Evaluation of Biomarkers for Predicting Macronutrient Intake
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-75
SponsorTexas A&M University
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Meal set A
- Meal set B
- Meal set C
- Meal set D
Treatment groups
33 Participants
are divided into 2 treatment groupsSponsors and collaborators
Texas A&M University
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov