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

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-05-31

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

Detailed Description

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Conditions

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Healthy Individuals

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Skimmilk enriched with VD encapsulated in CM

Group Type ACTIVE_COMPARATOR

Group 1

Intervention Type DIETARY_SUPPLEMENT

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 Type ACTIVE_COMPARATOR

Group 2

Intervention Type DIETARY_SUPPLEMENT

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 Type ACTIVE_COMPARATOR

group 3

Intervention Type DIETARY_SUPPLEMENT

3% fat milk wherein the VD will be in CM

Placebo: un-enriched skimmilk.

Placebo: un-enriched skimmilk.

Group Type ACTIVE_COMPARATOR

Group 4

Intervention Type DIETARY_SUPPLEMENT

Placebo: un-enriched skimmilk.

Interventions

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Group 1

Skimmilk enriched with VD encapsulated in CM

Intervention Type DIETARY_SUPPLEMENT

Group 2

VD will be dissolved in milkfat and homogenized into skimmilk

Intervention Type DIETARY_SUPPLEMENT

group 3

3% fat milk wherein the VD will be in CM

Intervention Type DIETARY_SUPPLEMENT

Group 4

Placebo: un-enriched skimmilk.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Healthy volunteers

Exclusion Criteria

* Metabolic disorder
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Technion, Israel Institute of Technology

OTHER

Sponsor Role collaborator

Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

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Rambam Health Care Campus

Other Identifiers

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3000007066

Identifier Type: -

Identifier Source: org_study_id