Evaluation of Biomarkers for Predicting Macronutrient Intake

Recruiting now · Not applicable

Conditions studied: Glucose Metabolism, Amino Acid Metabolism

In brief

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.

Key facts

Study ID

NCT06582381

Run by

Texas A&M University

People needed

33

Starts

2023-12-06

Expected to finish

2026-12-01

Last updated by the study team

2025-07-20

Who can join

Age: 50 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• Center for Translational Research in Aging & Longevity — College Station, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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