NCT04676958

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2020

Completed
27 days until next milestone

First Posted

Study publicly available on registry

December 21, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

November 28, 2023

Status Verified

November 1, 2023

Enrollment Period

2.2 years

First QC Date

November 24, 2020

Last Update Submit

November 26, 2023

Conditions

InflammationOxidative StressVitamin KExerciseStrengthRecovery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Change in pain free range of motion during knee extension exercise

    Change from baseline to 12 weeks

  • Change in post exercise recovery of functional abilities

    Change from baseline to 12 weeks

  • Change in post exercise recovery of sEMG activity

    Change from baseline to 12 weeks

  • Change in post exercise interleukin-6

    Change from baseline to 12 weeks

  • Change in post exercise peroxiredoxin 3 redox state

    Change from baseline to 12 weeks

  • +6 more secondary outcomes

Other Outcomes (7)

  • Change in lean mass

    Change from baseline to 12 weeks

  • Change in blood glucose

    Change from baseline to 12 weeks

  • Change in blood lipids

    Change from baseline to 12 weeks

  • +4 more other outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

380 mg capsule/day micro-crystalline cellulose

Dietary Supplement: Micro-crystalline cellulose

Vitamin K2

ACTIVE COMPARATOR

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

Dietary Supplement: Vitamin K2

Interventions

Vitamin K2DIETARY_SUPPLEMENT

Vitamin K2

Vitamin K2
Micro-crystalline celluloseDIETARY_SUPPLEMENT

Micro-crystalline cellulose

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Glasgow

Glasgow, G12 8TA, United Kingdom

Location

Stuart Robert Gray

Glasgow, United Kingdom

Location

Related Publications (1)

  • Lithgow H, Johnston L, Ho FK, Celis-Morales C, Cobley J, Raastad T, Hunter AM, Lees JS, Mark PB, Quinn TJ, Gray SR. Protocol for a randomised controlled trial to investigate the effects of vitamin K2 on recovery from muscle-damaging resistance exercise in young and older adults-the TAKEOVER study. Trials. 2022 Dec 20;23(1):1026. doi: 10.1186/s13063-022-06937-y.

    PMID: 36539791DERIVED

MeSH Terms

Conditions

InflammationMotor Activity

Interventions

Vitamin K 2

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Vitamin KNaphthoquinonesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPhytolDiterpenesTerpenesQuinonesPolycyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer

Study Record Dates

First Submitted

November 24, 2020

First Posted

December 21, 2020

Study Start

April 1, 2021

Primary Completion

July 1, 2023

Study Completion

July 1, 2023

Last Updated

November 28, 2023

Record last verified: 2023-11

Locations

GB(2)