Investigation of Vitamin D3 Enriched, Reduced-fat Yellow Cheese Efficacy to Prevent Vitamin D Deficiency
Primary Purpose
Hypovitaminosis D, Deficiency of Micronutrients
Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
vitamin D3 enriched, reduced-fat yellow cheese
plain (non-fortified) reduced-fat yellow cheese
Sponsored by
About this trial
This is an interventional prevention trial for Hypovitaminosis D focused on measuring vitamin D status, 25-hydroxyvitamin D, cheese, Randomized controlled trial, postmenopausal women, enriched, vitamin D3
Eligibility Criteria
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
Sites / Locations
- Harokopio University of Athens
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
vitamin D3 enriched cheese
plain cheese
Arm Description
vitamin D3 enriched, reduced-fat yellow cheese
plain (non-fortified) reduced-fat yellow cheese
Outcomes
Primary Outcome Measures
serum 25-hydroxyvitamin D concentration
Secondary Outcome Measures
physical functioning scale, Short Form 36 health survey questionnaire (SF-36)
score range from 0 [worst disability related to physical functioning] to 100 [no disability related to physical functioning]
role limitations due to physical health scale, Short Form 36 health survey questionnaire (SF-36)
score range from 0 [worst disability related to limitations due to physical health] to 100 [no disability related to limitations due to physical health]
role limitations due to emotional problems scale, Short Form 36 health survey questionnaire (SF-36)
score range from 0 [worst disability related to limitations due to emotional problems] to 100 [no disability related to limitations due to emotional problems]
vitality scale, Short Form 36 health survey questionnaire (SF-36)
score range from 0 [worst disability related to vitality to 100 [no disability related to vitality]
emotional well-being scale, Short Form 36 health survey questionnaire (SF-36)
score range from 0 [worst disability related to emotional well-being to 100 [no disability related to emotional well-being]
social functioning scale, Short Form 36 health survey questionnaire (SF-36)
score range from 0 [worst disability related to social functioning to 100 [no disability related to social functioning]
bodily pain scale, Short Form 36 health survey questionnaire (SF-36)
score range from 0 [worst disability related to bodily pain] to 100 [no disability related to bodily pain]
general health scale, Short Form 36 health survey questionnaire (SF-36)
score range from 0 [worst general health] to 100 [best general health]
Full Information
NCT ID
NCT02543671
First Posted
September 3, 2015
Last Updated
September 4, 2015
Sponsor
Harokopio University
Collaborators
University College Cork, FrieslandCampina
1. Study Identification
Unique Protocol Identification Number
NCT02543671
Brief Title
Investigation of Vitamin D3 Enriched, Reduced-fat Yellow Cheese Efficacy to Prevent Vitamin D Deficiency
Official Title
Investigation of Vitamin D3 Enriched, Reduced-fat Yellow Cheese Efficacy to Prevent Vitamin D Deficiency
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harokopio University
Collaborators
University College Cork, FrieslandCampina
4. Oversight
5. Study Description
Brief Summary
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.
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. .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypovitaminosis D, Deficiency of Micronutrients
Keywords
vitamin D status, 25-hydroxyvitamin D, cheese, Randomized controlled trial, postmenopausal women, enriched, vitamin D3
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
vitamin D3 enriched cheese
Arm Type
Active Comparator
Arm Description
vitamin D3 enriched, reduced-fat yellow cheese
Arm Title
plain cheese
Arm Type
Placebo Comparator
Arm Description
plain (non-fortified) reduced-fat yellow cheese
Intervention Type
Other
Intervention Name(s)
vitamin D3 enriched, reduced-fat yellow cheese
Intervention Description
60 grams of vitamin D3 enriched, reduced-fat yellow cheese provide 5.7 micrograms of vitamin D per day for 8 weeks
Intervention Type
Other
Intervention Name(s)
plain (non-fortified) reduced-fat yellow cheese
Intervention Description
60 grams of plain (non-fortified), reduced-fat yellow cheese provide 0 micrograms of vitamin D per day for 8 weeks
Primary Outcome Measure Information:
Title
serum 25-hydroxyvitamin D concentration
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
physical functioning scale, Short Form 36 health survey questionnaire (SF-36)
Description
score range from 0 [worst disability related to physical functioning] to 100 [no disability related to physical functioning]
Time Frame
8 weeks
Title
role limitations due to physical health scale, Short Form 36 health survey questionnaire (SF-36)
Description
score range from 0 [worst disability related to limitations due to physical health] to 100 [no disability related to limitations due to physical health]
Time Frame
8 weeks
Title
role limitations due to emotional problems scale, Short Form 36 health survey questionnaire (SF-36)
Description
score range from 0 [worst disability related to limitations due to emotional problems] to 100 [no disability related to limitations due to emotional problems]
Time Frame
8 weeks
Title
vitality scale, Short Form 36 health survey questionnaire (SF-36)
Description
score range from 0 [worst disability related to vitality to 100 [no disability related to vitality]
Time Frame
8 weeks
Title
emotional well-being scale, Short Form 36 health survey questionnaire (SF-36)
Description
score range from 0 [worst disability related to emotional well-being to 100 [no disability related to emotional well-being]
Time Frame
8 weeks
Title
social functioning scale, Short Form 36 health survey questionnaire (SF-36)
Description
score range from 0 [worst disability related to social functioning to 100 [no disability related to social functioning]
Time Frame
8 weeks
Title
bodily pain scale, Short Form 36 health survey questionnaire (SF-36)
Description
score range from 0 [worst disability related to bodily pain] to 100 [no disability related to bodily pain]
Time Frame
8 weeks
Title
general health scale, Short Form 36 health survey questionnaire (SF-36)
Description
score range from 0 [worst general health] to 100 [best general health]
Time Frame
8 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yannis Manios, Associate Professor
Organizational Affiliation
Harokopio University, Athens
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harokopio University of Athens
City
Kallithea
State/Province
Attica
ZIP/Postal Code
17671
Country
Greece
12. IPD Sharing Statement
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Investigation of Vitamin D3 Enriched, Reduced-fat Yellow Cheese Efficacy to Prevent Vitamin D Deficiency
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