Evaluation of Biomarkers for Predicting Macronutrient Intake

ConditionsGlucose Metabolism Amino Acid Metabolism

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

This trial accepts healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

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

Treatment groups

33 Participants

are divided into 2 treatment groups

Group A: Healthy male older adultsExperimental treatment 4 interventions

Group B: Healthy female older adultsExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

Glucose metabolism

Prediction models of postprandial plasma glucose in relation to the macronutrient content of predefined meals as assessed by plasma and/or ISF concentrations of amino acids, glucose, and/or triglycerides

Time frame

Up to 14 hours per study visit, up to 4 visits

Secondary outcomes

Amino acid metabolism

Prediction models of postprandial plasma amino acid patterns in relation to the macronutrient content of predefined meals as assessed by plasma and/or ISF concentrations of amino acids and/or glucose

Time frame

Up to 14 hours per study visit, up to 4 visits

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Texas A&M University

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Source ClinicalTrials.gov

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