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

Not Applicable

• Conditions: Healthy Individuals
• Interventions: Dietary Supplement: group 3; Dietary Supplement: Group 4; Dietary Supplement: Group 1; Dietary Supplement: Group 2

• Registration Number: NCT01259570
• Lead Sponsor: Rambam Health Care Campus

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-12
• Study First Submitted: 2010-12-12
• Study First Submitted QC: 2010-12-13
• Last Update Submitted: 2010-12-13
• Study First Posted: 2010-12-14
• Last Update Posted: 2010-12-14
• Study Start: 2011-01
• Primary Completion: 2011-12
• Study Completion: 2012-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Healthy volunteers

Exclusion Criteria

• Metabolic disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
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.	Group 4	Placebo: un-enriched skimmilk.
Skimmilk enriched with VD encapsulated in CM	Group 1	-
VD will be dissolved in milkfat and homogenized into skimmilk	Group 2	VD will be dissolved in milkfat and homogenized into skimmilk

Primary Outcome Measures

Name	Time	Method
Bioavailability of vitamin D encapsulated in casein micelles, compared to its bioavailability in the milk-fat.	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