NCT06582381 Evaluation of Biomarkers for Predicting Macronutrient Intake
| NCT ID | NCT06582381 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Texas A&M University |
| Condition | Glucose Metabolism |
| Study Type | INTERVENTIONAL |
| Enrollment | 33 participants |
| Start Date | 2023-12-06 |
| Primary Completion | 2026-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 33 participants in total. It began in 2023-12-06 with a primary completion date of 2026-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility Criteria
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
Contact & Investigator
Nicolaas Deutz, MD, PhD
PRINCIPAL INVESTIGATOR
Texas A&M University
Frequently Asked Questions
Who can join the NCT06582381 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 75 Years, studying Glucose Metabolism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06582381 currently recruiting?
Yes, NCT06582381 is actively recruiting participants. Contact the research team at lruebush@tamu.edu for enrollment information.
Where is the NCT06582381 trial being conducted?
This trial is being conducted at College Station, United States.
Who is sponsoring the NCT06582381 clinical trial?
NCT06582381 is sponsored by Texas A&M University. The principal investigator is Nicolaas Deutz, MD, PhD at Texas A&M University. The trial plans to enroll 33 participants.