- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04676958
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
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
80
Phase
- 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
-
-
-
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
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 |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
380 mg capsule/day micro-crystalline cellulose
|
Micro-crystalline cellulose
|
Active Comparator: Vitamin K2
380 mg capsule/day micro-crystalline cellulose including 240ug/day Vitamin K2
|
Vitamin K2
|
What is the study measuring?
Primary Outcome Measures
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
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
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
Collaborators
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)
April 1, 2021
Primary Completion (Actual)
July 1, 2023
Study Completion (Actual)
July 1, 2023
Study Registration Dates
First Submitted
November 24, 2020
First Submitted That Met QC Criteria
December 18, 2020
First Posted (Actual)
December 21, 2020
Study Record Updates
Last Update Posted (Actual)
November 28, 2023
Last Update Submitted That Met QC Criteria
November 26, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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