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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01259570

Enrollment

120

Registered

2010-12-14

Start date

2011-01-31

Completion date

2012-05-31

Last updated

2010-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Individuals

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

Interventions

DIETARY_SUPPLEMENTGroup 1

Skimmilk enriched with VD encapsulated in CM

DIETARY_SUPPLEMENTGroup 2

VD will be dissolved in milkfat and homogenized into skimmilk

DIETARY_SUPPLEMENTgroup 3

3% fat milk wherein the VD will be in CM

DIETARY_SUPPLEMENTGroup 4

Placebo: un-enriched skimmilk.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy volunteers

Exclusion criteria

* Metabolic disorder

Design outcomes

Primary

Measure	Time frame	Description
Bioavailability of vitamin D encapsulated in casein micelles, compared to its bioavailability in the milk-fat.	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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026