Actively Recruiting
Evaluation of Biomarkers for Predicting Macronutrient Intake in Healthy Older Adults
Led by Texas A&M University · Updated on 2025-07-20
33
Participants Needed
1
Research Sites
47 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
Researchers are studying how different macronutrient intakes affect levels of small molecule markers in blood and interstitial fluid. The study aims to validate wearable optical readers and data fusion algorithms that can predict individual-specific macronutrient availability in real time. This trial focuses on healthy adults aged 50 to 75 years, investigating glucose and amino acid metabolism. Participants will attend one screening visit lasting about 2 hours and up to four study days of approximately 14 hours each. On study days, they consume two predefined meals with specific macronutrient compositions six to eight hours apart. Blood samples are taken via an in-dwelling catheter with the arm heated to collect arterialized venous blood. Microdialysis catheters collect samples from the opposite arm to analyze metabolism markers. During the study, body weight, height, and body composition are measured. Participants complete questionnaires on dietary habits, physical activity, and quality of life. Blood and dialysate samples are processed and stored for later analysis of amino acids, fatty acids, glucose, and insulin. The primary outcome is glucose metabolism measured over up to 14 hours per visit, with secondary outcomes including amino acid metabolism. Participants’ safety and adherence are monitored throughout the study which ends in December 2026.
CONDITIONS
Brief 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
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 14 hours per study visit, up to 4 visits
Participants consume two predefined meals with varied macronutrient composition on each study day. Blood samples and microdialysis samples are collected multiple times during the approximately 14-hour study visit to evaluate metabolism.
Up to 4 full-day visits lasting about 14 hours each
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
R
Raven McNew, PhD
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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