Muscles MetabolismLASERNCT06330363
The Impact of Low Level Laser Treatment on Skeletal Muscle and Skin Tissue
A study testing Laser therapy in people with Muscles Metabolism and Skin Metabolism, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscles Metabolism, Skin Metabolism
- What is being tested?
- Laser therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Apr 2024to 4 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female sex
- Aged between 18 and 35 y inclusive
- BMI between 18.5 and 30 kg/m2
Who cannot join
- Participating in a structured (progressive) exercise program or >4h of vigorous physical activity per week.
- Smoking regularly (i.e. >5 cigarettes/week)
- Pregnancy
- Hormonal replacement therapy
- Diagnosed musculoskeletal disorders
- Diagnosed metabolic disorders (e.g. diabetes)
Show all 9Show fewer
- Diagnosed skin disorders
- Use of any medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories).
- Chronic use of anti-coagulants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Low Level Laser Treatment on Skeletal Muscle and Skin Tissue Mitochondrial Respiration, Metabolic Activity and Signalling in Vivo in Humans
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.
Read more
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.
Read the detailed description
The present study utilizes an acute within-subject design in healthy young adult participants. In total, 12 healthy young adults (6 men and 6 women) will participate in the study. Participants' legs will be randomly assigned to low level laser treatment or no treatment (Figure 1). Each participant will participate in a screening session (~1 h) and 1 experimental test day (~1.5 h). Figure 1 shows a graphical illustration of the study overview.
In total, 12 healthy (BMI 18.5-30 kg/m2) young (age: 18-35 y) males and females will participate in the present study. The nature and the risks of the experimental procedures will be explained to all subjects before their informed consent will be obtained. All subjects will be recruited through social media and advertisements on dedicated bulletin boards within the MUMC+ buildings and local shops will be used.
Each subject will participate in an experimental trial lasting ~1.5 h. Subjects will be instructed to arrive at the university at 9:00 AM in an overnight fasted and rested state, meaning that participants are not allowed to eat and drink (except for water) from 21:00 the night prior to the experimental trial. They will be instructed to come to the university by car or public transportation. After the subjects arrive at the University, we will ask them to put on their shorts, determine their body mass, and assign them to a bed. Subjects will rest in a supine position for 10 minutes. Thereafter, the LLLT will be applied on one leg, which will be randomized. The other leg will receive no treatment. Immediately after the treatment muscle biopsies will be taken from the m. vastus lateralis of both legs. The muscle biopsy from the treated leg will be sampled 15 min after finishing the LLLT. Additionally, skin biopsies will be taken from the same area. The skin biopsy of the treated leg will be collected 20 min after finishing the LTT. During the test day, a total of 2 muscle and skin biopsies will be taken, 1 biopsy from each leg. Here each skin biopsy sampling consists of 2 4 mm punch biopsies. The time between finishing the LLLT and collection of the tissue samples will be noted.
Primary objective: To assess the impact of acute laser treatment on muscle tissue mitochondrial respiration in vivo in healthy, young adults.
Secondary objective: To assess the impact of acute laser treatment on muscle cellular energy, anabolic, angiogenic and inflammatory pathways, along with enzyme activity.
Tertiary objectives: To assess the impact of acute laser treatment on skin cellular energy, anabolic, angiogenic and inflammatory pathways, along with enzyme activity.
Hypothesis:
- It is hypothesized that muscle mitochondrial respiration will be higher following low level laser treatment.
- It is hypothesized that muscle gene expression, protein signalling and enzyme activity will be higher following low level laser treatment.
- It is hypothesized that skin gene expression, protein signalling and enzyme activity will be higher following low level laser treatment.
- Conditions
- Muscles Metabolism, Skin Metabolism
- Being tested
- Laser therapy, Sham
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser therapyOther
The Cube plus30 from Eltech K-Laser s.r.l. (Italy, www.k-laser.com) will be used for LLLT. The laser devices from Eltech K-Laser s.r.l. have been used in (clinical) studies with a variety in patient populations (38-41) and clinical practice (https://resources.k-laser.com.au/medical-laser-clinical-applications). The device is a registered medical device in the EU confirmed by Kiwa Cermet Italia.
ShamOther
Also called Light
The laser device has sham light option that will be used.
| Study group | Role | What they receive |
|---|---|---|
| LLLT | Experimental | The LLLT will be performed using a Cube plus30 (Eltech K-Laser s.r.l., Italy). Settings will be based on manufacturer's guidelines for skin and deep tissue stimulation. The LLLT will take 25 min, with 3x5 min of treatment separated by 5 min of rest. In total 16800 J in form of light energy will be applied (3 x 5600 J). All 4 available wavelength will be used (660, 800, 905 and 970 nm). The randomization procedure to allocate the treated leg will occur via a random-number generator stratified for sex (www.randomization.com) performed by an independent researcher of the research group. During the laser treatment protective goggles (K-Laser Protective Goggles, Eltech K-Laser s.r.l.) need to be worn and will therefore be provided. LLLT will only be applied by trained personal. Receives: Other: Laser therapy |
| Sham | Sham comparator | Sham laser based on the same laser device which emitts only light. Receives: Other: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle mitochondrial respiration
Maximal complex I+II-linked mitochondrial respiration of muscle tissue, expressed as oxygen consumption (JO2) in units of pmol/sec/mg dry weight muscle. Oxygen consumption will be monitored in an Oroboros O2K Oxygraph (Innsbruck, Austria) in the presence of pyruvate, malate, ADP, glutamate, and succinate, providing substrates to maximally stimulate complex I+II-linked respiration.
Measured: only one time point, immediately after the intervention
Secondary outcomes (3)
Gene expression (mRNA) via real-time PCR
of muscle and skin
Measured: only one time point, immediately after the intervention
Protein expression via western blotting
of muscle and skin
Measured: only one time point, immediately after the intervention
Skin mitochondrial respiration
Maximal complex I+II-linked mitochondrial respiration of skin tissue, expressed as oxygen consumption (JO2) in units of pmol/sec/mg dry weight muscle. Oxygen consumption will be monitored in an Oroboros O2K Oxygraph (Innsbruck, Austria) in the presence of pyruvate, malate, ADP, glutamate, and succinate, providing substrates to maximally stimulate complex I+II-linked respiration.
Measured: only one time point, immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start1 Apr 2024
- Primary completion4 Nov 2024
- Study completion4 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscles MetabolismStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Within-subject study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06330363
- Sponsor's protocol ID
- METC 23-049
- Acronym
- LASER
- Status last verified
- Dec 2024
- First submitted
- 11 Mar 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Low Level Laser Treatment on Skeletal Muscle and Skin Tissue Mitochondrial Respiration, Metabolic Activity and Signalling in Vivo in Humans
- ClinicalTrials.gov ID
- NCT06330363
- Acronym / sponsor ID
- LASER / METC 23-049
- Conditions
- Muscles Metabolism, Skin Metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 4 Nov 2024 (actual)
- Study completion
- 4 Nov 2024 (actual)
- First posted
- 26 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The present study utilizes an acute within-subject design in healthy young adult participants. In total, 12 healthy young adults (6 men and 6 women) will participate in the study. Participants' legs will be randomly assigned to low level laser treatment or no treatment (Figure 1). Each participant will participate in a screening session (~1 h) and 1 experimental test day (~1.5 h). Figure 1 shows a graphical illustration of the study overview.
In total, 12 healthy (BMI 18.5-30 kg/m2) young (age: 18-35 y) males and females will participate in the present study. The nature and the risks of the experimental procedures will be explained to all subjects before their informed consent will be obtained. All subjects will be recruited through social media and advertisements on dedicated bulletin boards within the MUMC+ buildings and local shops will be used.
Each subject will participate in an experimental trial lasting ~1.5 h. Subjects will be instructed to arrive at the university at 9:00 AM in an overnight fasted and rested state, meaning that participants are not allowed to eat and drink (except for water) from 21:00 the night prior to the experimental trial. They will be instructed to come to the university by car or public transportation. After the subjects arrive at the University, we will ask them to put on their shorts, determine their body mass, and assign them to a bed. Subjects will rest in a supine position for 10 minutes. Thereafter, the LLLT will be applied on one leg, which will be randomized. The other leg will receive no treatment. Immediately after the treatment muscle biopsies will be taken from the m. vastus lateralis of both legs. The muscle biopsy from the treated leg will be sampled 15 min after finishing the LLLT. Additionally, skin biopsies will be taken from the same area. The skin biopsy of the treated leg will be collected 20 min after finishing the LTT. During the test day, a total of 2 muscle and skin biopsies will be taken, 1 biopsy from each leg. Here each skin biopsy sampling consists of 2 4 mm punch biopsies. The time between finishing the LLLT and collection of the tissue samples will be noted.
Primary objective: To assess the impact of acute laser treatment on muscle tissue mitochondrial respiration in vivo in healthy, young adults.
Secondary objective: To assess the impact of acute laser treatment on muscle cellular energy, anabolic, angiogenic and inflammatory pathways, along with enzyme activity.
Tertiary objectives: To assess the impact of acute laser treatment on skin cellular energy, anabolic, angiogenic and inflammatory pathways, along with enzyme activity.
Hypothesis:
- It is hypothesized that muscle mitochondrial respiration will be higher following low level laser treatment.
- It is hypothesized that muscle gene expression, protein signalling and enzyme activity will be higher following low level laser treatment.
- It is hypothesized that skin gene expression, protein signalling and enzyme activity will be higher following low level laser treatment.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Within-subject study
| Arm | Type | Receives |
|---|---|---|
| LLLT | Experimental | Other: Laser therapyThe LLLT will be performed using a Cube plus30 (Eltech K-Laser s.r.l., Italy). Settings will be based on manufacturer's guidelines for skin and deep tissue stimulation. The LLLT will take 25 min, with 3x5 min of treatment separated by 5 min of rest. In total 16800 J in form of light energy will be applied (3 x 5600 J). All 4 available wavelength will be used (660, 800, 905 and 970 nm). The randomization procedure to allocate the treated leg will occur via a random-number generator stratified for sex (www.randomization.com) performed by an independent researcher of the research group. During the laser treatment protective goggles (K-Laser Protective Goggles, Eltech K-Laser s.r.l.) need to be worn and will therefore be provided. LLLT will only be applied by trained personal. |
| Sham | Sham comparator | Other: ShamSham laser based on the same laser device which emitts only light. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male or female sex
- Aged between 18 and 35 y inclusive
- BMI between 18.5 and 30 kg/m2
Key exclusion criteria (9 listed)
- Participating in a structured (progressive) exercise program or >4h of vigorous physical activity per week.
- Smoking regularly (i.e. >5 cigarettes/week)
- Pregnancy
- Hormonal replacement therapy
- Diagnosed musculoskeletal disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser therapyThe Cube plus30 from Eltech K-Laser s.r.l. (Italy, www.k-laser.com) will be used for LLLT. The laser devices from Eltech K-Laser s.r.l. have been used in (clinical) studies with a variety in patient populations (38-41) and clinical practice (https://resources.k-laser.com.au/medical-laser-clinical-applications). The device is a registered medical device in the EU confirmed by Kiwa Cermet Italia. | Other | LLLT |
| ShamAlso: LightThe laser device has sham light option that will be used. | Other | Sham |
Primary outcome
Muscle mitochondrial respiration
Time frame: only one time point, immediately after the intervention
Maximal complex I+II-linked mitochondrial respiration of muscle tissue, expressed as oxygen consumption (JO2) in units of pmol/sec/mg dry weight muscle. Oxygen consumption will be monitored in an Oroboros O2K Oxygraph (Innsbruck, Austria) in the presence of pyruvate, malate, ADP, glutamate, and succinate, providing substrates to maximally stimulate complex I+II-linked respiration.
3 secondary outcomes
Gene expression (mRNA) via real-time PCR
Time frame: only one time point, immediately after the intervention
Protein expression via western blotting
Time frame: only one time point, immediately after the intervention
Skin mitochondrial respiration
Time frame: only one time point, immediately after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Muscles Metabolism
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Not yet recruiting
Comparison of Functional Inspiratory Muscle Training and Combined Exercise Training in Individuals With Type 2 Diabetes
Type 2 Diabetes Mellitus
Active, not recruitingObservational study
CFTR Modulator Effects on Bone and Muscle in Adults With Cystic Fibrosis
Cystic Fibrosis, Bone Loss
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser therapy in people with Muscles Metabolism and Skin Metabolism, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle mitochondrial respiration (time frame: only one time point, immediately after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.