Protein MetabolismNCT06693544
Peanut Sip Feeding Protocol
A study testing Peanut protein in people with Protein Metabolism, run by Texas A&M University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Protein Metabolism
- What is being tested?
- Peanut protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2024to 14 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas A&M University - CTRAL
College Station, Texas, 77843
About this study
Official title: Comparing Intracellular Anabolic Capacity and Food-derived Amino Acid Bioavailability of Peanut and Dairy Protein in Healthy Non-frail Older Adults at Risk for (Pre)Frailty
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.
Read the detailed description
The study will be conducted in healthy, non-frail 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.Our research objective is to examine whether differences exist in the anabolic response and bioavailability of amino acids coming from peanut-based protein as compared to animal-based protein in older adults at risk for (pre-)frailty, known to contribute to poor muscle and brain health. 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 45g of peanut protein (plant based). Comparison of results from meals taken while enrolled in NCTNCT06628349 will be performed. Participants will have the option of adding sugar free (SF) vanilla syrup, SF caramel syrup, or SF chocolate syrup to their meals.
- Conditions
- Protein Metabolism
- Being tested
- Peanut protein
- Keywords
- Prandial, Plant protein, Animal protein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peanut proteinDietary supplement
Commercially available plant-based protein powders
| Study group | Role | What they receive |
|---|---|---|
| Healthy male older adults | Experimental | Not described Receives: Dietary Supplement: Peanut protein |
| Healthy female older adults | Experimental | Not described Receives: Dietary Supplement: Peanut protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start23 Oct 2024
- Primary completion14 Feb 2025
- Study completion14 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Protein MetabolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas A&M University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marielle PKJ Engelen, PhD, Texas A&M University
- Investigators
- Marielle Engelen, PhD, Principal investigator, Texas A&M University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06693544
- Sponsor's protocol ID
- 98-Peanut
- Status last verified
- Sep 2026
- First submitted
- 11 Oct 2024
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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).
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Intracellular Anabolic Capacity and Food-derived Amino Acid Bioavailability of Peanut and Dairy Protein in Healthy Non-frail Older Adults at Risk for (Pre)Frailty
- ClinicalTrials.gov ID
- NCT06693544
- Acronym / sponsor ID
- 98-Peanut
- Conditions
- Protein Metabolism
- Keywords
- Prandial, Plant protein, Animal protein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Study start
- 23 Oct 2024 (actual)
- Primary completion
- 14 Feb 2025 (actual)
- Study completion
- 14 Feb 2025 (actual)
- First posted
- 18 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study will be conducted in healthy, non-frail 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.Our research objective is to examine whether differences exist in the anabolic response and bioavailability of amino acids coming from peanut-based protein as compared to animal-based protein in older adults at risk for (pre-)frailty, known to contribute to poor muscle and brain health. 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 45g of peanut protein (plant based). Comparison of results from meals taken while enrolled in NCTNCT06628349 will be performed. Participants will have the option of adding sugar free (SF) vanilla syrup, SF caramel syrup, or SF chocolate syrup to their meals.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy male older adults | Experimental | Dietary Supplement: Peanut protein |
| Healthy female older adults | Experimental | Dietary Supplement: Peanut protein |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peanut proteinCommercially available plant-based protein powders | Dietary supplement | Healthy female older adults, Healthy male older adults |
Primary outcome
Protein synthesis capacity of plant-based in older adults without sarcopenia measured by the use of stable isotope tracers
Time frame: 2 weeks
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marielle Engelen, PhD principal investigator
Texas A&M University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peanut protein in people with Protein Metabolism, run by Texas A&M University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Protein synthesis capacity of plant-based in older adults without sarcopenia measured by the use of stable isotope tracers (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.