TAKEOVER: viTAmin K2 and rEcOVery From ExeRcise

• Sponsor: University of Glasgow (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04676958
• Collaborator: Kappa Bioscience (Other)
• Enrollment: 80
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 18
• Patients Per Site: 40
• Patients Per Site Per Month: 2.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Inflammation; Oxidative Stress; Vitamin K; Exercise; Strength; Recovery	Dietary Supplement: Vitamin K2; Dietary Supplement: Micro-crystalline cellulose	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Effects of Vitamin K2 on Recovery From Muscle Damaging Exercise in Young and Older Adults
• Actual Study Start Date: Apr 1, 2021
• Anticipated Primary Completion Date: Oct 1, 2022
• Anticipated Study Completion Date: Oct 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in post exercise recovery of muscle strength [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 Outcome Measures

1. Change in pain free range of motion during knee extension exercise [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 [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 [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 [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 [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 [Change from baseline to 12 weeks]

   Vitamin K will be measured in baseline and 12 week samples

7. Change in Carboxylated Osteocalcin levels [Change from baseline to 12 weeks]

   Carboxylated Osteocalcin will be measured in baseline and 12 week samples

8. Change in uncarboxylated Osteocalcin levels [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 [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 [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 [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 Outcome Measures

1. Change in lean mass [Change from baseline to 12 weeks]

   Change in lean mass

2. Change in blood glucose [Change from baseline to 12 weeks]

   Change in blood glucose

3. Change in blood lipids [Change from baseline to 12 weeks]

   Change in blood lipids

4. Change in plasma insulin [Change from baseline to 12 weeks]

   Change in plasma insulin

5. Change in fat mass [Change from baseline to 12 weeks]

   Change in fat mass

6. Change in muscle thickness [Change from baseline to 12 weeks]

   Change in muscle thickness

7. Change in exercise substrate utilisation [Change from baseline to 12 weeks]

   Energy expenditure, carbodhydrate and fat oxidation during treadmill walking

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Glasgow	Glasgow		United Kingdom	G12 8TA
2	Stuart Robert Gray	Glasgow		United Kingdom

Sponsors and Collaborators

• University of Glasgow
• Kappa Bioscience

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stuart Gray, Senior Lecturer, University of Glasgow
• ClinicalTrials.gov Identifier: NCT04676958
• Other Study ID Numbers: 200190189
• First Posted: Dec 21, 2020
• Last Update Posted: May 25, 2021
• Last Verified: May 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Inflammation; Vitamin K; Vitamin K 2

Study Results

No Results Posted as of May 25, 2021