Evaluation of Biomarkers for Predicting Macronutrient Intake

Part of paid clinical trials in College Station, Texas.

Sponsor
Texas A&M University
Study ID
NCT06582381
Status
Recruiting
Apply to this trial

Conditions

  • Amino Acid Metabolism
  • Glucose Metabolism

Eligibility Criteria

Sex
ALL
Age
50 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Dec 6, 2023
Status verified
Jul 2025
Primary completion
Jan 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
33 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: Healthy male older adults
    Eight predefined, commercially available meal is administered in a randomized fashion. Two meals are consumed 6 hours apart on each study day. Meals are selected to represent a range of fat, protein, and carbohydrate content.
  • Experimental: Healthy female older adults
    Eight predefined, commercially available meal is administered in a randomized fashion. Two meals are consumed 6 hours apart on each study day. Meals are selected to represent a range of fat, protein, and carbohydrate content.

Primary Outcome Measure

Glucose metabolism [ Time Frame: Up to 14 hours per study visit, up to 4 visits ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Center for Translational Research in Aging & LongevityCollege StationTexas77843-

Find similar trials in College Station, TX

By research site
Center for Translational Research in Aging & Longevity· College Station, TX

Related Studies