viTAmin K2 and rEcOVery From ExeRcise (TAKEOVER)

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: Inflammation; Exercise; Recovery; Oxidative Stress; Strength; Vitamin K
• Intervention / Treatment: Dietary supplement: Micro-crystalline cellulose; Dietary supplement: Vitamin K2

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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 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	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	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	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	Vitamin K will be measured in baseline and 12 week samples	Change from baseline to 12 weeks
Change in Carboxylated Osteocalcin levels	Carboxylated Osteocalcin will be measured in baseline and 12 week samples	Change from baseline to 12 weeks
Change in uncarboxylated Osteocalcin levels	uncarboxylated Osteocalcin will be measured in baseline and 12 week samples	Change from baseline to 12 weeks
Change in carboxylated matrix gla-protein levels	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	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	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	Change in lean mass	Change from baseline to 12 weeks
Change in blood glucose	Change in blood glucose	Change from baseline to 12 weeks
Change in blood lipids	Change in blood lipids	Change from baseline to 12 weeks
Change in plasma insulin	Change in plasma insulin	Change from baseline to 12 weeks
Change in fat mass	Change in fat mass	Change from baseline to 12 weeks
Change in muscle thickness	Change in muscle thickness	Change from baseline to 12 weeks
Change in exercise substrate utilisation	Energy expenditure, carbodhydrate and fat oxidation during treadmill walking	Change from baseline to 12 weeks

Collaborators and Investigators

• Sponsor: University of Glasgow
• Collaborators: Kappa Bioscience

Study record dates

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: Pathologic Processes; Inflammation; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Micronutrients; Vitamins; Antifibrinolytic Agents; Hemostatics; Coagulants; Vitamin K; Vitamin K 2
• 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