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Completed

NCT Number: NCT04676958

viTAmin K2 and rEcOVery From ExeRcise

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.

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Key information

Conditions

Inflammation Behavior Exercise Motor Activity Oxidative Stress Pathologic Processes Pathological Conditions, Signs and Symptoms Recovery Strength Vitamin K

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stuart Robert Gray, Glasgow, United Kingdom

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

vitamin K2

Dietary Supplement

Vitamin K2

Micro-crystalline cellulose

Dietary Supplement

Micro-crystalline cellulose

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Glasgow

Other

Collaborators

  • Kappa Bioscience

Registry information

Official study title

Effects of Vitamin K2 on Recovery From Muscle Damaging Exercise in Young and Older Adults

Acronym: TAKEOVER

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 21, 2020
Registry last updated
Nov 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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