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viTAmin K2 and rEcOVery From ExeRcise (TAKEOVER)

Primary Purpose

Inflammation, Oxidative Stress, Vitamin K

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Vitamin K2
Micro-crystalline cellulose
Sponsored by
University of Glasgow
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Inflammation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • University of GlasgowRecruiting
  • Stuart Robert GrayRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Vitamin K2

Arm Description

380 mg capsule/day micro-crystalline cellulose

380 mg capsule/day micro-crystalline cellulose including 240ug/day Vitamin K2

Outcomes

Primary Outcome Measures

Change in post exercise recovery of muscle strength
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

Change in pain free range of motion during knee extension exercise
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 in post exercise recovery of functional abilities
Time to complete 5 chair rises will be measured before and after (3h, 24h, 48h, 72h) an acute bout of resistance exercise
Change in post exercise recovery of sEMG activity
Quadriceps muscle sEMG will be measured before and after (3h, 24h, 48h, 72h) an acute bout of resistance exercise
Change in post exercise interleukin-6
Circulating interleukin-6 will be measured before and after (3h, 24h, 48h, 72h) an acute bout of resistance exercise
Change in post exercise peroxiredoxin 3 redox state
Circulating peroxiredoxin 3 redox state will be measured before and after (3h, 24h, 48h, 72h) an acute bout of resistance exercise
Change in vitamin K levels
Vitamin K will be measured in baseline and 12 week samples
Change in Carboxylated Osteocalcin levels
Carboxylated Osteocalcin will be measured in baseline and 12 week samples
Change in uncarboxylated Osteocalcin levels
uncarboxylated Osteocalcin will be measured in baseline and 12 week samples
Change in carboxylated matrix gla-protein levels
carboxylated matrix gla-protein will be measured in baseline and 12 week samples
Change in dephosphorylated-uncarboxylated matrix gla-protein levels
dephosphorylated-uncarboxylated matrix gla-protein will be measured in baseline and 12 week samples
Change in post exercise F2 isoprostanes
Circulating F2 isoprostanes will be measured before and after (3h, 24h, 48h, 72h) an acute bout of resistance exercise

Full Information

First Posted
November 24, 2020
Last Updated
November 1, 2022
Sponsor
University of Glasgow
Collaborators
Kappa Bioscience
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1. Study Identification

Unique Protocol Identification Number
NCT04676958
Brief Title
viTAmin K2 and rEcOVery From ExeRcise
Acronym
TAKEOVER
Official Title
Effects of Vitamin K2 on Recovery From Muscle Damaging Exercise in Young and Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Glasgow
Collaborators
Kappa Bioscience

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation, Oxidative Stress, Vitamin K, Exercise, Strength, Recovery

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
380 mg capsule/day micro-crystalline cellulose
Arm Title
Vitamin K2
Arm Type
Active Comparator
Arm Description
380 mg capsule/day micro-crystalline cellulose including 240ug/day Vitamin K2
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin K2
Intervention Description
Vitamin K2
Intervention Type
Dietary Supplement
Intervention Name(s)
Micro-crystalline cellulose
Intervention Description
Micro-crystalline cellulose
Primary Outcome Measure Information:
Title
Change in post exercise recovery of muscle strength
Description
Muscle strength (MVC) of the knee extensor muscles will be measured before and after (3h, 24h, 48h, 72h) an acute bout of resistance exercise
Time Frame
Change from baseline to 12 weeks
Secondary Outcome Measure Information:
Title
Change in pain free range of motion during knee extension exercise
Description
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
Time Frame
Change from baseline to 12 weeks
Title
Change in post exercise recovery of functional abilities
Description
Time to complete 5 chair rises will be measured before and after (3h, 24h, 48h, 72h) an acute bout of resistance exercise
Time Frame
Change from baseline to 12 weeks
Title
Change in post exercise recovery of sEMG activity
Description
Quadriceps muscle sEMG will be measured before and after (3h, 24h, 48h, 72h) an acute bout of resistance exercise
Time Frame
Change from baseline to 12 weeks
Title
Change in post exercise interleukin-6
Description
Circulating interleukin-6 will be measured before and after (3h, 24h, 48h, 72h) an acute bout of resistance exercise
Time Frame
Change from baseline to 12 weeks
Title
Change in post exercise peroxiredoxin 3 redox state
Description
Circulating peroxiredoxin 3 redox state will be measured before and after (3h, 24h, 48h, 72h) an acute bout of resistance exercise
Time Frame
Change from baseline to 12 weeks
Title
Change in vitamin K levels
Description
Vitamin K will be measured in baseline and 12 week samples
Time Frame
Change from baseline to 12 weeks
Title
Change in Carboxylated Osteocalcin levels
Description
Carboxylated Osteocalcin will be measured in baseline and 12 week samples
Time Frame
Change from baseline to 12 weeks
Title
Change in uncarboxylated Osteocalcin levels
Description
uncarboxylated Osteocalcin will be measured in baseline and 12 week samples
Time Frame
Change from baseline to 12 weeks
Title
Change in carboxylated matrix gla-protein levels
Description
carboxylated matrix gla-protein will be measured in baseline and 12 week samples
Time Frame
Change from baseline to 12 weeks
Title
Change in dephosphorylated-uncarboxylated matrix gla-protein levels
Description
dephosphorylated-uncarboxylated matrix gla-protein will be measured in baseline and 12 week samples
Time Frame
Change from baseline to 12 weeks
Title
Change in post exercise F2 isoprostanes
Description
Circulating F2 isoprostanes will be measured before and after (3h, 24h, 48h, 72h) an acute bout of resistance exercise
Time Frame
Change from baseline to 12 weeks
Other Pre-specified Outcome Measures:
Title
Change in lean mass
Description
Change in lean mass
Time Frame
Change from baseline to 12 weeks
Title
Change in blood glucose
Description
Change in blood glucose
Time Frame
Change from baseline to 12 weeks
Title
Change in blood lipids
Description
Change in blood lipids
Time Frame
Change from baseline to 12 weeks
Title
Change in plasma insulin
Description
Change in plasma insulin
Time Frame
Change from baseline to 12 weeks
Title
Change in fat mass
Description
Change in fat mass
Time Frame
Change from baseline to 12 weeks
Title
Change in muscle thickness
Description
Change in muscle thickness
Time Frame
Change from baseline to 12 weeks
Title
Change in exercise substrate utilisation
Description
Energy expenditure, carbodhydrate and fat oxidation during treadmill walking
Time Frame
Change from baseline to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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).
Facility Information:
Facility Name
University of Glasgow
City
Glasgow
ZIP/Postal Code
G12 8TA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr H Lithgow, PhD
Phone
0141 330 2569
Email
hannah.lithgow@glasgow.ac.uk
Facility Name
Stuart Robert Gray
City
Glasgow
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stuart R Gray
Phone
01413302569
Email
stuart.gray@glasgow.ac.uk
Phone
01413302569
Ext
Gray
Email
stuart.gray@glasgow.ac.uk
First Name & Middle Initial & Last Name & Degree
Stuart R Gray, PhD

12. IPD Sharing Statement

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viTAmin K2 and rEcOVery From ExeRcise

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