Evaluation of Biomarkers for Predicting Macronutrient Intake

Not Applicable

Recruiting

• Conditions: Glucose Metabolism; Amino Acid Metabolism
• Interventions: Other: Meal set A; Other: Meal set B; Other: Meal set C; Other: Meal set D

• Registration Number: NCT06582381
• Lead Sponsor: Texas A&M University

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.

Detailed 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 accredited laboratory for the concentrations of amino acids and other parameters (including amino acids, fatty acids, glucose, insulin).

In the opposite limb, a commercially available microdialysis catheter will be placed in the forearm following standard operating procedures developed by the European Academy of Allergy \& Clinical Immunology Task Force on Skin Microdialysis. Dialysate will be collected in 30-minute aliquots in microvials for the duration of the study day. Microvials will be weighed before and after sample collection. A syringe filled with perfusate containing mixture of stable tracer-labelled amino acids and glucose will be infused through the syringe pump at a controlled rate.

On each of the study days, subjects will consume two meals with defined composition of macronutrients eight hours apart.

Study Timeline

• Study Start: 2023-12-06
• Status Verified: 2024-08
• Study First Submitted: 2024-08-30
• Study First Submitted QC: 2024-08-30
• Last Update Submitted: 2024-08-30
• Study First Posted: 2024-09-03
• Last Update Posted: 2024-09-03
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Healthy male older adults	Meal set A	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.
Healthy male older adults	Meal set B	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.
Healthy male older adults	Meal set C	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.
Healthy male older adults	Meal set D	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.
Healthy female older adults	Meal set A	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.
Healthy female older adults	Meal set B	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.
Healthy female older adults	Meal set C	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.
Healthy female older adults	Meal set D	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 Measures

Name	Time	Method
Glucose metabolism	Up to 14 hours per study visit, up to 4 visits	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

Secondary Outcome Measures

Name	Time	Method
Amino acid metabolism	Up to 14 hours per study visit, up to 4 visits	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

Trial Locations

Locations (1)

Center for Translational Research in Aging & Longevity; 🇺🇸 College Station, Texas, United States