Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
80 participants
INTERVENTIONAL
2021-04-01
2023-07-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo
380 mg capsule/day micro-crystalline cellulose
Micro-crystalline cellulose
Micro-crystalline cellulose
Vitamin K2
380 mg capsule/day micro-crystalline cellulose including 240ug/day Vitamin K2
Vitamin K2
Vitamin K2
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Vitamin K2
Vitamin K2
Micro-crystalline cellulose
Micro-crystalline cellulose
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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).
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Kappa Bioscience
UNKNOWN
University of Glasgow
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Stuart Gray
Senior Lecturer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Glasgow
Glasgow, , United Kingdom
Stuart Robert Gray
Glasgow, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
200190189
Identifier Type: -
Identifier Source: org_study_id