BioavailabilityNCT00858767
Arabic Gum-Absorption Study
A study testing menaquinone-7 from casein capsules, menaquinone-7 from arabic gum capsules and menaquinone-7 from linseed oil capsules in people with Bioavailability, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Previous studies have indicated that menaquinone-7 (MK-7) is the most effective form of vitamin K. The Japanese soya product natto is one of the richest food sources of MK-7, but its taste is not appreciated by the Western society. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioavailability
- What is being tested?
- menaquinone-7 from casein capsules, menaquinone-7 from arabic gum capsules and menaquinone-7 from linseed oil capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2008to Aug 2009
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women aged between 20 and 40 y
- Normal body weight and height (BMI <30 kg/m2)
- Stable body weight (weight gain or loss <3 kg in past 3 mo)
- Caucasian race
- Written consent to take part in the study
- Low vitamin K status
Who cannot join
- (A history of) metabolic or gastrointestinal diseases
- Chronic degenerative and/or inflammatory diseases
- Abuse of drugs and/or alcohol
- Use of corticosteroids
- Use of oral anticoagulants
- (A history of) soy allergy
Show all 9Show fewer
- Use of vitamin K-containing multivitamins or vitamin K supplements
- Anaemia
- Blood donation or participation in another study within one month before the study
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
VitaK BV /University of Maastricht
Maastricht, PO Box 616
About this study
Official title: Comparison of Absorption and Efficacy of 3 Different Menaquinone-7 Delivery Systems; Casein Powder, Arabic Gum Powder, or Linseed Oil
Previous studies have indicated that menaquinone-7 (MK-7) is the most effective form of vitamin K. The Japanese soya product natto is one of the richest food sources of MK-7, but its taste is not appreciated by the Western society. For this reason, the active biological compound has been manufactured as enriched oil or casein (≈80% of proteins in cow's milk)-enriched powder. However, cow's milk allergy is the most common cause of food allergy affecting a minimum of 2-3% of infants. The investigators will therefore compare this protein-delivery system to an alternative delivery system (Arabic gum; 98% polysaccharides). To compare the difference between powder and oil as MK-7 delivery vehicle, the investigators will also test the efficacy of enriched linseed oil.
- Conditions
- Bioavailability
- Being tested
- menaquinone-7 from casein capsules, menaquinone-7 from arabic gum capsules, menaquinone-7 from linseed oil capsules
- Keywords
- vitamin K2, absorption, efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
menaquinone-7 from casein capsulesDietary supplement
90 µg menaquinone-7 daily during 8 weeks
menaquinone-7 from arabic gum capsulesDietary supplement
90 µg menaquinone-7 daily during 8 weeks
menaquinone-7 from linseed oil capsulesDietary supplement
90 µg menaquinone-7 daily during 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 2 casein capsules per day existing of 90 µg menaquinone-7 per day for 8 weeks Receives: Dietary Supplement: menaquinone-7 from casein capsules |
| 2 | Active comparator | 2 arabic gum capsules per day existing of 90 µg menaquinone-7 per day for 8 weeks Receives: Dietary Supplement: menaquinone-7 from arabic gum capsules |
| 3 | Active comparator | 2 linseed capsules existing of 90 µg menaquinone-7 per day for 8 weeks Receives: Dietary Supplement: menaquinone-7 from linseed oil capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum level menaquinone-7
Measured: 8 weeks
Secondary outcomes (1)
plasma level of biochemical markers carboxylated matrix-Gla protein, undercarboxylated matrix-Gla protein, carboxylated osteocalcin, undercarboxylated osteocalcin
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2009 (estimated)
- Study startOct 2008
- Primary completionMay 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioavailabilityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Cees Vermeer, PhD, Principal investigator, VitaK /University of Maastricht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00858767
- Sponsor's protocol ID
- 08-3-064
- Status last verified
- Dec 2010
- First submitted
- 9 Mar 2009
- Last updated
- 16 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Absorption and Efficacy of 3 Different Menaquinone-7 Delivery Systems; Casein Powder, Arabic Gum Powder, or Linseed Oil
- ClinicalTrials.gov ID
- NCT00858767
- Acronym / sponsor ID
- 08-3-064
- Conditions
- Bioavailability
- Keywords
- vitamin K2, absorption, efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- May 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 10 Mar 2009 (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.
Previous studies have indicated that menaquinone-7 (MK-7) is the most effective form of vitamin K. The Japanese soya product natto is one of the richest food sources of MK-7, but its taste is not appreciated by the Western society. For this reason, the active biological compound has been manufactured as enriched oil or casein (≈80% of proteins in cow's milk)-enriched powder. However, cow's milk allergy is the most common cause of food allergy affecting a minimum of 2-3% of infants. The investigators will therefore compare this protein-delivery system to an alternative delivery system (Arabic gum; 98% polysaccharides). To compare the difference between powder and oil as MK-7 delivery vehicle, the investigators will also test the efficacy of enriched linseed oil.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Dietary Supplement: menaquinone-7 from casein capsules2 casein capsules per day existing of 90 µg menaquinone-7 per day for 8 weeks |
| 2 | Active comparator | Dietary Supplement: menaquinone-7 from arabic gum capsules2 arabic gum capsules per day existing of 90 µg menaquinone-7 per day for 8 weeks |
| 3 | Active comparator | Dietary Supplement: menaquinone-7 from linseed oil capsules2 linseed capsules existing of 90 µg menaquinone-7 per day for 8 weeks |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy men and women aged between 20 and 40 y
- Normal body weight and height (BMI <30 kg/m2)
- Stable body weight (weight gain or loss <3 kg in past 3 mo)
- Caucasian race
- Written consent to take part in the study
Key exclusion criteria (9 listed)
- (A history of) metabolic or gastrointestinal diseases
- Chronic degenerative and/or inflammatory diseases
- Abuse of drugs and/or alcohol
- Use of corticosteroids
- Use of oral anticoagulants
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 |
|---|---|---|
| menaquinone-7 from casein capsules90 µg menaquinone-7 daily during 8 weeks | Dietary supplement | 1 |
| menaquinone-7 from arabic gum capsules90 µg menaquinone-7 daily during 8 weeks | Dietary supplement | 2 |
| menaquinone-7 from linseed oil capsules90 µg menaquinone-7 daily during 8 weeks | Dietary supplement | 3 |
Primary outcome
serum level menaquinone-7
Time frame: 8 weeks
1 secondary outcome
plasma level of biochemical markers carboxylated matrix-Gla protein, undercarboxylated matrix-Gla protein, carboxylated osteocalcin, undercarboxylated osteocalcin
Time frame: 8 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 16 Dec 2010.
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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 /University of Maastricht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing menaquinone-7 from casein capsules, menaquinone-7 from arabic gum capsules and menaquinone-7 from linseed oil capsules in people with Bioavailability, 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 6 inclusion and 9 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 16 Dec 2010. 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. 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?
serum level menaquinone-7 (time frame: 8 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 16 Dec 2010.