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

Rambam Health Care Campus120 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

120

Conditions

Healthy Individuals

Interventions

Skimmilk enriched with VD encapsulated in CM

Group 2DIETARY_SUPPLEMENT

VD will be dissolved in milkfat and homogenized into skimmilk

group 3DIETARY_SUPPLEMENT

3% fat milk wherein the VD will be in CM

Group 4DIETARY_SUPPLEMENT

Placebo: un-enriched skimmilk.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy volunteers Exclusion Criteria: * Metabolic disorder

Outcomes

Primary Outcomes

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

Time frame: 1 year

Data from ClinicalTrials.gov

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