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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

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ClinicalTrials.gov Identifier: NCT01259570
Recruitment Status : Unknown
Verified December 2010 by Rambam Health Care Campus.
Recruitment status was:  Not yet recruiting
First Posted : December 14, 2010
Last Update Posted : December 14, 2010
Sponsor:
Collaborator:
Information provided by:

Study Description
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


Condition or disease Intervention/treatment
Healthy Individuals Dietary Supplement: Group 1 Dietary Supplement: Group 2 Dietary Supplement: group 3 Dietary Supplement: Group 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Study Start Date : January 2011
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
U.S. FDA Resources

Arms and Interventions

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
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
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.
Placebo: un-enriched skimmilk.
Dietary Supplement: Group 4
Placebo: un-enriched skimmilk.


Outcome Measures

Primary Outcome Measures :
  1. Bioavailability of vitamin D encapsulated in casein micelles, compared to its bioavailability in the milk-fat. [ Time Frame: 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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers

Exclusion Criteria:

  • Metabolic disorder
More Information

Responsible Party: Sophia Ish-Shalom, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01259570     History of Changes
Other Study ID Numbers: 3000007066
First Posted: December 14, 2010    Key Record Dates
Last Update Posted: December 14, 2010
Last Verified: December 2010