Glucose MetabolismMicrodialysisNCT06582381
Evaluation of Biomarkers for Predicting Macronutrient Intake
A study testing Meal set A, Meal set B and Meal set C in people with Glucose Metabolism and Amino Acid Metabolism, run by Texas A&M University at 1 site in United States.
Trial summary
The goal of this clinical trial is to establish the relationship between macronutrient food intake and the resulting blood and intersticial fluid (ISF )levels of small molecule markers, as well as, validate wearable optical readers and data fusion algorithms to accurately predict individual-specific macronutrient… Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Glucose Metabolism, Amino Acid Metabolism
- What is being tested?
- Meal set A, Meal set B and Meal set C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Dec 2023to 28 Apr 2026
- 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability to walk, sit down and stand up independently
- Age 50-75 years old
- Ability to lie in supine or slightly elevated position for approximately 13 hours
- BMI between 25 and 35
- Willingness and ability to comply with the protocol
Who cannot join
- Established diagnosis of malignancy
- Established diagnosis of Insulin or non-Insulin Dependent Diabetes Mellitus
- History of untreated metabolic diseases including hepatic or renal disorder
- Currently on anticoagulants (i.e., warfarin, factor X inhibitors or direct thrombin inhibitors)
- History of deep vein thrombosis, pulmonary embolisms, or known clotting disorders
- Presence of acute illness or metabolically unstable chronic illness
Show all 10Show fewer
- Recent myocardial infarction (less than 1 year)
- Known allergy or intolerance to any of the meal components
- Any other 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
- Failure to give informed consent or Investigator\'s uncertainty about the willingness or ability of the participant to comply with the protocol requirements
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Translational Research in Aging & Longevity
College Station, Texas, 77843
About this study
The goal of this clinical trial is to establish the relationship between macronutrient food intake and the resulting blood and intersticial fluid (ISF )levels of small molecule markers, as well as, validate wearable optical readers and data fusion algorithms to accurately predict individual-specific macronutrient availability in real time.
The study involves 1 screening visit of approximately 2 hours and up to 4 study days of approximately 14 hours. Subjects will be asked to arrive in the fasted state on all study days. Fasting prior to screening is not required. On the screening visit, body weight, height, and body composition by Dual-energy X-ray absorptiometry (DXA) will be measured. In addition, habitual dietary intake, physical activity level (PASE), and quality of life (SGRQ-C) will be assessed.
Read the detailed description
On each study day, body weight and height will be measured. An in-dwelling catheter will be inserted in a peripheral vein of the lower arm or hand to enable blood sampling. The arm will be put in a hot box to allow collecting arterialized venous blood samples. After taking a baseline blood sample, the predefined meal will be consumed within 10 min. Small arterialized venous blood samples (5 ml) will subsequently be drawn multiple times. Samples will be collected in predefined tubes, plasma/serum separated, aliquoted, and stored at -80 deg. Celsius for later assays and/or send to a local accredited laboratory for the concentrations of amino acids and other parameters (including amino acids, fatty acids, glucose, insulin).
In the opposite limb, a commercially available microdialysis catheter will be placed in the forearm following standard operating procedures developed by the European Academy of Allergy \& Clinical Immunology Task Force on Skin Microdialysis. Dialysate will be collected in 30-minute aliquots in microvials for the duration of the study day. Microvials will be weighed before and after sample collection. A syringe filled with perfusate containing mixture of stable tracer-labelled amino acids and glucose will be infused through the syringe pump at a controlled rate.
On each of the study days, subjects will consume two meals with defined composition of macronutrients eight hours apart.
- Conditions
- Glucose Metabolism, Amino Acid Metabolism
- Being tested
- Meal set A, Meal set B, Meal set C, Meal set D
- Keywords
- amino acid, glucose, metabolism, microdialysis, nutrition, stable isotope, macronutrient, biomarker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meal set AOther
morning meal: low carbohydrate, low protein, low fat afternoon meal: high carbohydrate, high protein, high fat
Meal set BOther
morning meal: low carbohydrate, high protien, low fat meal afternoon meal: high carbohydrate, low protein, high fat meal
Meal set COther
morning meal: low carbohydrate, low protien, low fat meal afternoon meal: high carbohydrate, high protein, low fat meal
Meal set DOther
morning meal: high carbohydrate, low protien, low fat meal afternoon meal: low carbohydrate, high protein, high fat meal
| Study group | Role | What they receive |
|---|---|---|
| Healthy male older adults | Experimental | Eight predefined, commercially available meal is administered in a randomized fashion. Two meals are consumed 6 hours apart on each study day. Meals are selected to represent a range of fat, protein, and carbohydrate content. Receives: Other: Meal set A; Other: Meal set B; Other: Meal set C; Other: Meal set D |
| Healthy female older adults | Experimental | Eight predefined, commercially available meal is administered in a randomized fashion. Two meals are consumed 6 hours apart on each study day. Meals are selected to represent a range of fat, protein, and carbohydrate content. Receives: Other: Meal set A; Other: Meal set B; Other: Meal set C; Other: Meal set D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose metabolism
Prediction models of postprandial plasma glucose in relation to the macronutrient content of predefined meals as assessed by plasma and/or ISF concentrations of amino acids, glucose, and/or triglycerides
Measured: Up to 14 hours per study visit, up to 4 visits
Secondary outcomes (1)
Amino acid metabolism
Prediction models of postprandial plasma amino acid patterns in relation to the macronutrient content of predefined meals as assessed by plasma and/or ISF concentrations of amino acids and/or glucose
Measured: Up to 14 hours per study visit, up to 4 visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start6 Dec 2023
- Primary completion28 Apr 2026
- Study completion28 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose 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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 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
- Nicolaas Deutz, MD, PhD, Principal investigator, Texas A&M UniversityMichael McShane, PhD, Principal investigator, Texas A&M University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06582381
- Sponsor's protocol ID
- 91-Micro2
- Other IDs
- R01DK136414
- Acronym
- Microdialysis
- Status last verified
- Aug 2026
- First submitted
- 30 Aug 2024
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data may be shared upon request 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 including: study protocol, statistical analysis plan, and informed consent.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Biomarkers for Predicting Macronutrient Intake
- ClinicalTrials.gov ID
- NCT06582381
- Acronym / sponsor ID
- Microdialysis / 91-Micro2
- Conditions
- Glucose Metabolism, Amino Acid Metabolism
- Keywords
- amino acid, glucose, metabolism, microdialysis, nutrition, stable isotope, macronutrient, biomarker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 6 Dec 2023 (actual)
- Primary completion
- 28 Apr 2026 (actual)
- Study completion
- 28 Apr 2026 (actual)
- First posted
- 3 Sep 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.
The goal of this clinical trial is to establish the relationship between macronutrient food intake and the resulting blood and intersticial fluid (ISF )levels of small molecule markers, as well as, validate wearable optical readers and data fusion algorithms to accurately predict individual-specific macronutrient availability in real time.
The study involves 1 screening visit of approximately 2 hours and up to 4 study days of approximately 14 hours. Subjects will be asked to arrive in the fasted state on all study days. Fasting prior to screening is not required. On the screening visit, body weight, height, and body composition by Dual-energy X-ray absorptiometry (DXA) will be measured. In addition, habitual dietary intake, physical activity level (PASE), and quality of life (SGRQ-C) will be assessed.
Detailed description
On each study day, body weight and height will be measured. An in-dwelling catheter will be inserted in a peripheral vein of the lower arm or hand to enable blood sampling. The arm will be put in a hot box to allow collecting arterialized venous blood samples. After taking a baseline blood sample, the predefined meal will be consumed within 10 min. Small arterialized venous blood samples (5 ml) will subsequently be drawn multiple times. Samples will be collected in predefined tubes, plasma/serum separated, aliquoted, and stored at -80 deg. Celsius for later assays and/or send to a local accredited laboratory for the concentrations of amino acids and other parameters (including amino acids, fatty acids, glucose, insulin).
In the opposite limb, a commercially available microdialysis catheter will be placed in the forearm following standard operating procedures developed by the European Academy of Allergy \& Clinical Immunology Task Force on Skin Microdialysis. Dialysate will be collected in 30-minute aliquots in microvials for the duration of the study day. Microvials will be weighed before and after sample collection. A syringe filled with perfusate containing mixture of stable tracer-labelled amino acids and glucose will be infused through the syringe pump at a controlled rate.
On each of the study days, subjects will consume two meals with defined composition of macronutrients eight hours apart.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy male older adults | Experimental | Other: Meal set A, Other: Meal set B, Other: Meal set C, Other: Meal set DEight predefined, commercially available meal is administered in a randomized fashion. Two meals are consumed 6 hours apart on each study day. Meals are selected to represent a range of fat, protein, and carbohydrate content. |
| Healthy female older adults | Experimental | Other: Meal set A, Other: Meal set B, Other: Meal set C, Other: Meal set DEight predefined, commercially available meal is administered in a randomized fashion. Two meals are consumed 6 hours apart on each study day. Meals are selected to represent a range of fat, protein, and carbohydrate content. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ability to walk, sit down and stand up independently
- Age 50-75 years old
- Ability to lie in supine or slightly elevated position for approximately 13 hours
- BMI between 25 and 35
- Willingness and ability to comply with the protocol
Key exclusion criteria (10 listed)
- Established diagnosis of malignancy
- Established diagnosis of Insulin or non-Insulin Dependent Diabetes Mellitus
- History of untreated metabolic diseases including hepatic or renal disorder
- Currently on anticoagulants (i.e., warfarin, factor X inhibitors or direct thrombin inhibitors)
- History of deep vein thrombosis, pulmonary embolisms, or known clotting disorders
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 |
|---|---|---|
| Meal set Amorning meal: low carbohydrate, low protein, low fat afternoon meal: high carbohydrate, high protein, high fat | Other | Healthy female older adults, Healthy male older adults |
| Meal set Bmorning meal: low carbohydrate, high protien, low fat meal afternoon meal: high carbohydrate, low protein, high fat meal | Other | Healthy female older adults, Healthy male older adults |
| Meal set Cmorning meal: low carbohydrate, low protien, low fat meal afternoon meal: high carbohydrate, high protein, low fat meal | Other | Healthy female older adults, Healthy male older adults |
| Meal set Dmorning meal: high carbohydrate, low protien, low fat meal afternoon meal: low carbohydrate, high protein, high fat meal | Other | Healthy female older adults, Healthy male older adults |
Primary outcome
Glucose metabolism
Time frame: Up to 14 hours per study visit, up to 4 visits
Prediction models of postprandial plasma glucose in relation to the macronutrient content of predefined meals as assessed by plasma and/or ISF concentrations of amino acids, glucose, and/or triglycerides
1 secondary outcome
Amino acid metabolism
Time frame: Up to 14 hours per study visit, up to 4 visits
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 28 Aug 2026.
- Individual participant dataSharing planned: Yes. Data may be shared upon request 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 including: study protocol, statistical analysis plan, and informed consent.
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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.
Nicolaas Deutz, MD, PhD principal investigator
Texas A&M University
Michael McShane, 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 Meal set A, Meal set B and Meal set C in people with Glucose Metabolism and Amino Acid 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 5 inclusion and 10 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 28 Aug 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?
Glucose metabolism (time frame: Up to 14 hours per study visit, up to 4 visits). 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 28 Aug 2026.