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

Study Overview
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Brief Summary
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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
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Healthy Individuals

Intervention / Treatment
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* Dietary Supplement: Group 1
* Dietary Supplement: Group 2
* Dietary Supplement: group 3
* Dietary Supplement: Group 4


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers Exclusion Criteria: Metabolic disorder

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Skimmilk enriched with VD encapsulated in CM<br> | Dietary Supplement: Group 1<br>* Skimmilk enriched with VD encapsulated in CM<br>|
| Active Comparator: VD will be dissolved in milkfat and homogenized into skimmilk<br>VD will be dissolved in milkfat and homogenized into skimmilk | Dietary Supplement: Group 2<br>* VD will be dissolved in milkfat and homogenized into skimmilk<br>|
| Active Comparator: 3% fat milk wherein the VD will be in CM<br>3% fat milk wherein the VD will be in CM | Dietary Supplement: group 3<br>* 3% fat milk wherein the VD will be in CM<br>|
| Active Comparator: Placebo: un-enriched skimmilk.<br>Placebo: un-enriched skimmilk. | Dietary Supplement: Group 4<br>* Placebo: un-enriched skimmilk.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |