An interventional study of Group 1 and Group 2 in Healthy Individuals, sponsored by Rambam Health Care Campus. Status unknown. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-12-14.
Sponsored by Rambam Health Care Campus · Not applicable, Interventional, and Prevention
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
Rambam Health Care Campus is the lead sponsor of 456 studies on the registry; 33 are open to participants now.
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Exclusion Criteria:
Dietary Supplement: Group 1
VD will be dissolved in milkfat and homogenized into skimmilk
Dietary Supplement: Group 2
3% fat milk wherein the VD will be in CM
Dietary Supplement: group 3
Placebo: un-enriched skimmilk.
Dietary Supplement: Group 4
Skimmilk enriched with VD encapsulated in CM
VD will be dissolved in milkfat and homogenized into skimmilk
3% fat milk wherein the VD will be in CM
Placebo: un-enriched skimmilk.
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
No study locations are listed for this record.
This study is status unknown, as verified in Dec 2010. You cannot join it, but the record below documents what was studied.
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Rambam Health Care Campus