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
1 other identifier
interventional
120
0 countries
N/A
Brief 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 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2011
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 12, 2010
CompletedFirst Posted
Study publicly available on registry
December 14, 2010
CompletedStudy Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedDecember 14, 2010
December 1, 2010
11 months
December 12, 2010
December 13, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
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
1 year
Study Arms (4)
Skimmilk enriched with VD encapsulated in CM
ACTIVE COMPARATORVD will be dissolved in milkfat and homogenized into skimmilk
ACTIVE COMPARATORVD will be dissolved in milkfat and homogenized into skimmilk
3% fat milk wherein the VD will be in CM
ACTIVE COMPARATOR3% fat milk wherein the VD will be in CM
Placebo: un-enriched skimmilk.
ACTIVE COMPARATORPlacebo: un-enriched skimmilk.
Interventions
Skimmilk enriched with VD encapsulated in CM
VD will be dissolved in milkfat and homogenized into skimmilk
3% fat milk wherein the VD will be in CM
Eligibility Criteria
You may qualify if:
- Healthy volunteers
You may not qualify if:
- Metabolic disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 12, 2010
First Posted
December 14, 2010
Study Start
January 1, 2011
Primary Completion
December 1, 2011
Study Completion
May 1, 2012
Last Updated
December 14, 2010
Record last verified: 2010-12