Vitamin K-statusNCT01672099
Effects of Dairy on Vitamin K-status
A study testing nutrient enriched product and basic dairy product in people with Vitamin K-status and Vascular Health, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
In this study, the beneficial effect of a nutrient enriched dairy product will be investigated on vitamin K-status. To achive this benefit, the study product contains extra vitamin K2. In addition, extra dairy minerals have been added to the study product that may support general health. Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin K-status, Vascular Health
- What is being tested?
- nutrient enriched product and basic dairy product
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2010to Apr 2012
- 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 45 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Apparently healthy men and postmenopausal women between 45 and 65 years old
- Subjects of body weight and height according to BMI between 23 and 30 kg/m2
- Subjects of Caucasian race
- Subject has given written consent to take part in the study
- Low vitamin K-status
Who cannot join
- Subjects with hypertension
- Subjects with hypercholesterolemia
- Subjects with (a history of) metabolic or gastrointestinal disease
- Subjects presenting chronic degenerative and/or inflammatory disease
- Subjects with (a history) of diabetes mellitus
- Abuse of drugs and/or alcohol
Show all 13Show fewer
- Subjects receiving corticosteroϊd treatment
- Subjects using oral anticoagulants and subjects with clotting disorders
- Subjects using blood pressure lowering medication
- Subjects using cholesterol-lowering medication
- Subjects using multivitamins or vitamin K supplements
- Subjects consuming high amounts of vitamin K-containing food products
- Subjects with cow's milk allergy and lactose intolerance
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Vitak BV / Maastricht University Medical Center
Maastricht, 6229 EV
About this study
Official title: The Effects of a Vitamin K-enriched Dairy Product on Vitamin K-status
In this study, the beneficial effect of a nutrient enriched dairy product will be investigated on vitamin K-status. To achive this benefit, the study product contains extra vitamin K2. In addition, extra dairy minerals have been added to the study product that may support general health.
Read the detailed description
In earlier studies, cardiovascular disease and osteoporosis were found to be associated with K2 intake, notably the higher menaquinones, MK-7, MK-8 and MK-9. Of these higher menaquinones, MK-7 was suggested to be the most effective form with respect to intestinal absorption, biologic half-life time, and efficacy on circulating biochemical markers. MK-7 is a natural product that is found in cheese, curd, and the Japanese food natto. Therefore, a nutrient enriched dairy product has been developed containing MK-7. The efficacy of this new product will be investigated on vitamin K status and on general health markers.
- Conditions
- Vitamin K-status, Vascular Health
- Being tested
- nutrient enriched product, basic dairy product
- Keywords
- vitamin K2, menaquinone-7, vascular health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutrient enriched productDietary supplement
The intervention in this study consists of the consumption of two nutrient enriched yoghurt products. The participants consume the study products twice a day during 12 weeks, one yoghurt product (250 ml) during breakfast and one yoghurt product (250 ml) during dinner.
basic dairy productDietary supplement
The intervention in this study consists of the consumption of two basic yoghurt products. The participants consume the basic yoghurt products twice a day during 12 weeks, one yoghurt product (250 ml) during breakfast and one yoghurt product (250 ml) during dinner.
| Study group | Role | What they receive |
|---|---|---|
| nutrient enriched dairy | Active comparator | Yoghurt product which contains vitamin K2 and extra dairy nutrients; all in a concentration of 15% of the recommended allowed daily intake (RDI) Receives: Dietary Supplement: nutrient enriched product |
| Basic dairy | Placebo comparator | 2 basic yoghurt products Receives: Dietary Supplement: basic dairy product |
What is being measured
The primary outcome is the main question the study is designed to answer.
undercarboxylated and carboxylated matrix-gla protein
The purpose of this study is to investigate the nutrient enriched product on vitamin K status as determined from the carboxylation status of Matrix Gla Protein
Measured: 12 weeks
Secondary outcomes (1)
undercarboxylated and carboxylated osteocalcin
The second purpose of this study is to investigate the nutrient enriched product on vitamin K status as determined from the carboxylation status of the vitamin K-dependent protein osteocalcin
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2012 (estimated)
- Study startSep 2010
- Primary completionDec 2010
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin K-statusStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cees Vermeer, PhD, Principal investigator, VitaK BV Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01672099
- Sponsor's protocol ID
- 10-3-037
- Status last verified
- Aug 2012
- First submitted
- 9 Jul 2012
- Last updated
- 24 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Vitamin K-enriched Dairy Product on Vitamin K-status
- ClinicalTrials.gov ID
- NCT01672099
- Acronym / sponsor ID
- 10-3-037
- Conditions
- Vitamin K-status, Vascular Health
- Keywords
- vitamin K2, menaquinone-7, vascular health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 24 Aug 2012 (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.
In this study, the beneficial effect of a nutrient enriched dairy product will be investigated on vitamin K-status. To achive this benefit, the study product contains extra vitamin K2. In addition, extra dairy minerals have been added to the study product that may support general health.
Detailed description
In earlier studies, cardiovascular disease and osteoporosis were found to be associated with K2 intake, notably the higher menaquinones, MK-7, MK-8 and MK-9. Of these higher menaquinones, MK-7 was suggested to be the most effective form with respect to intestinal absorption, biologic half-life time, and efficacy on circulating biochemical markers. MK-7 is a natural product that is found in cheese, curd, and the Japanese food natto. Therefore, a nutrient enriched dairy product has been developed containing MK-7. The efficacy of this new product will be investigated on vitamin K status and on general health markers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nutrient enriched dairy | Active comparator | Dietary Supplement: nutrient enriched productYoghurt product which contains vitamin K2 and extra dairy nutrients; all in a concentration of 15% of the recommended allowed daily intake (RDI) |
| Basic dairy | Placebo comparator | Dietary Supplement: basic dairy product2 basic yoghurt products |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Apparently healthy men and postmenopausal women between 45 and 65 years old
- Subjects of body weight and height according to BMI between 23 and 30 kg/m2
- Subjects of Caucasian race
- Subject has given written consent to take part in the study
- Low vitamin K-status
Key exclusion criteria (13 listed)
- Subjects with hypertension
- Subjects with hypercholesterolemia
- Subjects with (a history of) metabolic or gastrointestinal disease
- Subjects presenting chronic degenerative and/or inflammatory disease
- Subjects with (a history) of diabetes mellitus
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 |
|---|---|---|
| nutrient enriched productThe intervention in this study consists of the consumption of two nutrient enriched yoghurt products. The participants consume the study products twice a day during 12 weeks, one yoghurt product (250 ml) during breakfast and one yoghurt product (250 ml) during dinner. | Dietary supplement | nutrient enriched dairy |
| basic dairy productThe intervention in this study consists of the consumption of two basic yoghurt products. The participants consume the basic yoghurt products twice a day during 12 weeks, one yoghurt product (250 ml) during breakfast and one yoghurt product (250 ml) during dinner. | Dietary supplement | Basic dairy |
Primary outcome
undercarboxylated and carboxylated matrix-gla protein
Time frame: 12 weeks
The purpose of this study is to investigate the nutrient enriched product on vitamin K status as determined from the carboxylation status of Matrix Gla Protein
1 secondary outcome
undercarboxylated and carboxylated osteocalcin
Time frame: 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 24 Aug 2012.
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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.
Cees Vermeer, PhD principal investigator
VitaK BV Maastricht 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 nutrient enriched product and basic dairy product in people with Vitamin K-status and Vascular Health, run by Maastricht University Medical Center at 1 site in Netherlands.
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 5 inclusion and 13 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 24 Aug 2012. 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 Netherlands. 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?
undercarboxylated and carboxylated matrix-gla protein (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Aug 2012.