Actively Recruiting
Evaluation of Biomarkers for Predicting Macronutrient Intake
Led by Texas A&M University · Updated on 2025-07-20
33
Participants Needed
1
Research Sites
155 weeks
Total Duration
On this page
Sponsors
T
Texas A&M University
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial 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. 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.
CONDITIONS
Official Title
Evaluation of Biomarkers for Predicting Macronutrient Intake
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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
AI-Screening
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Trial Site Locations
Total: 1 location
1
Center for Translational Research in Aging & Longevity
College Station, Texas, United States, 77843
Actively Recruiting
Research Team
L
Laura Ruebush, PhD
CONTACT
R
Raven McNew, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
2
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