T-Cell Mitochondrial Respiration Response to Ketone Monoester Supplement in Healthy Volunteers and COVID-19

Withdrawn

• Conditions: COVID-19 Acute Respiratory Distress Syndrome
• Interventions: Diagnostic Test: Agilent Seahorse XF Cell Mito Stress Test

• Registration Number: NCT05798260
• Lead Sponsor: Duke University

Brief Summary

T-Cell Mitochondrial Respiration Response to Ketone monoester (Ketoneaid) in Healthy Volunteers and COVID-19

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-28
• Study First Submitted QC: 2023-04-03
• Study First Posted: 2023-04-04
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-30
• Last Update Posted: 2024-06-03
• Study Start: 2024-06-30
• Primary Completion: 2024-08-31
• Study Completion: 2024-10-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

COVID-19 with ARDS and on the ventilator

Exclusion Criteria

• Pregnant
• <18 years
• Steroid use

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COVID-19 positive admitted to the ICU and on the ventilator	Agilent Seahorse XF Cell Mito Stress Test	COVID-19 positive admitted to the ICU and on the ventilator
Healthy Volunteers	Agilent Seahorse XF Cell Mito Stress Test	Healthy Volunteers

Primary Outcome Measures

Name	Time	Method
Spare Respiratory Capacity (SRC)	through study completion, an average of 2 months	This measurement indicates the capability of the cell to respond to an energetic demand as well as how closely the cell is to respiring to its theoretical maximum. The cell's ability to respond to demand can be an indicator of cell fitness or flexibility
ATP production-coupled Respiration	upon admission	The decrease in oxygen consumption rate upon injection of the ATP synthase inhibitor oligomycin represents the portion of basal respiration that was being used to drive ATP production. Shows ATP produced by the mitochondria that contributes to meeting the energetic needs of the cell.
Maximal Respiration	upon admission	The maximal oxygen consumption rate attained by adding the uncoupler FCCP. FCCP mimics a physiological "energy demand" by stimulating the respiratory chain to operate at maximum capacity, which causes rapid oxidation of substrates (sugars, fats, and amino acids) to meet this metabolic challenge. Shows the maximum rate of respiration that the cell can achieve.
Non-Mitochondrial Respiration	through study completion, an average of 2 months	Oxygen consumption that persists due to a subset of cellular enzymes that continue to consume oxygen after the addition of rotenone and antimycin A. This is important to get an accurate measure of mitochondrial respiration.
Basal Respiration	through study completion, an average of 2 months	Oxygen consumption used to meet cellular ATP demand resulting from mitochondrial proton leak. Shows energetic demand of the cell under baseline conditions.

Secondary Outcome Measures

Name	Time	Method
Oxygen Consumption Rate (OCR)	through study completion, an average of 2 months	The oxygen consumption rate (OCR) of cells is an important indicator of normal cellular function. It is used as a parameter to study mitochondrial function as well as a marker of factors triggering the switch from healthy oxidative phosphorylation to aerobic glycolysis
extracellular acidification rate (ECAR)	through study completion, an average of 2 months	Measuring the extracellular acidification rate (ECAR) provides a method for detection of glycolytic flux in T-cells in response to ketone mono ester

Trial Locations

Locations (1)

Christina Barkauskas; 🇺🇸 Durham, North Carolina, United States