Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06582381
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-30
Brief Title:
Evaluation of Biomarkers for Predicting Macronutrient Intake
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of Biomarkers for Predicting Macronutrient Intake
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Microdialysis
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
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 plasmaserum separated aliquoted and stored at -80 deg Celsius for later assays andor 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 amp 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
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 amp 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None