Evaluation of Biomarkers for Predicting Macronutrient Intake

Texas A&M University

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.

Description

On each study day, body weight and height will be measured. An in-dwelling catheter will be inserted in a peripheral vein of the lower arm or hand to enable blood sampling. The arm will be put in a hot box to allow collecting arterialized venous blood samples. After taking a baseline blood sample, the predefined meal will be consumed within 10 min. Small arterialized venous blood samples (5 ml) will subsequently be drawn multiple times. Samples will be collected in predefined tubes, plasma/serum separated, aliquoted, and stored at -80 deg. Celsius for later assays and/or send to a local accred…

Eligibility

Age range: 50–75 years
Sex: All
Healthy volunteers: Yes

Detailed 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 throm…

Interventions

Other
Meal set A
morning meal: low carbohydrate, low protein, low fat afternoon meal: high carbohydrate, high protein, high fat
Other
Meal set B
morning meal: low carbohydrate, high protien, low fat meal afternoon meal: high carbohydrate, low protein, high fat meal
Other
Meal set C
morning meal: low carbohydrate, low protien, low fat meal afternoon meal: high carbohydrate, high protein, low fat meal
Other
Meal set D
morning meal: high carbohydrate, low protien, low fat meal afternoon meal: low carbohydrate, high protein, high fat meal

Location

Center for Translational Research in Aging & Longevity
College Station, Texas