition of a meal that will maximally induce protein anabolism will guide novel nutritional approaches to prevent and treat sarcopenia, thereby reducing both overall economic burden and improving individual patient outcomes.
The study will be conducted in sarcopenic and non-sarcopenic older adults, stratified into different age categories. A sip feeding model will be used as it is a good model to establish the anabolic capacity of meals. The researchers hypothesize that plant-based protein induces less protein anabolism, due to lower production of EAA and higher production of non-essential amino acids (NEAA) as compared to dairy protein. The NEAA kinetics will be different between the plant proteins as soy protein has relatively high levels of the NEAA arginine and Pea protein of aspartate/glutamate. The researchers results will guide future nutritional advice on replacing daily protein with plant-based proteins while keeping the overall effects on metabolism comparable for both the EAA and NEAA. 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 the liquid nutritional supplement as sip feeds every 20 minutes for 5 hours. The liquid nutrition supplements will contain the following proteins: (1) 45g of whey protein (dairy based), (2) 45g of soy protein (plant based), (3) 45g of pea protein (plant based), or (4) Placebo (water). Participants will have the option of adding sugar free (SF) vanilla syrup, SF caramel syrup, or SF chocolate syrup to their meals.
1,208 studies on the registry are indexed under Sarcopenia; 402 are open to participants now.
This study's planned enrollment of 100 is above the median of 60 across 775 interventional studies indexed under Sarcopenia.
Browse Sarcopenia studies →Texas A&M University is the lead sponsor of 123 studies on the registry; 23 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 2 (29%) have results posted.
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Exclusion Criteria:
Dietary Supplement: Whey Protein Isolate 90%. Commercially available Dietary Supplement: Soy Protein Isolate (90% Protein). Commercially available Dietary Supplement: Organic Pea Protein Isolate. Commercially available Dietary Supplement: Placebo - Water
Dietary Supplement: Whey Protein Isolate 90% · Dietary Supplement: Soy Protein Isolate (90% Protein) · Dietary Supplement: Organic Pea Protein Isolate · Dietary Supplement: Placebo (Water)
Dietary Supplement: Whey Protein Isolate 90%. Commercially available Dietary Supplement: Soy Protein Isolate (90% Protein). Commercially available Dietary Supplement: Organic Pea Protein Isolate. Commercially available Dietary Supplement: Placebo - Water
Dietary Supplement: Whey Protein Isolate 90% · Dietary Supplement: Soy Protein Isolate (90% Protein) · Dietary Supplement: Organic Pea Protein Isolate · Dietary Supplement: Placebo (Water)
Dietary Supplement: Whey Protein Isolate 90%. Commercially available Dietary Supplement: Soy Protein Isolate (90% Protein). Commercially available Dietary Supplement: Organic Pea Protein Isolate. Commercially available Dietary Supplement: Placebo - Water
Dietary Supplement: Whey Protein Isolate 90% · Dietary Supplement: Soy Protein Isolate (90% Protein) · Dietary Supplement: Organic Pea Protein Isolate · Dietary Supplement: Placebo (Water)
Dietary Supplement: Whey Protein Isolate 90%. Commercially available Dietary Supplement: Soy Protein Isolate (90% Protein). Commercially available Dietary Supplement: Organic Pea Protein Isolate. Commercially available Dietary Supplement: Placebo - Water
Dietary Supplement: Whey Protein Isolate 90% · Dietary Supplement: Soy Protein Isolate (90% Protein) · Dietary Supplement: Organic Pea Protein Isolate · Dietary Supplement: Placebo (Water)
Dietary Supplement: Whey Protein Isolate 90%. Commercially available Dietary Supplement: Soy Protein Isolate (90% Protein). Commercially available Dietary Supplement: Organic Pea Protein Isolate. Commercially available Dietary Supplement: Placebo - Water
Dietary Supplement: Whey Protein Isolate 90% · Dietary Supplement: Soy Protein Isolate (90% Protein) · Dietary Supplement: Organic Pea Protein Isolate · Dietary Supplement: Placebo (Water)
Dietary Supplement: Whey Protein Isolate 90%. Commercially available Dietary Supplement: Soy Protein Isolate (90% Protein). Commercially available Dietary Supplement: Organic Pea Protein Isolate. Commercially available Dietary Supplement: Placebo - Water
Dietary Supplement: Whey Protein Isolate 90% · Dietary Supplement: Soy Protein Isolate (90% Protein) · Dietary Supplement: Organic Pea Protein Isolate · Dietary Supplement: Placebo (Water)
Dietary Supplement: Whey Protein Isolate 90%. Commercially available Dietary Supplement: Soy Protein Isolate (90% Protein). Commercially available Dietary Supplement: Organic Pea Protein Isolate. Commercially available Dietary Supplement: Placebo - Water
Dietary Supplement: Whey Protein Isolate 90% · Dietary Supplement: Soy Protein Isolate (90% Protein) · Dietary Supplement: Organic Pea Protein Isolate · Dietary Supplement: Placebo (Water)
Dietary Supplement: Whey Protein Isolate 90%. Commercially available Dietary Supplement: Soy Protein Isolate (90% Protein). Commercially available Dietary Supplement: Organic Pea Protein Isolate. Commercially available Dietary Supplement: Placebo - Water
Dietary Supplement: Whey Protein Isolate 90% · Dietary Supplement: Soy Protein Isolate (90% Protein) · Dietary Supplement: Organic Pea Protein Isolate · Dietary Supplement: Placebo (Water)
Commercially available animal based protein powders
Commercially available plant based protein powders
Commercially available plant based protein powders
Normal drinking water
Protein and amino acid synthesis capacity of plant-based and animal-based protein in older adults with or without sarcopenia 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, and use the results for preparation of papers for presentation, publication, and final reports. The researchers main hypothesis is that plant-based protein induces less protein anabolism, due to lower whole body production of essential amino acids (EAA) and higher production of non-essential amino acids (NEAA) as compared to dairy protein.
Time frame: 4 weeks
Plan to share: Undecided — Data may be shared upon request for up to 6 years beyond completion of the trial based on methods/proposals approved by both parties' institutional review committees. Individual participant data that underlie the results of the trial may be shared after de-identification (text, tables, figures, and appendices). Additional documents available per request include: study protocol, statistical analysis plan, and informed consent. Requests should be directed to Dr. Marielle Engelen (mpkj.engelen@ctral.org).
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