Pilot Testing a Novel Non-invasive Lactate Sensor

Pilot Testing a Novel Non-invasive Lactate Sensor Using Split Ring Low Energy Microwave Sensors

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

Study Overview

• Status: Completed
• Conditions: Hyperlactatemia
• Intervention / Treatment: Device: Lactate sensor (Lactisense)

Detailed Description

The study investigators have designed a novel non-invasive lactate sensor (Lactisense) Lactisense is a planar, flexible, passive, chip-less resonator that can be taped to the skin in order to measure lactate levels in the body. It sends a signal to a nearby reader, which can be translated into a concentration value. It has so far been tested in the lab with good accuracy, but has not been tested on humans. The sensors are designed to use very low energy microwaves that can detect alterations in interstitial and muscle metabolites.

In this study the investigators will test the sensor by having participants perform strenuous exercise (lifting weights) with Lactisense sensors attached to their skin on the top of the thigh and upper arm to evaluate lactate levels at the site of production and systemic levels respectively. The exercise will be performed using a well-established protocol to elevate lactate levels using a leg-press weights machine. The investigators will use a commercial capillary blood lactate meter (via finger prick) to verify whether lactate levels are actually changing in the body, and use Lactisense to try to measure these changes and compare to the values obtained using the commercial capillary blood lactate meter.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G2E1
      • Alberta Diabetes Institute, University of Alberta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Healthy and physically active volunteers

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Evaluation of non-invasive lactate sensor; To determine the efficacy and accuracy of the non-invasive lactate sensor	Device: Lactate sensor (Lactisense); Non-invasive monitoring of interstitial lactate levels during and after exercise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Alberta
• Investigators: Principal Investigator: Peter E Light, PhD, University of Alberta

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2022
• Primary Completion (Actual): August 31, 2023
• Study Completion (Actual): September 25, 2023

Study Registration Dates

• First Submitted: August 18, 2022
• First Submitted That Met QC Criteria: December 13, 2022
• First Posted (Actual): December 14, 2022

Study Record Updates

• Last Update Posted (Actual): October 5, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Hyperlactatemia
• Other Study ID Numbers: Pro00115293

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No