viTAmin K2 and rEcOVery From ExeRcise (TAKEOVER)

November 26, 2023 updated by: Stuart Gray, University of Glasgow

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Glasgow, United Kingdom, G12 8TA
        • University of Glasgow
      • Glasgow, United Kingdom
        • Stuart Robert Gray

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Change from baseline to 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Change from baseline to 12 weeks
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
Change from baseline to 12 weeks
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
Change from baseline to 12 weeks
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
Change from baseline to 12 weeks
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
Change from baseline to 12 weeks
Change in vitamin K levels
Time Frame: Change from baseline to 12 weeks
Vitamin K will be measured in baseline and 12 week samples
Change from baseline to 12 weeks
Change in Carboxylated Osteocalcin levels
Time Frame: Change from baseline to 12 weeks
Carboxylated Osteocalcin will be measured in baseline and 12 week samples
Change from baseline to 12 weeks
Change in uncarboxylated Osteocalcin levels
Time Frame: Change from baseline to 12 weeks
uncarboxylated Osteocalcin will be measured in baseline and 12 week samples
Change from baseline to 12 weeks
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
Change from baseline to 12 weeks
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
Change from baseline to 12 weeks
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
Change from baseline to 12 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in lean mass
Time Frame: Change from baseline to 12 weeks
Change in lean mass
Change from baseline to 12 weeks
Change in blood glucose
Time Frame: Change from baseline to 12 weeks
Change in blood glucose
Change from baseline to 12 weeks
Change in blood lipids
Time Frame: Change from baseline to 12 weeks
Change in blood lipids
Change from baseline to 12 weeks
Change in plasma insulin
Time Frame: Change from baseline to 12 weeks
Change in plasma insulin
Change from baseline to 12 weeks
Change in fat mass
Time Frame: Change from baseline to 12 weeks
Change in fat mass
Change from baseline to 12 weeks
Change in muscle thickness
Time Frame: Change from baseline to 12 weeks
Change in muscle thickness
Change from baseline to 12 weeks
Change in exercise substrate utilisation
Time Frame: Change from baseline to 12 weeks
Energy expenditure, carbodhydrate and fat oxidation during treadmill walking
Change from baseline to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Glasgow

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Kappa Bioscience

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 24, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 21, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 28, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 200190189

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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