RecruitingNot ApplicableNCT06582381

Evaluation of Biomarkers for Predicting Macronutrient Intake


Sponsor

Texas A&M University

Enrollment

33 participants

Start Date

Dec 6, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 50 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is developing and validating wearable sensors and AI algorithms that can accurately measure levels of macronutrients — proteins, fats, and carbohydrates — in the blood and tissue fluid in real time after a meal, potentially allowing personalized nutrition monitoring without repeated blood draws. Adults aged 50 to 75 with a BMI between 25 and 35 who can walk independently and lie comfortably for extended periods may be eligible, unless they have cancer, diabetes, blood clotting disorders, or other serious health conditions. Participation involves up to 4 study days of about 14 hours each, during which you consume predefined meals, have a small IV catheter and a tissue fluid sampling device placed in your arm, and provide blood samples at set intervals. This summary was prepared to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERMeal set A

morning meal: low carbohydrate, low protein, low fat afternoon meal: high carbohydrate, high protein, high fat

OTHERMeal set B

morning meal: low carbohydrate, high protien, low fat meal afternoon meal: high carbohydrate, low protein, high fat meal

OTHERMeal set C

morning meal: low carbohydrate, low protien, low fat meal afternoon meal: high carbohydrate, high protein, low fat meal

OTHERMeal set D

morning meal: high carbohydrate, low protien, low fat meal afternoon meal: low carbohydrate, high protein, high fat meal


Locations(1)

Center for Translational Research in Aging & Longevity

College Station, Texas, United States

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NCT06582381


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