viTAmin K2 and rEcOVery From ExeRcise

Inflammation Clinical Trial

— TAKEOVER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04676958
• Other study ID #: 200190189
• Status: Completed
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: July 1, 2023

Study information

• Verified date: November 2023
• Source: University of Glasgow
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Exercise
• Inflammation
• Oxidative Stress
• Recovery
• Strength
• Vitamin K

Intervention

Dietary Supplement:
• Vitamin K2
Vitamin K2
• Micro-crystalline cellulose
Micro-crystalline cellulose

Locations

Country	Name	City	State
United Kingdom	Stuart Robert Gray	Glasgow
United Kingdom	University of Glasgow	Glasgow

Sponsors (2)

Lead Sponsor	Collaborator
University of Glasgow	Kappa Bioscience

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in lean mass	Change in lean mass	Change from baseline to 12 weeks
Other	Change in blood glucose	Change in blood glucose	Change from baseline to 12 weeks
Other	Change in blood lipids	Change in blood lipids	Change from baseline to 12 weeks
Other	Change in plasma insulin	Change in plasma insulin	Change from baseline to 12 weeks
Other	Change in fat mass	Change in fat mass	Change from baseline to 12 weeks
Other	Change in muscle thickness	Change in muscle thickness	Change from baseline to 12 weeks
Other	Change in exercise substrate utilisation	Energy expenditure, carbodhydrate and fat oxidation during treadmill walking	Change from baseline to 12 weeks
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in vitamin K levels	Vitamin K will be measured in baseline and 12 week samples	Change from baseline to 12 weeks
Secondary	Change in Carboxylated Osteocalcin levels	Carboxylated Osteocalcin will be measured in baseline and 12 week samples	Change from baseline to 12 weeks
Secondary	Change in uncarboxylated Osteocalcin levels	uncarboxylated Osteocalcin will be measured in baseline and 12 week samples	Change from baseline to 12 weeks
Secondary	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
Secondary	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
Secondary	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