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

NCT05798260 | Withdrawn

• 1 other identifier: Pro00101196
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

COVID-19 Acute Respiratory Distress Syndrome

Keywords

mitochondria; ketone monoester; seahorse; ketoneaid; SRC; FCCP; ECAR

Outcome Measures

Primary Outcomes (5)

• Spare Respiratory Capacity (SRC)

  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

  through study completion, an average of 2 months

• Basal Respiration

  Oxygen consumption used to meet cellular ATP demand resulting from mitochondrial proton leak. Shows energetic demand of the cell under baseline conditions.

  through study completion, an average of 2 months

• ATP production-coupled Respiration

  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.

  upon admission

• Maximal Respiration

  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.

  upon admission

• Non-Mitochondrial Respiration

  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.

  through study completion, an average of 2 months

Secondary Outcomes (2)

• Oxygen Consumption Rate (OCR)

  through study completion, an average of 2 months

• extracellular acidification rate (ECAR)

  through study completion, an average of 2 months

Study Arms (2)

Healthy Volunteers

Healthy Volunteers

Diagnostic Test: Agilent Seahorse XF Cell Mito Stress Test

COVID-19 positive admitted to the ICU and on the ventilator

COVID-19 positive admitted to the ICU and on the ventilator

Diagnostic Test: Agilent Seahorse XF Cell Mito Stress Test

Interventions

Agilent Seahorse XF Cell Mito Stress Test DIAGNOSTIC_TEST

The Agilent Seahorse XF Cell Mito Stress Test measures key parameters of mitochondrial function by directly measuring the oxygen consumption rate (OCR) of cells on the Seahorse XFe and XF Extracellular Flux Analyzers. It is a plate-based live cell assay that allows to monitor spare respiratory capacity (SRC), basal respiration, ATP production-coupled respiration, maximal respiration, and non-mitochondrial respiration in real time before and after ketone monoester

Also known as: Ketoneaid (Ketone monoester)

COVID-19 positive admitted to the ICU and on the ventilator; Healthy Volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients admitted at Duke Hospital Medical and Surgical ICU with COVID-19 manifested with ARDS and on the ventilator

You may qualify if:

• COVID-19 with ARDS and on the ventilator

You may not qualify if:

• Pregnant
• \<18 years
• Steroid use

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Christina Barkauskas

Durham, North Carolina, 27710, United States

Location

Study Officials

• Christina Barkauskas, MD

  Research Director Duke Medical ICU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2023
• First Posted: April 4, 2023
• Study Start: June 30, 2024
• Primary Completion: August 31, 2024
• Study Completion: October 31, 2024
• Last Updated: June 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)