InflammationTAKEOVERNCT04676958
viTAmin K2 and rEcOVery From ExeRcise
A study testing Vitamin K2 and Micro-crystalline cellulose in people with Inflammation and Oxidative Stress, run by University of Glasgow at 2 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inflammation, Oxidative Stress, Vitamin K
- What is being tested?
- Vitamin K2 and Micro-crystalline cellulose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Apr 2021to 1 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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).
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
University of Glasgow
Glasgow, G12 8TA
Stuart Robert Gray
Glasgow
About this study
Official title: 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.
- Conditions
- Inflammation, Oxidative Stress, Vitamin K, Exercise, Strength, Recovery
- Being tested
- Vitamin K2, Micro-crystalline cellulose
- Medical subject headings
- Inflammation, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin K2Dietary supplement
Vitamin K2
Micro-crystalline celluloseDietary supplement
Micro-crystalline cellulose
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 380 mg capsule/day micro-crystalline cellulose Receives: Dietary Supplement: Micro-crystalline cellulose |
| Vitamin K2 | Active comparator | 380 mg capsule/day micro-crystalline cellulose including 240ug/day Vitamin K2 Receives: Dietary Supplement: Vitamin K2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from baseline to 12 weeks
Secondary outcomes (11)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Change from baseline to 12 weeks
Change in vitamin K levels
Vitamin K will be measured in baseline and 12 week samples
Measured: Change from baseline to 12 weeks
Change in Carboxylated Osteocalcin levels
Carboxylated Osteocalcin will be measured in baseline and 12 week samples
Measured: Change from baseline to 12 weeks
Change in uncarboxylated Osteocalcin levels
uncarboxylated Osteocalcin will be measured in baseline and 12 week samples
Measured: 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
Measured: 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
Measured: 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
Measured: Change from baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start1 Apr 2021
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Collaborators
- Kappa Bioscience
- Responsible party
- Principal investigator, Stuart Gray, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04676958
- Sponsor's protocol ID
- 200190189
- Acronym
- TAKEOVER
- Status last verified
- Nov 2023
- First submitted
- 24 Nov 2020
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36539791
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vitamin K2 on Recovery From Muscle Damaging Exercise in Young and Older Adults
- ClinicalTrials.gov ID
- NCT04676958
- Acronym / sponsor ID
- TAKEOVER / 200190189
- Conditions
- Inflammation, Oxidative Stress, Vitamin K, Exercise, Strength, Recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Collaborators
- Kappa Bioscience
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 21 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Micro-crystalline cellulose380 mg capsule/day micro-crystalline cellulose |
| Vitamin K2 | Active comparator | Dietary Supplement: Vitamin K2380 mg capsule/day micro-crystalline cellulose including 240ug/day Vitamin K2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin K2Vitamin K2 | Dietary supplement | Vitamin K2 |
| Micro-crystalline celluloseMicro-crystalline cellulose | Dietary supplement | Placebo |
Primary outcome
Change in post exercise recovery of muscle strength
Time frame: 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
11 secondary outcomes
Change in pain free range of motion during knee extension exercise
Time frame: Change from baseline to 12 weeks
Change in post exercise recovery of functional abilities
Time frame: Change from baseline to 12 weeks
Change in post exercise recovery of sEMG activity
Time frame: Change from baseline to 12 weeks
Change in post exercise interleukin-6
Time frame: Change from baseline to 12 weeks
Change in post exercise peroxiredoxin 3 redox state
Time frame: Change from baseline to 12 weeks
Change in vitamin K levels
Time frame: Change from baseline to 12 weeks
Change in Carboxylated Osteocalcin levels
Time frame: Change from baseline to 12 weeks
Change in uncarboxylated Osteocalcin levels
Time frame: Change from baseline to 12 weeks
Change in carboxylated matrix gla-protein levels
Time frame: Change from baseline to 12 weeks
Change in dephosphorylated-uncarboxylated matrix gla-protein levels
Time frame: Change from baseline to 12 weeks
Change in post exercise F2 isoprostanes
Time frame: Change from baseline to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Derived from this study: PubMed 36539791Lithgow 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.
Related trials for Inflammation
Not yet recruitingPhase 2
A Phase 2 Study to Compare Efficacy and Safety of a Novel Topical Therapy (APT-001, Spinosad 1.8%) in Patients With Blepharitis
Blepharitis
Not yet recruitingObservational study
Arterial Stiffness During Negative Pressure Wound Therapy for Abdominal Wall Wounds
Postoperative Abdominal Wall Wound Complications, Surgical Wound Infection
RecruitingObservational study
Effects Of Periodontal Therapy In Patients With Inflammatory Bowel Disease
Periodontal Diseases, IBD
Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Active, not recruitingPhase 2
A Study to Evaluate Efficacy, Safety and Tolerability of Hydroxychloroquine in Subjects With Parkinson's Disease
Parkinson&Amp;#39;s Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin K2 and Micro-crystalline cellulose in people with Inflammation and Oxidative Stress, run by University of Glasgow at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in post exercise recovery of muscle strength (time frame: Change from baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04676958, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.