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viTAmin K2 and rEcOVery From ExeRcise (TAKEOVER)

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ClinicalTrials.gov Identifier: NCT04676958
Recruitment Status : Recruiting
First Posted : December 21, 2020
Last Update Posted : May 25, 2021
Sponsor:
Collaborator:
Kappa Bioscience
Information provided by (Responsible Party):
Stuart Gray, University of Glasgow

Study Description
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Brief Summary:
The aim of the current study, therefore, is to investigate the effects of vitamin K2 supplementation on the physiological responses to an acute bout of resistance exercise.

Condition or disease Intervention/treatment Phase
Inflammation Oxidative Stress Vitamin K Exercise Strength Recovery Dietary Supplement: Vitamin K2 Dietary Supplement: Micro-crystalline cellulose Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Vitamin K2 on Recovery From Muscle Damaging Exercise in Young and Older Adults
Actual Study Start Date : April 1, 2021
Estimated Primary Completion Date : October 1, 2022
Estimated Study Completion Date : October 1, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
380 mg capsule/day micro-crystalline cellulose
 Dietary Supplement: Micro-crystalline cellulose
Micro-crystalline cellulose
Active Comparator: Vitamin K2
380 mg capsule/day micro-crystalline cellulose including 240ug/day Vitamin K2
 Dietary Supplement: Vitamin K2
Vitamin K2


Outcome Measures
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Primary Outcome Measures :
  1. Change in post exercise recovery of muscle strength [ Time Frame: Change from baseline to 12 weeks ]
    Muscle strength (MVC) of the knee extensor muscles will be measured before and after (3h, 24h, 48h, 72h) an acute bout of resistance exercise


Secondary Outcome Measures :
  1. Change in pain free range of motion during knee extension exercise [ Time Frame: Change from baseline to 12 weeks ]
    The range of motion which is pain free will be measured during knee extension using a goniometer before and after (3h, 24h, 48h, 72h) an acute bout of resistance exercise

  2. Change in post exercise recovery of functional abilities [ Time Frame: Change from baseline to 12 weeks ]
    Time to complete 5 chair rises will be measured before and after (3h, 24h, 48h, 72h) an acute bout of resistance exercise

  3. Change in post exercise recovery of sEMG activity [ Time Frame: Change from baseline to 12 weeks ]
    Quadriceps muscle sEMG will be measured before and after (3h, 24h, 48h, 72h) an acute bout of resistance exercise

  4. Change in post exercise interleukin-6 [ Time Frame: Change from baseline to 12 weeks ]
    Circulating interleukin-6 will be measured before and after (3h, 24h, 48h, 72h) an acute bout of resistance exercise

  5. Change in post exercise peroxiredoxin 3 redox state [ Time Frame: Change from baseline to 12 weeks ]
    Circulating peroxiredoxin 3 redox state will be measured before and after (3h, 24h, 48h, 72h) an acute bout of resistance exercise

  6. Change in vitamin K levels [ Time Frame: Change from baseline to 12 weeks ]
    Vitamin K will be measured in baseline and 12 week samples

  7. Change in Carboxylated Osteocalcin levels [ Time Frame: Change from baseline to 12 weeks ]
    Carboxylated Osteocalcin will be measured in baseline and 12 week samples

  8. Change in uncarboxylated Osteocalcin levels [ Time Frame: Change from baseline to 12 weeks ]
    uncarboxylated Osteocalcin will be measured in baseline and 12 week samples

  9. Change in carboxylated matrix gla-protein levels [ Time Frame: Change from baseline to 12 weeks ]
    carboxylated matrix gla-protein will be measured in baseline and 12 week samples

  10. Change in dephosphorylated-uncarboxylated matrix gla-protein levels [ Time Frame: Change from baseline to 12 weeks ]
    dephosphorylated-uncarboxylated matrix gla-protein will be measured in baseline and 12 week samples

  11. Change in post exercise F2 isoprostanes [ Time Frame: Change from baseline to 12 weeks ]
    Circulating F2 isoprostanes will be measured before and after (3h, 24h, 48h, 72h) an acute bout of resistance exercise


Other Outcome Measures:
  1. Change in lean mass [ Time Frame: Change from baseline to 12 weeks ]
    Change in lean mass

  2. Change in blood glucose [ Time Frame: Change from baseline to 12 weeks ]
    Change in blood glucose

  3. Change in blood lipids [ Time Frame: Change from baseline to 12 weeks ]
    Change in blood lipids

  4. Change in plasma insulin [ Time Frame: Change from baseline to 12 weeks ]
    Change in plasma insulin

  5. Change in fat mass [ Time Frame: Change from baseline to 12 weeks ]
    Change in fat mass

  6. Change in muscle thickness [ Time Frame: Change from baseline to 12 weeks ]
    Change in muscle thickness

  7. Change in exercise substrate utilisation [ Time Frame: Change from baseline to 12 weeks ]
    Energy expenditure, carbodhydrate and fat oxidation during treadmill walking


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participant is able and willing to sign the Informed Consent From
  • No plans to change lifestyle (activity and nutrition) during the study period
  • Older group (n=40): 65 years of age or older.
  • Younger group (n=40): Aged 18-40 years

Exclusion Criteria:

  • Not currently, or in the last year, participating in more than 1h per week of vigorous aerobic physical activity or any resistance exercise
  • BMI > 30 kg/m2
  • diabetes
  • severe cardiovascular disease
  • seizure disorders
  • liver disease
  • uncontrolled hypertension (>150/90mmHg at baseline measurement)
  • cancer or cancer that has been in remission <5 years
  • ambulatory impairments which would limit ability to perform assessments of muscle function
  • dementia
  • currently taking Vitamin K2 supplements
  • currently taking Vitamin K antagonists/anticoagulants (e.g. warfarin)
  • current smoking
  • history of drug abuse
  • taking medication known to affect muscle (e.g. steroids).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04676958


Locations
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United Kingdom
University of Glasgow Recruiting
Glasgow, United Kingdom, G12 8TA
Contact: Dr H Lithgow, PhD    0141 330 2569    hannah.lithgow@glasgow.ac.uk   
Stuart Robert Gray Recruiting
Glasgow, United Kingdom
Contact: Stuart R Gray    01413302569    stuart.gray@glasgow.ac.uk   
Contact    01413302569 ext Gray    stuart.gray@glasgow.ac.uk   
Principal Investigator: Stuart R Gray, PhD         
Sponsors and Collaborators
University of Glasgow
Kappa Bioscience
More Information
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Responsible Party: Stuart Gray, Senior Lecturer, University of Glasgow
ClinicalTrials.gov Identifier: NCT04676958    
Other Study ID Numbers: 200190189
First Posted: December 21, 2020    Key Record Dates
Last Update Posted: May 25, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes
Vitamin K
Vitamin K 2
Vitamins
Micronutrients
 Physiological Effects of Drugs
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants