Evaluation of Biomarkers for Predicting Macronutrient Intake

NCT06582381 | Recruiting

• 2 other identifiers: 91-Micro2R01DK136414
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

amino acid; glucose; metabolism; microdialysis; nutrition; stable isotope; macronutrient; biomarker

Outcome Measures

Primary Outcomes (1)

• 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

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

Secondary Outcomes (1)

• Amino acid metabolism

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

Study Arms (2)

Healthy male older adults

EXPERIMENTAL

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.

Other: Meal set A; Other: Meal set B; Other: Meal set C; Other: Meal set D

Healthy female older adults

EXPERIMENTAL

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.

Other: Meal set A; Other: Meal set B; Other: Meal set C; Other: Meal set D

Interventions

Meal set A OTHER

morning meal: low carbohydrate, low protein, low fat afternoon meal: high carbohydrate, high protein, high fat

Healthy female older adults; Healthy male older adults

Meal set B OTHER

morning meal: low carbohydrate, high protien, low fat meal afternoon meal: high carbohydrate, low protein, high fat meal

Healthy female older adults; Healthy male older adults

Meal set C OTHER

morning meal: low carbohydrate, low protien, low fat meal afternoon meal: high carbohydrate, high protein, low fat meal

Healthy female older adults; Healthy male older adults

Meal set D OTHER

morning meal: high carbohydrate, low protien, low fat meal afternoon meal: low carbohydrate, high protein, high fat meal

Healthy female older adults; Healthy male older adults

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 thrombosis, pulmonary embolisms, or known clotting disorders
• Presence of acute illness or metabolically unstable chronic illness
• Recent myocardial infarction (less than 1 year)
• Known allergy or intolerance to any of the meal components
• Any other condition according to the PI or nurse that was found during the screening visit, that would interfere with the study or safety of the patient
• Failure to give informed consent or Investigator\'s uncertainty about the willingness or ability of the participant to comply with the protocol requirements

Sponsors & Collaborators

• Texas A&M University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Center for Translational Research in Aging & Longevity

College Station, Texas, 77843, United States

RECRUITING

Study Officials

• Nicolaas Deutz, MD, PhD

  Texas A&M University

  PRINCIPAL INVESTIGATOR

• Michael McShane, PhD

  Texas A&M University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Ruebush, PhD

CONTACT

9792185515; lruebush@tamu.edu

Raven McNew, PhD

CONTACT

9794221789; raven.mcnew@tamu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Laboratory staff and data scientists will not know the meals received when analyzing samples and initial statistical modeling
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 30, 2024
• First Posted: September 3, 2024
• Study Start: December 6, 2023
• Primary Completion: January 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: up to 6 years beyond the completion of the trial
• Access Criteria: Contact PI - Dr. Michael McShane (mcshane@tamu.edu)

Locations

US (1)