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 Campus

Status: Unknown

Conditions: Healthy Individuals

Treatments: Dietary Supplement: group 3; Dietary Supplement: Group 4; Dietary Supplement: Group 1; Dietary Supplement: Group 2

Study type: Interventional

Funder types: Other

Identifiers

NCT01259570

3000007066

Details and patient eligibility

About

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

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy volunteers

Exclusion criteria

• Metabolic disorder

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 4 patient groups

Skimmilk enriched with VD encapsulated in CM

Active Comparator group

Treatment:

Dietary Supplement: Group 1

VD will be dissolved in milkfat and homogenized into skimmilk

Active Comparator group

Description:

VD will be dissolved in milkfat and homogenized into skimmilk

Treatment:

Dietary Supplement: Group 2

3% fat milk wherein the VD will be in CM

Active Comparator group

Description:

3% fat milk wherein the VD will be in CM

Treatment:

Dietary Supplement: group 3

Placebo: un-enriched skimmilk.

Active Comparator group

Description:

Placebo: un-enriched skimmilk.

Treatment:

Dietary Supplement: Group 4