Evaluating how food intake affects blood markers
Evaluation of Biomarkers for Predicting Macronutrient Intake
This study is testing how different types of food affect blood markers in people while also checking if new wearable devices can help track nutrient levels in real-time.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 33 (estimated) |
| Ages | 50 Years to 75 Years |
| Sex | All |
| Sponsor | Texas A&M University Academic / other |
| Locations | 1 site (College Station, Texas) |
| Trial ID | NCT06582381 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to establish the relationship between macronutrient food intake and the resulting levels of small molecule markers in blood and interstitial fluid. Participants will undergo a screening visit followed by up to four study days where they will consume predefined meals while undergoing blood sampling and microdialysis to collect data on glucose and amino acid metabolism. The study also seeks to validate wearable optical readers and data fusion algorithms for real-time prediction of macronutrient availability. Participants will be monitored for body composition and quality of life throughout the study.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 50-75 years with a BMI between 25 and 35 who can comply with the study protocol.
Not a fit: Patients with established diabetes, malignancies, or untreated metabolic diseases are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide personalized nutrition insights that improve metabolic health and dietary recommendations for individuals.
How similar studies have performed: While there have been studies on glucose and amino acid metabolism, the specific approach of using wearable technology and real-time data fusion for macronutrient prediction is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
College Station, Texas
- Center for Translational Research in Aging & Longevity — College Station, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Nicolaas Deutz, MD, PhD — Texas A&M University
- Study coordinator: Laura Ruebush, PhD
- Email: lruebush@tamu.edu
- Phone: 9792185515
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.