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
NCT ID: NCT01259570
Last Updated: 2010-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2011-01-31
2012-05-31
Brief Summary
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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
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Skimmilk enriched with VD encapsulated in CM
Group 1
Skimmilk enriched with VD encapsulated in CM
VD will be dissolved in milkfat and homogenized into skimmilk
VD will be dissolved in milkfat and homogenized into skimmilk
Group 2
VD will be dissolved in milkfat and homogenized into skimmilk
3% fat milk wherein the VD will be in CM
3% fat milk wherein the VD will be in CM
group 3
3% fat milk wherein the VD will be in CM
Placebo: un-enriched skimmilk.
Placebo: un-enriched skimmilk.
Group 4
Placebo: un-enriched skimmilk.
Interventions
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Group 1
Skimmilk enriched with VD encapsulated in CM
Group 2
VD will be dissolved in milkfat and homogenized into skimmilk
group 3
3% fat milk wherein the VD will be in CM
Group 4
Placebo: un-enriched skimmilk.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
65 Years
ALL
Yes
Sponsors
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Technion, Israel Institute of Technology
OTHER
Rambam Health Care Campus
OTHER
Responsible Party
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Rambam Health Care Campus
Other Identifiers
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3000007066
Identifier Type: -
Identifier Source: org_study_id