Investigation of Vitamin D3 Enriched, Reduced-fat Yellow Cheese Efficacy to Prevent Vitamin D Deficiency

September 4, 2015 updated by: Yannis Manios, Harokopio University
The primary aim of the current study was to investigate whether the consumption of vitamin D3 enriched, reduced-fat yellow cheese can counterbalance the expected decrease in serum 25-hydroxyvitamin D concentration during winter in postmenopausal women in Greece, and in what degree it can contribute as a potential food-based strategy for the prevention of vitamin D deficiency. A secondary aim was also to investigate any potential effect of the intervention in several quality of life (QoL) indices in the population of postmenopausal women under study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Vitamin D status in postmenopausal women is of interest because of the association of low vitamin D status with increased risk of osteoporosis and related fractures. In addition, since there is increasing evidence that the dietary supply is often insufficient to offset the seasonal deficit in sunlight during winter months, fortified food and supplements are becoming important sources of dietary vitamin D intake to achieve optimal vitamin D status, especially in this high risk population. Although most studies have examined the effectiveness of vitamin D enriched milk and yogurt, there have been limited studies also exploring the effectiveness of vitamin D enriched cheese in enhancing vitamin D status and preventing vitamin D deficiency. However, fortification of cheese with vitamin D has certain technological considerations, particularly for reduced-fat varieties considering that vitamin D is a fat soluble nutrient.

The primary aim of the current study was to investigate whether the consumption of vitamin D3 enriched, reduced-fat yellow cheese can counterbalance the expected decrease in serum 25-hydroxyvitamin D concentration during winter in postmenopausal women in Greece, and in what degree it can contribute as a potential food-based strategy for the prevention of vitamin D deficiency. A secondary aim was also to investigate any potential effect of the intervention in several quality of life (QoL) indices in the population of postmenopausal women under study. .

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Attica
      • Kallithea, Attica, Greece, 17671
        • Harokopio University of Athens

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • subjects are eligible if they are 55-75 years of age
  • being at menopause for more than 5 years
  • they used to consume cheese daily
  • those with a Body Mass Index (BMI) range 20-33kg/m2

Exclusion Criteria:

  • having any disease/ pathology that interacts with vitamin D metabolism
  • taking medications that interact with vitamin D metabolism or vitamin D supplements for medical reasons (e.g. osteoporosis)
  • planned vacation to a sunny holiday destination during the intervention period
  • having a cow's milk allergy
  • having a drugs and/or alcohol abuse

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: vitamin D3 enriched cheese
vitamin D3 enriched, reduced-fat yellow cheese
Other: vitamin D3 enriched, reduced-fat yellow cheese
60 grams of vitamin D3 enriched, reduced-fat yellow cheese provide 5.7 micrograms of vitamin D per day for 8 weeks
Placebo Comparator: plain cheese
plain (non-fortified) reduced-fat yellow cheese
Other: plain (non-fortified) reduced-fat yellow cheese
60 grams of plain (non-fortified), reduced-fat yellow cheese provide 0 micrograms of vitamin D per day for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
serum 25-hydroxyvitamin D concentration
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
physical functioning scale, Short Form 36 health survey questionnaire (SF-36)
Time Frame: 8 weeks
score range from 0 [worst disability related to physical functioning] to 100 [no disability related to physical functioning]
8 weeks
role limitations due to physical health scale, Short Form 36 health survey questionnaire (SF-36)
Time Frame: 8 weeks
score range from 0 [worst disability related to limitations due to physical health] to 100 [no disability related to limitations due to physical health]
8 weeks
role limitations due to emotional problems scale, Short Form 36 health survey questionnaire (SF-36)
Time Frame: 8 weeks
score range from 0 [worst disability related to limitations due to emotional problems] to 100 [no disability related to limitations due to emotional problems]
8 weeks
vitality scale, Short Form 36 health survey questionnaire (SF-36)
Time Frame: 8 weeks
score range from 0 [worst disability related to vitality to 100 [no disability related to vitality]
8 weeks
emotional well-being scale, Short Form 36 health survey questionnaire (SF-36)
Time Frame: 8 weeks
score range from 0 [worst disability related to emotional well-being to 100 [no disability related to emotional well-being]
8 weeks
social functioning scale, Short Form 36 health survey questionnaire (SF-36)
Time Frame: 8 weeks
score range from 0 [worst disability related to social functioning to 100 [no disability related to social functioning]
8 weeks
bodily pain scale, Short Form 36 health survey questionnaire (SF-36)
Time Frame: 8 weeks
score range from 0 [worst disability related to bodily pain] to 100 [no disability related to bodily pain]
8 weeks
general health scale, Short Form 36 health survey questionnaire (SF-36)
Time Frame: 8 weeks
score range from 0 [worst general health] to 100 [best general health]
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Harokopio University

Collaborators

University College Cork
FrieslandCampina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

September 3, 2015

First Submitted That Met QC Criteria

September 4, 2015

First Posted (Estimate)

September 7, 2015

Study Record Updates

Last Update Posted (Estimate)

September 7, 2015

Last Update Submitted That Met QC Criteria

September 4, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 613977

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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