Pilot Testing a Novel Non-invasive Lactate Sensor

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-05

Study Completion Date

2023-09-25

Brief Summary

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

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Detailed Description

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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.

Conditions

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Hyperlactatemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Evaluation of non-invasive lactate sensor

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

Group Type EXPERIMENTAL

Lactate sensor (Lactisense)

Intervention Type DEVICE

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

Interventions

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Lactate sensor (Lactisense)

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes