ObesityNCT02366481
Vitamin K and Glucose Metabolism in Adults at Risk for Diabetes (Vita-K 'n' Adults Study)
A study testing Low-Dose Vitamin K2 Supplement (menaquinone-7; 90-mcg/d) and High-Dose Vitamin K2 Supplement (menaquinone-7; 180-mcg/d) in people with Obesity and Insulin Resistance, run by Augusta University at 1 site in United States.
Trial summary
Given that glutamate carboxylation or decarboxylation is key to the metabolic role of osteocalcin (at least in mouse models) and that carboxylation is vitamin K dependent, it is critical to isolate the effect of vitamin K manipulation on carboxylation of osteocalcin and its subsequent effect on glucose metabolism in… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Insulin Resistance, Insulin Sensitivity
- What is being tested?
- Low-Dose Vitamin K2 Supplement (menaquinone-7; 90-mcg/d) and High-Dose Vitamin K2 Supplement (menaquinone-7; 180-mcg/d)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to 30 Jun 2020
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults between 18 and 65 years old
- Subject understands the study protocol and agrees to comply with it
- Informed Consent Form signed by the subject
Who cannot join
- Subjects using vitamin supplements containing vitamin k
- Subjects with (a history of) metabolic or gastrointestinal diseases including hepatic disorders
- Subjects presenting chronic degenerative and/or inflammatory diseases
- Subjects receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters (salicylates, antibiotics)
- Subjects receiving corticosteroid treatment
- Subjects using oral anticoagulants
- Subjects with a history of soy allergy
- Subjects who have participated in a clinical study more recently than one month before the current study
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Georgia; Augusta University
Augusta, Georgia, 30912
About this study
Official title: Vitamin K and Glucose Metabolism in Adults at Risk for Diabetes
Given that glutamate carboxylation or decarboxylation is key to the metabolic role of osteocalcin (at least in mouse models) and that carboxylation is vitamin K dependent, it is critical to isolate the effect of vitamin K manipulation on carboxylation of osteocalcin and its subsequent effect on glucose metabolism in clinical trials. The purpose of this randomized, double-blind, placebo-controlled clinical trial in adults is to determine whether eight weeks of daily supplementation with vitamin K2 (menaquinone-7) can improve markers in blood associated with diabetes risk.
- Being tested
- Placebo, Low-Dose Vitamin K2 Supplement (menaquinone-7; 90-mcg/d), High-Dose Vitamin K2 Supplement (menaquinone-7; 180-mcg/d)
- Keywords
- Vitamin K, Vitamin K2, Menaquinone-7, Osteocalcin, Adults, Obesity, Insulin resistance, Insulin sensitivity, Beta-cell function, Prediabetes
- Medical subject headings
- Obesity, Insulin Resistance, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Two placebo softgel capsules (containing no vitamin K2) every day for 8 weeks.
Low-Dose Vitamin K2 Supplement (menaquinone-7; 90-mcg/d)Dietary supplement
One 90-mcg vitamin K2 softgel capsules (containing no vitamin K2) and one placebo softgel capsule everyday for 8 weeks.
High-Dose Vitamin K2 Supplement (menaquinone-7; 180-mcg/d)Dietary supplement
Two 90-mcg vitamin K2 softgel capsules every day for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo-Control | Placebo comparator | The placebo-control group will take two placebo softgel capsules every day for 8 weeks. Receives: Dietary Supplement: Placebo |
| Low-Dose Vitamin K2 (90-mcg/d) | Active comparator | The low-dose vitamin K group will take one 90-mcg vitamin K2 (menaquinone-7) softgel capsule and one placebo softgel capsule every day for 8 weeks. Receives: Dietary Supplement: Low-Dose Vitamin K2 Supplement (menaquinone-7; 90-mcg/d) |
| High-Dose Vitamin K2 (180-mcg/d) | Active comparator | The high-dose vitamin K group will take two 90-mcg vitamin K2 (menaquinone-7) softgel capsules every day for 8 weeks. Receives: Dietary Supplement: High-Dose Vitamin K2 Supplement (menaquinone-7; 180-mcg/d) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in insulin sensitivity
Insulin sensitivity will be calculated from plasma insulin and glucose concentrations measured during a 2-hour oral glucose tolerance test by using the oral glucose minimal model.
Measured: Change from baseline in insulin sensitivity at 8 weeks
Change in beta-cell function
Beta-cell function, as assessed by dynamic beta-cell responsitivity, will be calculated from plasma glucose and C-peptide concentrations measured during a 2-hour oral glucose tolerance test by using the oral C-peptide minimal model.
Measured: Change from baseline in beta-cell function at 8 weeks
Secondary outcomes (4)
Change in prothrombin time (PT)
Measured: Change from baseline in PT at 8 weeks
Change in activated partial thromboplastin time (aPTT)
Measured: Change from baseline in aPTT at 8 weeks
Change in arterial stiffness (PWV)
Arterial stiffness will be assessed using carotid-femoral pulse wave velocity (PWV) by applanation tonometry.
Measured: Change from baseline in arterial stiffness at 8 weeks
Change in endothelial function (FMD)
Endothelial function will be assessed using brachial artery flow-mediated dilation (FMD) by ultrasound.
Measured: Change from baseline in endothelial function at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completion1 Jun 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alabama at Birmingham, Yale University, Tufts University
- Responsible party
- Principal investigator, Norman Pollock, Augusta University
- Investigators
- Norman K Pollock, Ph.D., Principal investigator, Department of Pediatrics, Medical College of Georgia, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02366481
- Sponsor's protocol ID
- 620511
- Other IDs
- 16GRNT31090037
- Status last verified
- Nov 2019
- First submitted
- 12 Feb 2015
- Last updated
- 20 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pollock NK, Bernard PJ, Gower BA, Gundberg CM, Wenger K, Misra S, Bassali RW, Davis CL. Lower uncarboxylated osteocalcin concentrations in children with prediabetes is associated with beta-cell function. J Clin Endocrinol Metab. 2011 Jul;96(7):E1092-9. doi: 10.1210/jc.2010-2731. Epub 2011 Apr 20.
PubMed 21508147Gower BA, Pollock NK, Casazza K, Clemens TL, Goree LL, Granger WM. Associations of total and undercarboxylated osteocalcin with peripheral and hepatic insulin sensitivity and beta-cell function in overweight adults. J Clin Endocrinol Metab. 2013 Jul;98(7):E1173-80. doi: 10.1210/jc.2013-1203. Epub 2013 Apr 24.
PubMed 23616149Booth SL, Centi A, Smith SR, Gundberg C. The role of osteocalcin in human glucose metabolism: marker or mediator? Nat Rev Endocrinol. 2013 Jan;9(1):43-55. doi: 10.1038/nrendo.2012.201. Epub 2012 Nov 13.
PubMed 23147574Pollock NK. Childhood obesity, bone development, and cardiometabolic risk factors. Mol Cell Endocrinol. 2015 Jul 15;410:52-63. doi: 10.1016/j.mce.2015.03.016. Epub 2015 Mar 27.
PubMed 25817542
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin K and Glucose Metabolism in Adults at Risk for Diabetes
- ClinicalTrials.gov ID
- NCT02366481
- Acronym / sponsor ID
- 620511
- Keywords
- Vitamin K, Vitamin K2, Menaquinone-7, Osteocalcin, Adults, Obesity, Insulin resistance, Insulin sensitivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Collaborators
- University of Alabama at Birmingham, Yale University, Tufts University
- Study start
- Feb 2015
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 19 Feb 2015 (estimated)
- 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.
Given that glutamate carboxylation or decarboxylation is key to the metabolic role of osteocalcin (at least in mouse models) and that carboxylation is vitamin K dependent, it is critical to isolate the effect of vitamin K manipulation on carboxylation of osteocalcin and its subsequent effect on glucose metabolism in clinical trials. The purpose of this randomized, double-blind, placebo-controlled clinical trial in adults is to determine whether eight weeks of daily supplementation with vitamin K2 (menaquinone-7) can improve markers in blood associated with diabetes risk.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo-Control | Placebo comparator | Dietary Supplement: PlaceboThe placebo-control group will take two placebo softgel capsules every day for 8 weeks. |
| Low-Dose Vitamin K2 (90-mcg/d) | Active comparator | Dietary Supplement: Low-Dose Vitamin K2 Supplement (menaquinone-7; 90-mcg/d)The low-dose vitamin K group will take one 90-mcg vitamin K2 (menaquinone-7) softgel capsule and one placebo softgel capsule every day for 8 weeks. |
| High-Dose Vitamin K2 (180-mcg/d) | Active comparator | Dietary Supplement: High-Dose Vitamin K2 Supplement (menaquinone-7; 180-mcg/d)The high-dose vitamin K group will take two 90-mcg vitamin K2 (menaquinone-7) softgel capsules every day for 8 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy adults between 18 and 65 years old
- Subject understands the study protocol and agrees to comply with it
- Informed Consent Form signed by the subject
Key exclusion criteria (8 listed)
- Subjects using vitamin supplements containing vitamin k
- Subjects with (a history of) metabolic or gastrointestinal diseases including hepatic disorders
- Subjects presenting chronic degenerative and/or inflammatory diseases
- Subjects receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters (salicylates, antibiotics)
- Subjects receiving corticosteroid treatment
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 |
|---|---|---|
| PlaceboTwo placebo softgel capsules (containing no vitamin K2) every day for 8 weeks. | Dietary supplement | Placebo-Control |
| Low-Dose Vitamin K2 Supplement (menaquinone-7; 90-mcg/d)One 90-mcg vitamin K2 softgel capsules (containing no vitamin K2) and one placebo softgel capsule everyday for 8 weeks. | Dietary supplement | Low-Dose Vitamin K2 (90-mcg/d) |
| High-Dose Vitamin K2 Supplement (menaquinone-7; 180-mcg/d)Two 90-mcg vitamin K2 softgel capsules every day for 8 weeks. | Dietary supplement | High-Dose Vitamin K2 (180-mcg/d) |
Primary outcome
Change in insulin sensitivity
Time frame: Change from baseline in insulin sensitivity at 8 weeks
Insulin sensitivity will be calculated from plasma insulin and glucose concentrations measured during a 2-hour oral glucose tolerance test by using the oral glucose minimal model.
Change in beta-cell function
Time frame: Change from baseline in beta-cell function at 8 weeks
Beta-cell function, as assessed by dynamic beta-cell responsitivity, will be calculated from plasma glucose and C-peptide concentrations measured during a 2-hour oral glucose tolerance test by using the oral C-peptide minimal model.
4 secondary outcomes
Change in prothrombin time (PT)
Time frame: Change from baseline in PT at 8 weeks
Change in activated partial thromboplastin time (aPTT)
Time frame: Change from baseline in aPTT at 8 weeks
Change in arterial stiffness (PWV)
Time frame: Change from baseline in arterial stiffness at 8 weeks
Change in endothelial function (FMD)
Time frame: Change from baseline in endothelial function at 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2019.
- Background: PubMed 21508147Pollock NK, Bernard PJ, Gower BA, Gundberg CM, Wenger K, Misra S, Bassali RW, Davis CL. Lower uncarboxylated osteocalcin concentrations in children with prediabetes is associated with beta-cell function. J Clin Endocrinol Metab. 2011 Jul;96(7):E1092-9. doi: 10.1210/jc.2010-2731. Epub 2011 Apr 20.
- Background: PubMed 23616149Gower BA, Pollock NK, Casazza K, Clemens TL, Goree LL, Granger WM. Associations of total and undercarboxylated osteocalcin with peripheral and hepatic insulin sensitivity and beta-cell function in overweight adults. J Clin Endocrinol Metab. 2013 Jul;98(7):E1173-80. doi: 10.1210/jc.2013-1203. Epub 2013 Apr 24.
- Background: PubMed 23147574Booth SL, Centi A, Smith SR, Gundberg C. The role of osteocalcin in human glucose metabolism: marker or mediator? Nat Rev Endocrinol. 2013 Jan;9(1):43-55. doi: 10.1038/nrendo.2012.201. Epub 2012 Nov 13.
- Background: PubMed 25817542Pollock NK. Childhood obesity, bone development, and cardiometabolic risk factors. Mol Cell Endocrinol. 2015 Jul 15;410:52-63. doi: 10.1016/j.mce.2015.03.016. Epub 2015 Mar 27.
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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.
Norman K Pollock, Ph.D. principal investigator
Department of Pediatrics, Medical College of Georgia, Augusta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Dose Vitamin K2 Supplement (menaquinone-7; 90-mcg/d) and High-Dose Vitamin K2 Supplement (menaquinone-7; 180-mcg/d) in people with Obesity and Insulin Resistance, run by Augusta University at 1 site in United States.
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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 20 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Results are not available in the source record.
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 insulin sensitivity (time frame: Change from baseline in insulin sensitivity at 8 weeks). The study lists 2 primary outcomes in all. 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 NCT02366481, which also lists 4 linked publications.
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 20 Nov 2019.