Clinical trial NCT02543671: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hypovitaminosis D
Deficiency of Micronutrients
Keywords: vitamin D status
25-hydroxyvitamin D
cheese
Randomized controlled trial
postmenopausal women
enriched
vitamin D3
Lead sponsor: Harokopio University
Sponsor class: OTHER
Collaborators: name: University College Cork
name: FrieslandCampina
First posted: 2015-09-07
Enrollment: 80
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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. .

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

Primary outcomes:
measure: serum 25-hydroxyvitamin D concentration
timeFrame: 8 weeks
Secondary outcomes:
measure: physical functioning scale, Short Form 36 health survey questionnaire (SF-36)
timeFrame: 8 weeks
measure: role limitations due to physical health scale, Short Form 36 health survey questionnaire (SF-36)
timeFrame: 8 weeks
measure: role limitations due to emotional problems scale, Short Form 36 health survey questionnaire (SF-36)
timeFrame: 8 weeks
measure: vitality scale, Short Form 36 health survey questionnaire (SF-36)
timeFrame: 8 weeks
measure: emotional well-being scale, Short Form 36 health survey questionnaire (SF-36)
timeFrame: 8 weeks
measure: social functioning scale, Short Form 36 health survey questionnaire (SF-36)
timeFrame: 8 weeks
measure: bodily pain scale, Short Form 36 health survey questionnaire (SF-36)
timeFrame: 8 weeks
measure: general health scale, Short Form 36 health survey questionnaire (SF-36)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Kallithea
country: Greece
facility: Harokopio University of Athens
state: Attica
Study officials:
affiliation: Harokopio University, Athens
name: Yannis Manios, Associate Professor
role: PRINCIPAL_INVESTIGATOR
References: