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

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

Study Overview

• Status: Unknown
• Conditions: Healthy Individuals
• Intervention / Treatment: Dietary supplement: Group 1; Dietary supplement: Group 2; Dietary supplement: group 3; Dietary supplement: Group 4

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy volunteers

Exclusion Criteria:

• Metabolic disorder

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus
• Collaborators: Technion, Israel Institute of Technology

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Anticipated): December 1, 2011
• Study Completion (Anticipated): May 1, 2012

Study Registration Dates

• First Submitted: December 12, 2010
• First Submitted That Met QC Criteria: December 13, 2010
• First Posted (Estimate): December 14, 2010

Study Record Updates

• Last Update Posted (Estimate): December 14, 2010
• Last Update Submitted That Met QC Criteria: December 13, 2010
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Other Study ID Numbers: 3000007066