Prandial Metabolic Phenotyping in Sarcopenic Older Adults Comparing Plant Based and Whey Based Protein

NCT06628349 | Recruiting

• 1 other identifier: 94- Plant Protein Sips
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Protein Metabolism

Keywords

Prandial; Sarcopenia; Plant protein; Animal protein

Outcome Measures

Primary Outcomes (1)

• 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.

  4 weeks

Study Arms (8)

Healthy male older adults

EXPERIMENTAL

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)

Healthy female older adults

EXPERIMENTAL

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)

Healthy male old older adults

EXPERIMENTAL

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)

Healthy female old older adults

EXPERIMENTAL

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)

Sarcopenic male old older adults

EXPERIMENTAL

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)

Sarcopenic female old older adults

EXPERIMENTAL

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)

COPD male older adults

EXPERIMENTAL

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)

COPD female older adults

EXPERIMENTAL

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)

Interventions

Whey Protein Isolate 90% DIETARY_SUPPLEMENT

Commercially available animal based protein powders

COPD female older adults; COPD male older adults; Healthy female old older adults; Healthy female older adults; Healthy male old older adults; Healthy male older adults; Sarcopenic female old older adults; Sarcopenic male old older adults

Soy Protein Isolate (90% Protein) DIETARY_SUPPLEMENT

Commercially available plant based protein powders

COPD female older adults; COPD male older adults; Healthy female old older adults; Healthy female older adults; Healthy male old older adults; Healthy male older adults; Sarcopenic female old older adults; Sarcopenic male old older adults

Organic Pea Protein Isolate DIETARY_SUPPLEMENT

Commercially available plant based protein powders

COPD female older adults; COPD male older adults; Healthy female old older adults; Healthy female older adults; Healthy male old older adults; Healthy male older adults; Sarcopenic female old older adults; Sarcopenic male old older adults

Placebo (Water) DIETARY_SUPPLEMENT

Normal drinking water

COPD female older adults; COPD male older adults; Healthy female old older adults; Healthy female older adults; Healthy male old older adults; Healthy male older adults; Sarcopenic female old older adults; Sarcopenic male old older adults

Eligibility Criteria

• Age: 50 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 50-95 years old
• Diagnosis of Chronic Obstructive Pulmonary Disease (COPD); COPD group only
• Stable body-weight (±5%) for the past 3 months
• Ability to walk, sit down, and stand up (independently or with walking assistance device)
• Willingness to lay supine in bed for up to 6 hours
• Willingness and ability to comply with the protocol

You may not qualify if:

• 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 acute illness or metabolically unstable chronic illness
• Hysterectomy
• Active dependence of alcohol or drugs
• Use of short course of oral corticosteroids within 4 weeks preceding study day
• Current use of long-term oral corticosteroids
• Use of protein or amino acids containing nutritional supplements within 5 days of the first study day
• Presence of fever within the last 3 days
• Planned elective surgery requiring 2 or more days of hospitalization during the entire study
• (Possible) pregnancy
• 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, pea, or whey - dairy)

Sponsors & Collaborators

• Texas A&M University: lead

Study Sites (1)

Texas A&M University - CTRAL

College Station, Texas, 77845, United States

RECRUITING

MeSH Terms

Conditions

Sarcopenia

Interventions

Soybean Proteins; Proteins; Water

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant Proteins; Amino Acids, Peptides, and Proteins; Plant Proteins, Dietary; Dietary Proteins; Food; Diet, Food, and Nutrition; Physiological Phenomena; Soy Foods; Vegetable Products; Vegetables; Food and Beverages; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Marielle Engelen, PhD

  Texas A&M University

  PRINCIPAL INVESTIGATOR

• Nicolaas Deutz, MD, PhD

  Texas A&M University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marielle Engelen, PhD

CONTACT

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

Savanah Knezek, BS

CONTACT

979-442-8468; research@ctral.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: October 4, 2024
• Study Start: February 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 25, 2025

Record last verified: 2025-11

Locations

US (1)