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

Healthy Individuals Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01259570
• Other study ID #: 3000007066
• Status: Not yet recruiting
• Phase: N/A
• First received: December 12, 2010
• Last updated: December 13, 2010
• Start date: January 2011
• Est. completion date: May 2012

Study information

• Verified date: December 2010
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: May 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Healthy volunteers

Exclusion Criteria:

• Metabolic disorder

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy Individuals

Intervention

Dietary Supplement:
• Group 1
Skimmilk enriched with VD encapsulated in CM
• Group 2
VD will be dissolved in milkfat and homogenized into skimmilk
• group 3
3% fat milk wherein the VD will be in CM
• Group 4
Placebo: un-enriched skimmilk.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Rambam Health Care Campus	Technion, Israel Institute of Technology

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes