protocolSection identificationModule nctId: NCT06330363, orgStudyIdInfo id: METC 23-049, briefTitle: The Impact of Low Level Laser Treatment on Skeletal Muscle and Skin Tissue, acronym: LASER, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-08-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Maastricht University Medical Center, class: OTHER, descriptionModule briefSummary: Rationale: Low level laser therapy, or photobiomodulation, is getting more attention as a non-invasive treatment strategy for numerous conditions. Phototherapy has been applied for more than 40 years for the treatment of musculoskeletal and neurological conditions. Low level laser therapy generally applies red or near-infrared lasers with a wavelength between 600 and 1000 nm and low power wattage from 5 to 500 mW and a power density between 1 and 5 W/cm2. The laser light is absorbed by the skin without thermal damage and penetrates deeply into tissues where it is supposed to induce its physiological effects at the cellular level. Laser therapy has been hypothesized to stimulate mitochondrial respiration, increase tissue oxygenation, and support tissue regeneration. Despite supportive research data on in vitro cell and in vivo animal data, there are surprisingly few data on the proposed impact of low level laser treatment (LLLT) on tissue metabolism in vivo in humans.Objective: To assess the impact of acute laser treatment on muscle tissue mitochondrial respiration in vivo in healthy, young adults. Secondary objectives include the in vivo assessment of cellular energy, anabolic, angiogenic and inflammatory pathways, along with enzyme activity within muscle and skin.Study design: Within-subject study.Study population: 12 healthy (BMI 18.5-30 kg/m2) young (age: 18-35 y) adults (6 men and 6 women).Intervention: One leg of the subjects will receive LLLT, while the other leg will receive no treatment. After the treatment muscle and skin biopsy samples will be taken from both legs.Main study parameters/endpoints: The primary outcome will be mitochondrial respiration of the LLLT treated and non-treated leg based on muscle samples. Secondary study parameters are muscle and skin gene expression, protein signalling and enzyme activity., conditionsModule conditions: Muscles Metabolism, conditions: Skin Metabolism, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Within-subject study, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: DOUBLE, maskingDescription: One let will receive the laser therapy, the other one will get a sham laser. The person analyzing the samples will be blinded to legs., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 16, type: ESTIMATED, armsInterventionsModule interventions name: Laser therapy, interventions name: Sham, outcomesModule primaryOutcomes measure: Muscle mitochondrial respiration, secondaryOutcomes measure: Gene expression (mRNA) via real-time PCR, secondaryOutcomes measure: Protein expression via western blotting, secondaryOutcomes measure: Skin mitochondrial respiration, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Maastricht University Medical Centre, status: RECRUITING, city: Maastricht, country: Netherlands, contacts name: Luc JC van Loon, PhD, role: CONTACT, phone: +31-43-3881397, email: l.vanloon@maastrichtuniversity.nl, geoPoint lat: 50.84833, lon: 5.68889, hasResults: False