NCT06582381 · Texas A&M University
Evaluation of Biomarkers for Predicting Macronutrient Intake
(Microdialysis)
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
Meal set A
morning meal: low carbohydrate, low protein, low fat afternoon meal: high carbohydrate, high protein, high fat
OTHER
Meal set B
morning meal: low carbohydrate, high protien, low fat meal afternoon meal: high carbohydrate, low protein, high fat meal
OTHER
Meal set C
morning meal: low carbohydrate, low protien, low fat meal afternoon meal: high carbohydrate, high protein, low fat meal
OTHER
Meal set D
morning meal: high carbohydrate, low protien, low fat meal afternoon meal: low carbohydrate, high protein, high fat meal
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
- 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
Where
- College Station, Texas
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 20, 2025 · Source of record for eligibility and locations