Bioavailability of Vitamin D Encapsulated in Casein Micelles, Compared to Its Bioavailability in a Synthetic Emulsifier Currently Used for Supplementation and Enrichment. (VD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Rambam Health Care Campus
Sponsor:
Information provided by (Responsible Party):
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01807845
First received: March 7, 2013
Last updated: March 13, 2013
Last verified: March 2013
  Purpose

Background: Vitamin D3 (VD) is an oil soluble vitamin formed in the skin during exposure to UV light. It is essential for bone and calcium metabolism, insulin reactivity, immune system etc. The dietary sources of VD are scarce, and insufficient. Epidemiological studies link proper VD status with lower risks of bone fracture, hypertension, diabetes, cancer and more. VD deficiency is widespread, mainly due to avoidance of sun exposure due to fear of melanoma. Therefore there is an urgent need to enrich staple foods & beverages with VD, to prevent deficiency.

A novel technology was developed , for nanoencapsulating VD within casein micelles (CM) (natural milk protein nanoparticles). Previously we have found that the bioavailability of VD in CM in 1% fat milk was similar to that in an aqueous dietary supplement based on a synthetic emulsifier- Tween 80- which is sometimes used by the industry to add VD into milk.

The main research question studied in the current project is: how will the bioavailability of VD be affected by its delivery in CM compared to its delivery using Tween 80 in a fat free milk product, like nonfat yogurt.

Hypothesis: The open molecular structure of caseins, which evolved to be easily digestible, may facilitate the bioavailability of VD nanoencapsulated in CM, so that it will not be less than that in Tween 80, which is considered to be good. CM are particularly useful for oil-soluble micronutrient delivery in non-fat products. The most widely consumed nonfat milk product is 0% fat yoghurt, chosen it for this study.

Methods: Yoghurts will be made from 3 milk formulations:

  1. Skim milk (0% fat) enriched with 50,000 international units (IU) VD in 150 gr product, in CM.
  2. Skim milk with same dosage of VD, emulsified with Tween 80.
  3. Placebo: skim milk without added VD. 90 healthy adults, aged 18-65, having passed a medical qualification examination, will be randomly assigned to 3 groups. Following over-night fasting they will each consume a 150 gr yoghurt sample as detailed above, and be requested to fast 2 more hours. Blood will be sampled before yoghurt consumption, and after 1, 7 and 14 days following consumption. Blood-serum level of 25(OH)D (the form of VD used as a status indicator in routine blood tests), by chemiluminescence immunoassay (CMIA).

Expected findings: The bioavailability of VD in CM will not be lower than that in Tween 80, in 0% fat yoghurt.

Significance of the study: With the widespread VD deficiency, decreased fat consumption and rising demand for using only natural ingredients there is great importance in delivery of VD and other fat-soluble micronutrients in protein-based delivery systems, like CM, instead of using synthetic emulsifiers, and it is imperative to assure the bioavailability is not compromised by this dramatic change.

CM solubilize VD and help uniformly distribute it in aqueous products and protect it against heat, oxidation and UV.


Condition Intervention
Vitamin D Deficiency
Dietary Supplement: enriched skimmilk with VD
Dietary Supplement: Skimmilk enriched with VD wherein the VD will be emulsified using Tween 80
Dietary Supplement: Placebo: un-enriched skimmilk.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • Serum 25(OH)D level [ Time Frame: 0, 1 day, 7 days, 14 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 90
Study Start Date: January 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Skimmilk VD will be emulsified using Tween 80
Skimmilk enriched with VD wherein the VD will be emulsified using Tween 80;
Dietary Supplement: Skimmilk enriched with VD wherein the VD will be emulsified using Tween 80
Skimmilk enriched with VD wherein the VD will be emulsified using Tween 80
Placebo Comparator: Placebo: un-enriched skimmilk.
Placebo: un-enriched skimmilk.
Dietary Supplement: Placebo: un-enriched skimmilk.
Placebo: un-enriched skimmilk
Active Comparator: enriched skimmilk with VD
enriched skimmilk with VD
Dietary Supplement: enriched skimmilk with VD
enriched skimmilk with VD

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Healthy volunteers . adults aged 18 - 65

Exclusion Criteria:

Intestinal malabsorption, lactose intolerance, medical illness (e.g. liver disease, kidney disease, or diabetes), hypercalcemia, excessive alcohol use, pregnancy, use of medications known to interfere with vitamin D metabolism e.g. anticonvulsants, barbiturates, or steroids), granulomatous disease, use of vitamin D supplements, potential for significant sun exposure (e.g., travel to a sunny vacation site or use of tanning beds) within the month prior to, or during, the study. -

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01807845

Contacts
Contact: SOFIA ISH-SHALOM, MD 972-4-8543033 s_ish_shalom@rambam.health.gov.il
Contact: YOAV LIVNEY, MD 972-0778874225 LIVNEY@TECHNION.AC.IL

Locations
Israel
Rambam-Health Care Campus Recruiting
Haifa, Israel, 31096
Contact: YOAV LIVNEY, MD    972 778874225    livney@technion.ac.il   
Principal Investigator: SOFIA ISH-SHALOM, MD         
Sub-Investigator: YOAV LIVNEY, MD         
Sponsors and Collaborators
Rambam Health Care Campus
  More Information

No publications provided

Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01807845     History of Changes
Other Study ID Numbers: No. 1-Version 1.
Study First Received: March 7, 2013
Last Updated: March 13, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Rambam Health Care Campus:
Casein micelles
vitamin D3 (cholecalciferol)
Bioavailability
Nanoencapsulation
Nutrition

Additional relevant MeSH terms:
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on September 18, 2014