Pilot Testing a Novel Non-invasive Lactate Sensor

NCT05649358 | Completed

• 1 other identifier: Pro00115293
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

To test the efficacy and accuracy of a novel non-invasive lactate sensor in humans undergoing strenuous leg exercise.

Conditions

Hyperlactatemia

Outcome Measures

Primary Outcomes (1)

• That the lactate sensor under test is able track increase in interstitial lactate levels in exercising humans that follow the same time course as lactate values obtained from a commercial blood capillary lactate monitor.

  The novel sensor data will be compared to lactate values measured simultaneously with a commercial blood capillary lactate monitor in exercising humans.

  6 months

Study Arms (1)

Evaluation of non-invasive lactate sensor

EXPERIMENTAL

To determine the efficacy and accuracy of the non-invasive lactate sensor

Device: Lactate sensor (Lactisense)

Interventions

Lactate sensor (Lactisense) DEVICE

Non-invasive monitoring of interstitial lactate levels during and after exercise.

Evaluation of non-invasive lactate sensor

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy and physically active volunteers

You may not qualify if:

• Existing health conditions e.g blood pressure \> 150/95, joint injury that would contraindicate exercise. Individuals who answer "yes" to any of the health condition questions on the PAR-Q questionnaire will also be excluded. As ketones might interfere with the sensor signal, we will exclude anyone with metabolic conditions or following a ketogenic diet.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

Alberta Diabetes Institute, University of Alberta

Edmonton, Alberta, T6G2E1, Canada

Location

MeSH Terms

Conditions

Hyperlactatemia

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Peter E Light, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The investigators will test the device on 8 male and 8 female participants to determine if there are any sex differences in the performance of the sensor. As there is likely going to be inter-individual variability in the participants, the investigators have chosen to test 8 males and 8 females rather than 5 and 5 as suggested by the reviewer.

Study Record Dates

• First Submitted: August 18, 2022
• First Posted: December 14, 2022
• Study Start: December 5, 2022
• Primary Completion: August 31, 2023
• Study Completion: September 25, 2023
• Last Updated: October 5, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)