Healthy IndividualsNCT01259570
Bioavailability of Vitamin D Encapsulated in Casein Micelles, Compared to Its Bioavailability in the Milk-fat, or in a Synthetic Emulsifier Currently Used for Supplementation and Enrichment
A study testing Group 1, Group 2 and group 3 in people with Healthy Individuals, run by Rambam Health Care Campus.
Trial summary
The encapsulation within CM may improve bioavailability (BA) of vitamin D (VD), even in absence of fat. As a model the investigators have chosen nonfat yoghurt. The investigators will prepare yoghurts from 4 milks: (1) Skimmilk enriched with 50,000 IU/150gr VD encapsulated in CM2 ; (2) 3% fat milk wherein same dose of… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Individuals
- What is being tested?
- Group 1, Group 2 and group 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to May 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers
Who cannot join
- Metabolic disorder
About this study
The encapsulation within CM may improve bioavailability (BA) of vitamin D (VD), even in absence of fat.
As a model the investigators have chosen nonfat yoghurt. The investigators will prepare yoghurts from 4 milks: (1) Skimmilk enriched with 50,000 IU/150gr VD encapsulated in CM2 ; (2) 3% fat milk wherein same dose of VD - dissolved in milk fat and homogenized into skimmilk; (3) 3% fat milk wherein VD, at same dose, will be in CM; (4) Placebo: unenriched skimmilk. 120 healthy adults aged 18-65 will randomized to 5 groups and receive 150 gr yoghurt. Blood will be drawn before ingestion and on days 1,7,14. 25(OH)D will be det. by CMIA. In vitro simulated digestion will be studied.
Expected results: The BA of VD in CM would not be lower than in fat
- Conditions
- Healthy Individuals
- Being tested
- Group 1, Group 2, group 3, Group 4
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1Dietary supplement
Skimmilk enriched with VD encapsulated in CM
Group 2Dietary supplement
VD will be dissolved in milkfat and homogenized into skimmilk
group 3Dietary supplement
3% fat milk wherein the VD will be in CM
Group 4Dietary supplement
Placebo: un-enriched skimmilk.
| Study group | Role | What they receive |
|---|---|---|
| Skimmilk enriched with VD encapsulated in CM | Active comparator | Not described Receives: Dietary Supplement: Group 1 |
| VD will be dissolved in milkfat and homogenized into skimmilk | Active comparator | VD will be dissolved in milkfat and homogenized into skimmilk Receives: Dietary Supplement: Group 2 |
| 3% fat milk wherein the VD will be in CM | Active comparator | 3% fat milk wherein the VD will be in CM Receives: Dietary Supplement: group 3 |
| Placebo: un-enriched skimmilk. | Active comparator | Placebo: un-enriched skimmilk. Receives: Dietary Supplement: Group 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioavailability of vitamin D encapsulated in casein micelles, compared to its bioavailability in the milk-fat.
As a model we have chosen nonfat yoghurt. We will prepare yoghurts from 4 milks: (1) Skimmilk enriched with 50,000 IU/150gr VD encapsulated in CM2 ; (2) 3% fat milk wherein same dose of VD - dissolved in milk fat and homogenized into skimmilk; (3) 3% fat milk wherein VD, at same dose, will be in CM; (4) Placebo: unenriched skimmilk. 120 healthy adults aged 18-65 will randomized to 5 groups and receive 150 gr yoghurt. Blood will be drawn before ingestion and on days 1,7,14. 25(OH)D will be det. by
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2010 (estimated)
- Study startJan 2011
- Primary completionDec 2011 (estimated)
- Study completionMay 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy IndividualsStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Collaborators
- Technion, Israel Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01259570
- Sponsor's protocol ID
- 3000007066
- Status last verified
- Dec 2010
- First submitted
- 12 Dec 2010
- Last updated
- 14 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability of Vitamin D Encapsulated in Casein Micelles, Compared to Its Bioavailability in the Milk-fat, or in a Synthetic Emulsifier Currently Used for Supplementation and Enrichment
- ClinicalTrials.gov ID
- NCT01259570
- Acronym / sponsor ID
- 3000007066
- Conditions
- Healthy Individuals
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Collaborators
- Technion, Israel Institute of Technology
- Study start
- Jan 2011
- Primary completion
- Dec 2011 (estimated)
- Study completion
- May 2012 (estimated)
- First posted
- 14 Dec 2010 (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.
The encapsulation within CM may improve bioavailability (BA) of vitamin D (VD), even in absence of fat.
As a model the investigators have chosen nonfat yoghurt. The investigators will prepare yoghurts from 4 milks: (1) Skimmilk enriched with 50,000 IU/150gr VD encapsulated in CM2 ; (2) 3% fat milk wherein same dose of VD - dissolved in milk fat and homogenized into skimmilk; (3) 3% fat milk wherein VD, at same dose, will be in CM; (4) Placebo: unenriched skimmilk. 120 healthy adults aged 18-65 will randomized to 5 groups and receive 150 gr yoghurt. Blood will be drawn before ingestion and on days 1,7,14. 25(OH)D will be det. by CMIA. In vitro simulated digestion will be studied.
Expected results: The BA of VD in CM would not be lower than in fat
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Skimmilk enriched with VD encapsulated in CM | Active comparator | Dietary Supplement: Group 1 |
| VD will be dissolved in milkfat and homogenized into skimmilk | Active comparator | Dietary Supplement: Group 2VD will be dissolved in milkfat and homogenized into skimmilk |
| 3% fat milk wherein the VD will be in CM | Active comparator | Dietary Supplement: group 33% fat milk wherein the VD will be in CM |
| Placebo: un-enriched skimmilk. | Active comparator | Dietary Supplement: Group 4Placebo: un-enriched skimmilk. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy volunteers
Key exclusion criteria (1 listed)
- Metabolic disorder
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 |
|---|---|---|
| Group 1Skimmilk enriched with VD encapsulated in CM | Dietary supplement | Skimmilk enriched with VD encapsulated in CM |
| Group 2VD will be dissolved in milkfat and homogenized into skimmilk | Dietary supplement | VD will be dissolved in milkfat and homogenized into skimmilk |
| group 33% fat milk wherein the VD will be in CM | Dietary supplement | 3% fat milk wherein the VD will be in CM |
| Group 4Placebo: un-enriched skimmilk. | Dietary supplement | Placebo: un-enriched skimmilk. |
Primary outcome
Bioavailability of vitamin D encapsulated in casein micelles, compared to its bioavailability in the milk-fat.
Time frame: 1 year
As a model we have chosen nonfat yoghurt. We will prepare yoghurts from 4 milks: (1) Skimmilk enriched with 50,000 IU/150gr VD encapsulated in CM2 ; (2) 3% fat milk wherein same dose of VD - dissolved in milk fat and homogenized into skimmilk; (3) 3% fat milk wherein VD, at same dose, will be in CM; (4) Placebo: unenriched skimmilk. 120 healthy adults aged 18-65 will randomized to 5 groups and receive 150 gr yoghurt. Blood will be drawn before ingestion and on days 1,7,14. 25(OH)D will be det. by
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Group 1, Group 2 and group 3 in people with Healthy Individuals, run by Rambam Health Care Campus.
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 1 inclusion and 1 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 14 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Bioavailability of vitamin D encapsulated in casein micelles, compared to its bioavailability in the milk-fat. (time frame: 1 year). 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 14 Dec 2010.