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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01259570
Other study ID # 3000007066
Secondary ID
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


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
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