Evaluation of Biomarkers for Predicting Macronutrient Intake

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.

Conditions

• Glucose Metabolism
• Amino Acid Metabolism

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

Sponsors & Collaborators

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

  collaborator NIH

• Texas A&M University

  lead OTHER

Principal Investigators

• Nicolaas Deutz, MD, PhD · Texas A&M University

• Michael McShane, PhD · Texas A&M University

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

50 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-12-06

Primary Completion

2026-01-31

Completion

2026-12-31

Countries

• United States

Study Locations