Vitamin K2 Supplements for Muscle Recovery

NCT05161975 | Unknown

• 1 other identifier: LithuanianSportsU-7
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Muscle Atrophy; Cachexia

Keywords

Cachexia; Insulin Resistance; Muscle Weakness; Exercise training

Outcome Measures

Primary Outcomes (3)

• 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.

  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).

  12 weeks.

• Vitamin K2 status

  Blood samples will be taken and plasma levels of vitamin K2 will be assessed.

  12 weeks.

Secondary Outcomes (4)

• Cytokine profile

  12 weeks.

• Gene expression profile

  12 weeks.

• Protein expression profile

  12 weeks.

• Metabolic enzyme activity

  12 weeks.

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Food supplement tablets do not contain vitamin K2

Dietary Supplement: Vitamin K2

Vitamin K2

EXPERIMENTAL

Food supplement tablets contain vitamin K2

Dietary Supplement: Vitamin K2

Interventions

Vitamin K2 DIETARY_SUPPLEMENT

Volunteers will be randomly assigned to vitamin K2 or placebo group and consume one tablet of the food supplement per day.

Placebo; Vitamin K2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Dementia;
• Other injuries that affect lower limb muscles;
• Use of anticoagulant drugs;
• Smoking;
• Drug abuse;
• Using drugs that affect muscle function (steroids).

Sponsors & Collaborators

• Lithuanian Sports University: lead
• Kappa Bioscience AS: collaborator
• LSMU Kauno ligonine: collaborator

Study Sites (2)

Lithuanian Sports University

Kaunas, 44221, Lithuania

Location

LSMU Kauno ligonine

Kaunas, 47144, Lithuania

Location

Related Publications (21)

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MeSH Terms

Conditions

Muscular Atrophy; Cachexia; Insulin Resistance; Muscle Weakness

Interventions

Vitamin K 2

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Weight Loss; Body Weight Changes; Body Weight; Thinness; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Muscular Diseases; Musculoskeletal Diseases; Pathologic Processes

Intervention Hierarchy (Ancestors)

Vitamin K; Naphthoquinones; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Phytol; Diterpenes; Terpenes; Quinones; Polycyclic Compounds

Study Officials

• Aivaras Ratkevicius, Dr.

  Lithuanian Sports University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aivaras Ratkevicius, Dr.

CONTACT

+37069009974; aivaras.ratkevicius@lsu.lt

Tomas Kadusauskas, M.D.

CONTACT

tomas.kadusauskas@stud.lsu.lt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 11, 2021
• First Posted: December 17, 2021
• Study Start: December 15, 2021
• Primary Completion: October 31, 2023
• Study Completion: December 31, 2023
• Last Updated: December 17, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

LI (2)