Muscle AtrophyRecoveryNCT05161975
Vitamin K2 Supplements for Muscle Recovery
A study testing Vitamin K2 in people with Muscle Atrophy and Cachexia, run by Lithuanian Sports University at 2 sites in Lithuania.
Trial summary
Ankle injury is one of the most common injuries which can have long term consequences. Ankle immobilization is often applied for up to six weeks to ensure healing of the soft tissue and fractured bones after such an injury. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Atrophy, Cachexia
- What is being tested?
- Vitamin K2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesLithuania
- Study dates
- 15 Dec 2021to 31 Dec 2023
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-60 years of age;
- Lives in Lithuania;
- Able and willing to give informed written consent to participate in the study;
- Recent (24 h before volunteering for the study) ankle injury requiring 6-week ankle immobilization;
- Exercise training program during 6-week recovery is recommended.
Who cannot join
- Body mass index (BMI) is greater than 30 kg / m2;
- Diabetes complicates cardiovascular diseases,
- Liver disease;
- Blood pressure is greater than 150/90mmHg during the first measurement;
- Incidences of consciousness loss;
- Cancer;
Show all 12Show fewer
- Dementia;
- Other injuries that affect lower limb muscles;
- Use of anticoagulant drugs;
- Smoking;
- Drug abuse;
- Using drugs that affect muscle function (steroids).
Trial locations and contacts
2 sites in 1 country.
Tomas Kadusauskas, M.D. contact
Lithuania2 sites
Lithuanian Sports University
Kaunas, 44221
Aivaras Ratkevicius, Dr., +37069009974, aivaras.ratkevicius@lsu.lt
LSMU Kauno ligonine
Kaunas, 47144
Tomas Kadusauskas, M.D, +37069849471, tomas.kadusauskas@stud.lsu.lt
About this study
Official title: Effects of Vitamin K2 Supplements on Recovery of Lower Limb Muscle Function After Ankle Injury in Adults
Ankle injury is one of the most common injuries which can have long term consequences. Ankle immobilization is often applied for up to six weeks to ensure healing of the soft tissue and fractured bones after such an injury. This causes significant wasting of the lower leg muscles driven by inflammation and oxidative stress. The rate of muscle atrophy and recovery after injury varies significantly by sex and age. These differences might be linked to changes in gene and protein expression associated with regulation of protein synthesis and proteolysis. Interventions that reduce the deleterious effects of ankle injury as well as understanding of the underlying mechanisms could be particularly useful in promotion of healthy ageing. Vitamin K includes a group of structurally related compounds. Phylloquinone (vitamin K1) and menaquinones (vitamin K2s) of which MK-4 and MK-7 are the most important. Vitamin K2 has anti-inflammatory and antioxidant effects and thus may be effective in reducing muscle atrophy during limb immobilization and improving recovery of muscle function after injury. This aim of the current study is to investigate if vitamin K2 supplements can ameliorate muscle atrophy and improve recovery of muscle function after ankle injury. The investigators will study younger (18-39 year old) and older (40-60 year old) men and women to assess effects of sex and age.
Read the detailed description
Muscle weakness is associated with impaired quality of life, increased risk of falling, disability and premature mortality. Whilst ageing results in a progressive decline, even short periods of low physical activity can result in significant deterioration of muscle function and metabolic health. One such period of very low activity can occur following illness or injury. This can lead to decrease in lower limb muscle mass and strength. Muscle exercise training promotes recovery of skeletal muscles after injury though improvements vary between individuals and appear to decrease with age. Strategies to retard loss of muscle mass and function during inactivity are, thus, of critical importance in understanding of the mechanisms underlying such effects.
Vitamin K includes a group of structurally related compounds named phylloquinone (vitamin K1) and menaquinones (vitamin K2s) of which MK-4 and MK-7 are the most important. Vitamin K is an essential cofactor for gamma carboxylation, required for the effective function of a range of proteins and has been linked to chronic disease and inflammation. Muscle cell studies suggest that vitamin K2 increases expression of myogenic transcription factors such as MyoD and promotes muscle cell proliferation. There are 20 described vitamin K dependent proteins (VKDPs). It is also known that vitamin K2 inhibits the activation of NFkB independently of gamma-carboxylation. This prevents nuclear entry of NFkB and therefore, consequently, vitamin K2 inhibits NFkB to interact with its nuclear receptors. In addition, Vitamin K2 can function as an electron carrier in mitochondria, and therefore play an inhibitory role on oxidative stress and release of ROS. There is, therefore, a strong rationale for investigating the effects of vitamin K2 during ankle immobilisation. The aim of the study is to investigate the effects of vitamin K2 on skeletal muscles after ankle injury and in the recovery process.
- Conditions
- Muscle Atrophy, Cachexia
- Being tested
- Vitamin K2
- Keywords
- Cachexia; Insulin Resistance; Muscle Weakness; Exercise training
- Medical subject headings
- Muscular Atrophy, Cachexia, Insulin Resistance, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin K2Dietary supplement
Volunteers will be randomly assigned to vitamin K2 or placebo group and consume one tablet of the food supplement per day.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Food supplement tablets do not contain vitamin K2 Receives: Dietary Supplement: Vitamin K2 |
| Vitamin K2 | Experimental | Food supplement tablets contain vitamin K2 Receives: Dietary Supplement: Vitamin K2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle thickness
Transverse images of medial and lateral gastrocnemius, soleus and tibialis anterior muscles will be obtained using B-mode ultrasonography with a 10-15 MHz transducer.
Measured: 12 weeks.
Muscle strength
Plantar flexor and extensor strength will be measured using isokinetic dynamometer (Biodex System 3 Biodex Medical Systems, Inc., Shirley, NY, USA).
Measured: 12 weeks.
Vitamin K2 status
Blood samples will be taken and plasma levels of vitamin K2 will be assessed.
Measured: 12 weeks.
Secondary outcomes (4)
Cytokine profile
Blood samples will be taken and ELISA assays for insulin, myostatin, TGF-β2, IGF-1, IL-1b, IL-6 and TNF-alpha will be performed
Measured: 12 weeks.
Gene expression profile
Biopsies of soleus and gastrocnemius muscles will be taken. The mRNA levels of p62, Atrogin 1, MuRF 1, LC3b and Gapdh were assessed using SYBR Green (#4367659, Thermo Fisher Scientific) assay for quantitative PCR.
Measured: 12 weeks.
Protein expression profile
Biopsies of soleus and gastrocnemius muscles will be taken. Western blotting will be carried to examine signalling pathways that control protein synthase (Akt-mTOR-p70s6k).
Measured: 12 weeks.
Metabolic enzyme activity
Biopsies of soleus and gastrocnemius muscles will be taken. Enzyme assays for citrate synthase (CS), succinate dehydrogenase (SDH), β-hydroxyacyl-coenzyme dehydrogenase (HAD) and other metabolic enzyme will be carried out.
Measured: 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start15 Dec 2021 (estimated)
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Muscle AtrophyStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We will carry out a double-blinded, randomized, placebo controlled clinical trial. We will recruit 18-60 years old men and women who have sustained ankle injury and arrived to LSMU Kauno ligonine for treatment. The volunteers will be randomly assigned to the vitamin K2 (MK-7, 330 micrograms) or placebo group. We expect to see 3-mm difference in muscle thickness between the groups. The gastrocnemius muscle thickness is reported to be 17.49 ± 3.81 mm (Kirmaci et al. 2021). Thus, 25 volunteers in each group are needed (statistical power = 80%, p \< 0.05) for the study. We will recruit 30 volunteers into each group as some volunteers might drop out of the study. We will recruit equal number of 18-39 year old and 40-59 year olds into both groups (n =15 each) to minimize effects of age.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lithuanian Sports University
- Sponsor type
- University, hospital or other
- Collaborators
- Kappa Bioscience AS, LSMU Kauno ligonine
- Responsible party
- Sponsor
- Investigators
- Aivaras Ratkevicius, Dr., Principal investigator, Lithuanian Sports University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05161975
- Sponsor's protocol ID
- LithuanianSportsU-7
- Acronym
- Recovery
- Status last verified
- Nov 2021
- First submitted
- 11 Nov 2021
- Last updated
- 17 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wolfe RR. The underappreciated role of muscle in health and disease. Am J Clin Nutr. 2006 Sep;84(3):475-82. doi: 10.1093/ajcn/84.3.475.
PubMed 16960159Celis-Morales CA, Welsh P, Lyall DM, Steell L, Petermann F, Anderson J, Iliodromiti S, Sillars A, Graham N, Mackay DF, Pell JP, Gill JMR, Sattar N, Gray SR. Associations of grip strength with cardiovascular, respiratory, and cancer outcomes and all cause mortality: prospective cohort study of half a million UK Biobank participants. BMJ. 2018 May 8;361:k1651. doi: 10.1136/bmj.k1651.
PubMed 29739772Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.
PubMed 30312372Krogh-Madsen R, Thyfault JP, Broholm C, Mortensen OH, Olsen RH, Mounier R, Plomgaard P, van Hall G, Booth FW, Pedersen BK. A 2-wk reduction of ambulatory activity attenuates peripheral insulin sensitivity. J Appl Physiol (1985). 2010 May;108(5):1034-40. doi: 10.1152/japplphysiol.00977.2009. Epub 2009 Dec 31.
PubMed 20044474Juto H, Nilsson H, Morberg P. Epidemiology of Adult Ankle Fractures: 1756 cases identified in Norrbotten County during 2009-2013 and classified according to AO/OTA. BMC Musculoskelet Disord. 2018 Dec 13;19(1):441. doi: 10.1186/s12891-018-2326-x.
PubMed 30545314Psatha M, Wu Z, Gammie FM, Ratkevicius A, Wackerhage H, Lee JH, Redpath TW, Gilbert FJ, Ashcroft GP, Meakin JR, Aspden RM. A longitudinal MRI study of muscle atrophy during lower leg immobilization following ankle fracture. J Magn Reson Imaging. 2012 Mar;35(3):686-95. doi: 10.1002/jmri.22864. Epub 2011 Nov 1.
PubMed 22045592Stevens JE, Pathare NC, Tillman SM, Scarborough MT, Gibbs CP, Shah P, Jayaraman A, Walter GA, Vandenborne K. Relative contributions of muscle activation and muscle size to plantarflexor torque during rehabilitation after immobilization. J Orthop Res. 2006 Aug;24(8):1729-36. doi: 10.1002/jor.20153.
PubMed 16779833Psatha M, Wu Z, Gammie F, Ratkevicius A, Wackerhage H, Redpath TW, Gilbert FJ, Meakin JR, Aspden RM. Age-related changes in the effects of strength training on lower leg muscles in healthy individuals measured using MRI. BMJ Open Sport Exerc Med. 2017 Jul 20;3(1):e000249. doi: 10.1136/bmjsem-2017-000249. eCollection 2017.
PubMed 28761720Rosa-Caldwell ME, Lim S, Haynie WS, Jansen LT, Westervelt LC, Amos MG, Washington TA, Greene NP. Altering aspects of mitochondrial quality to improve musculoskeletal outcomes in disuse atrophy. J Appl Physiol (1985). 2020 Dec 1;129(6):1290-1303. doi: 10.1152/japplphysiol.00407.2020. Epub 2020 Sep 17.
PubMed 32940556Sitnick M, Bodine SC, Rutledge JC. Chronic high fat feeding attenuates load-induced hypertrophy in mice. J Physiol. 2009 Dec 1;587(Pt 23):5753-65. doi: 10.1113/jphysiol.2009.180174. Epub 2009 Oct 12.
PubMed 19822547Hotamisligil GS. Foundations of Immunometabolism and Implications for Metabolic Health and Disease. Immunity. 2017 Sep 19;47(3):406-420. doi: 10.1016/j.immuni.2017.08.009.
PubMed 28930657Laufs U, Wassmann S, Czech T, Munzel T, Eisenhauer M, Bohm M, Nickenig G. Physical inactivity increases oxidative stress, endothelial dysfunction, and atherosclerosis. Arterioscler Thromb Vasc Biol. 2005 Apr;25(4):809-14. doi: 10.1161/01.ATV.0000158311.24443.af. Epub 2005 Feb 3.
PubMed 15692095Meng SJ, Yu LJ. Oxidative stress, molecular inflammation and sarcopenia. Int J Mol Sci. 2010 Apr 12;11(4):1509-26. doi: 10.3390/ijms11041509.
PubMed 20480032Atherton PJ, Greenhaff PL, Phillips SM, Bodine SC, Adams CM, Lang CH. Control of skeletal muscle atrophy in response to disuse: clinical/preclinical contentions and fallacies of evidence. Am J Physiol Endocrinol Metab. 2016 Sep 1;311(3):E594-604. doi: 10.1152/ajpendo.00257.2016. Epub 2016 Jul 5.
PubMed 27382036Shearer MJ, Okano T. Key Pathways and Regulators of Vitamin K Function and Intermediary Metabolism. Annu Rev Nutr. 2018 Aug 21;38:127-151. doi: 10.1146/annurev-nutr-082117-051741. Epub 2018 Jun 1.
PubMed 29856932
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vitamin K2 Supplements on Recovery of Lower Limb Muscle Function After Ankle Injury in Adults
- ClinicalTrials.gov ID
- NCT05161975
- Acronym / sponsor ID
- Recovery / LithuanianSportsU-7
- Conditions
- Muscle Atrophy, Cachexia
- Keywords
- Cachexia; Insulin Resistance; Muscle Weakness; Exercise training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Lithuanian Sports UniversityUniversity, hospital or other
- Collaborators
- Kappa Bioscience AS, LSMU Kauno ligonine
- Study start
- 15 Dec 2021 (estimated)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 17 Dec 2021 (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.
Ankle injury is one of the most common injuries which can have long term consequences. Ankle immobilization is often applied for up to six weeks to ensure healing of the soft tissue and fractured bones after such an injury. This causes significant wasting of the lower leg muscles driven by inflammation and oxidative stress. The rate of muscle atrophy and recovery after injury varies significantly by sex and age. These differences might be linked to changes in gene and protein expression associated with regulation of protein synthesis and proteolysis. Interventions that reduce the deleterious effects of ankle injury as well as understanding of the underlying mechanisms could be particularly useful in promotion of healthy ageing. Vitamin K includes a group of structurally related compounds. Phylloquinone (vitamin K1) and menaquinones (vitamin K2s) of which MK-4 and MK-7 are the most important. Vitamin K2 has anti-inflammatory and antioxidant effects and thus may be effective in reducing muscle atrophy during limb immobilization and improving recovery of muscle function after injury. This aim of the current study is to investigate if vitamin K2 supplements can ameliorate muscle atrophy and improve recovery of muscle function after ankle injury. The investigators will study younger (18-39 year old) and older (40-60 year old) men and women to assess effects of sex and age.
Detailed description
Muscle weakness is associated with impaired quality of life, increased risk of falling, disability and premature mortality. Whilst ageing results in a progressive decline, even short periods of low physical activity can result in significant deterioration of muscle function and metabolic health. One such period of very low activity can occur following illness or injury. This can lead to decrease in lower limb muscle mass and strength. Muscle exercise training promotes recovery of skeletal muscles after injury though improvements vary between individuals and appear to decrease with age. Strategies to retard loss of muscle mass and function during inactivity are, thus, of critical importance in understanding of the mechanisms underlying such effects.
Vitamin K includes a group of structurally related compounds named phylloquinone (vitamin K1) and menaquinones (vitamin K2s) of which MK-4 and MK-7 are the most important. Vitamin K is an essential cofactor for gamma carboxylation, required for the effective function of a range of proteins and has been linked to chronic disease and inflammation. Muscle cell studies suggest that vitamin K2 increases expression of myogenic transcription factors such as MyoD and promotes muscle cell proliferation. There are 20 described vitamin K dependent proteins (VKDPs). It is also known that vitamin K2 inhibits the activation of NFkB independently of gamma-carboxylation. This prevents nuclear entry of NFkB and therefore, consequently, vitamin K2 inhibits NFkB to interact with its nuclear receptors. In addition, Vitamin K2 can function as an electron carrier in mitochondria, and therefore play an inhibitory role on oxidative stress and release of ROS. There is, therefore, a strong rationale for investigating the effects of vitamin K2 during ankle immobilisation. The aim of the study is to investigate the effects of vitamin K2 on skeletal muscles after ankle injury and in the recovery process.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- We will carry out a double-blinded, randomized, placebo controlled clinical trial. We will recruit 18-60 years old men and women who have sustained ankle injury and arrived to LSMU Kauno ligonine for treatment. The volunteers will be randomly assigned to the vitamin K2 (MK-7, 330 micrograms) or placebo group. We expect to see 3-mm difference in muscle thickness between the groups. The gastrocnemius muscle thickness is reported to be 17.49 ± 3.81 mm (Kirmaci et al. 2021). Thus, 25 volunteers in each group are needed (statistical power = 80%, p < 0.05) for the study. We will recruit 30 volunteers into each group as some volunteers might drop out of the study. We will recruit equal number of 18-39 year old and 40-59 year olds into both groups (n =15 each) to minimize effects of age.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Vitamin K2Food supplement tablets do not contain vitamin K2 |
| Vitamin K2 | Experimental | Dietary Supplement: Vitamin K2Food supplement tablets contain vitamin K2 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18-60 years of age;
- Lives in Lithuania;
- Able and willing to give informed written consent to participate in the study;
- Recent (24 h before volunteering for the study) ankle injury requiring 6-week ankle immobilization;
- Exercise training program during 6-week recovery is recommended.
Key exclusion criteria (12 listed)
- Body mass index (BMI) is greater than 30 kg / m2;
- Diabetes complicates cardiovascular diseases,
- Liver disease;
- Blood pressure is greater than 150/90mmHg during the first measurement;
- Incidences of consciousness loss;
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 |
|---|---|---|
| Vitamin K2Volunteers will be randomly assigned to vitamin K2 or placebo group and consume one tablet of the food supplement per day. | Dietary supplement | Placebo, Vitamin K2 |
Primary outcome
Muscle thickness
Time frame: 12 weeks.
Transverse images of medial and lateral gastrocnemius, soleus and tibialis anterior muscles will be obtained using B-mode ultrasonography with a 10-15 MHz transducer.
Muscle strength
Time frame: 12 weeks.
Plantar flexor and extensor strength will be measured using isokinetic dynamometer (Biodex System 3 Biodex Medical Systems, Inc., Shirley, NY, USA).
Vitamin K2 status
Time frame: 12 weeks.
Blood samples will be taken and plasma levels of vitamin K2 will be assessed.
4 secondary outcomes
Cytokine profile
Time frame: 12 weeks.
Gene expression profile
Time frame: 12 weeks.
Protein expression profile
Time frame: 12 weeks.
Metabolic enzyme activity
Time frame: 12 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2021.
- Background: PubMed 16960159Wolfe RR. The underappreciated role of muscle in health and disease. Am J Clin Nutr. 2006 Sep;84(3):475-82. doi: 10.1093/ajcn/84.3.475.
- Background: PubMed 29739772Celis-Morales CA, Welsh P, Lyall DM, Steell L, Petermann F, Anderson J, Iliodromiti S, Sillars A, Graham N, Mackay DF, Pell JP, Gill JMR, Sattar N, Gray SR. Associations of grip strength with cardiovascular, respiratory, and cancer outcomes and all cause mortality: prospective cohort study of half a million UK Biobank participants. BMJ. 2018 May 8;361:k1651. doi: 10.1136/bmj.k1651.
- Background: PubMed 30312372Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.
- Background: PubMed 20044474Krogh-Madsen R, Thyfault JP, Broholm C, Mortensen OH, Olsen RH, Mounier R, Plomgaard P, van Hall G, Booth FW, Pedersen BK. A 2-wk reduction of ambulatory activity attenuates peripheral insulin sensitivity. J Appl Physiol (1985). 2010 May;108(5):1034-40. doi: 10.1152/japplphysiol.00977.2009. Epub 2009 Dec 31.
- Background: PubMed 30545314Juto H, Nilsson H, Morberg P. Epidemiology of Adult Ankle Fractures: 1756 cases identified in Norrbotten County during 2009-2013 and classified according to AO/OTA. BMC Musculoskelet Disord. 2018 Dec 13;19(1):441. doi: 10.1186/s12891-018-2326-x.
- Background: PubMed 22045592Psatha M, Wu Z, Gammie FM, Ratkevicius A, Wackerhage H, Lee JH, Redpath TW, Gilbert FJ, Ashcroft GP, Meakin JR, Aspden RM. A longitudinal MRI study of muscle atrophy during lower leg immobilization following ankle fracture. J Magn Reson Imaging. 2012 Mar;35(3):686-95. doi: 10.1002/jmri.22864. Epub 2011 Nov 1.
- Background: PubMed 16779833Stevens JE, Pathare NC, Tillman SM, Scarborough MT, Gibbs CP, Shah P, Jayaraman A, Walter GA, Vandenborne K. Relative contributions of muscle activation and muscle size to plantarflexor torque during rehabilitation after immobilization. J Orthop Res. 2006 Aug;24(8):1729-36. doi: 10.1002/jor.20153.
- Background: PubMed 28761720Psatha M, Wu Z, Gammie F, Ratkevicius A, Wackerhage H, Redpath TW, Gilbert FJ, Meakin JR, Aspden RM. Age-related changes in the effects of strength training on lower leg muscles in healthy individuals measured using MRI. BMJ Open Sport Exerc Med. 2017 Jul 20;3(1):e000249. doi: 10.1136/bmjsem-2017-000249. eCollection 2017.
- Background: PubMed 32940556Rosa-Caldwell ME, Lim S, Haynie WS, Jansen LT, Westervelt LC, Amos MG, Washington TA, Greene NP. Altering aspects of mitochondrial quality to improve musculoskeletal outcomes in disuse atrophy. J Appl Physiol (1985). 2020 Dec 1;129(6):1290-1303. doi: 10.1152/japplphysiol.00407.2020. Epub 2020 Sep 17.
- Background: PubMed 19822547Sitnick M, Bodine SC, Rutledge JC. Chronic high fat feeding attenuates load-induced hypertrophy in mice. J Physiol. 2009 Dec 1;587(Pt 23):5753-65. doi: 10.1113/jphysiol.2009.180174. Epub 2009 Oct 12.
- Background: PubMed 28930657Hotamisligil GS. Foundations of Immunometabolism and Implications for Metabolic Health and Disease. Immunity. 2017 Sep 19;47(3):406-420. doi: 10.1016/j.immuni.2017.08.009.
- Background: PubMed 15692095Laufs U, Wassmann S, Czech T, Munzel T, Eisenhauer M, Bohm M, Nickenig G. Physical inactivity increases oxidative stress, endothelial dysfunction, and atherosclerosis. Arterioscler Thromb Vasc Biol. 2005 Apr;25(4):809-14. doi: 10.1161/01.ATV.0000158311.24443.af. Epub 2005 Feb 3.
- Individual participant dataSharing planned: No
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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.
Tomas Kadusauskas, M.D. contact
Aivaras Ratkevicius, Dr. principal investigator
Lithuanian Sports University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin K2 in people with Muscle Atrophy and Cachexia, run by Lithuanian Sports University at 2 sites in Lithuania.
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 5 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 17 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Lithuania. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aivaras Ratkevicius, Dr. (+37069009974, aivaras.ratkevicius@lsu.lt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle thickness (time frame: 12 weeks.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05161975, which also lists 21 linked publications.
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 17 Dec 2021.