NCT06693544

Brief Summary

Peanuts are considered a functional food and regular consumption is associated with positive health effects. Protein is the second most common nutrient in peanuts after fat. The protein digestibility of peanuts is similar to that of animal protein, and the limiting amino acids in peanuts vary based on the study and are suggested to be lysine, methionine, or threonine. Defining the reduced responsiveness of various dietary proteins to induce anabolism in older adults is critical for preventing and attenuating physical and cognitive health decline.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
2mo left

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress91%
Oct 2024Jul 2026

First Submitted

Initial submission to the registry

October 11, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

October 23, 2024

Completed
26 days until next milestone

First Posted

Study publicly available on registry

November 18, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

November 21, 2025

Status Verified

November 1, 2025

Enrollment Period

1.7 years

First QC Date

October 11, 2024

Last Update Submit

November 19, 2025

Conditions

Keywords

PrandialPlant proteinAnimal protein

Outcome Measures

Primary Outcomes (1)

  • Protein synthesis capacity of plant-based in older adults 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 protein synthesis when taking oral nutrition 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).

    2 weeks

Study Arms (2)

Healthy male older adults

EXPERIMENTAL
Dietary Supplement: Peanut protein

Healthy female older adults

EXPERIMENTAL
Dietary Supplement: Peanut protein

Interventions

Peanut proteinDIETARY_SUPPLEMENT

Commercially available plant-based protein powders

Healthy female older adultsHealthy male older adults

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Previous completion of IRB2023-0549: Prandial Metabolic Phenotyping in Sarcopenic Older Adults Comparing Plant Based and Whey Based Protein (NCT06628349)
  • Age 65-80 years old
  • Stable body-weight (less than ±5% in the previous 6 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
  • 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
  • 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 (i.e., peanut)
  • Experienced issue with intake of peanut or peanut products within the previous year
  • Established daily diet of vegetarian / vegan composition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas A&M University - CTRAL

College Station, Texas, 77843, United States

Location

Study Officials

  • Marielle Engelen, PhD

    Texas A&M University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 11, 2024

First Posted

November 18, 2024

Study Start

October 23, 2024

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

November 21, 2025

Record last verified: 2025-11

Locations