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

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ClinicalTrials.gov Identifier: NCT02543671
Recruitment Status : Completed
First Posted : September 7, 2015
Last Update Posted : September 7, 2015
Sponsor:
Collaborators:
University College Cork
FrieslandCampina
Information provided by (Responsible Party):
Yannis Manios, Harokopio University

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.

Condition or disease Intervention/treatment Phase
Hypovitaminosis D Deficiency of Micronutrients Other: vitamin D3 enriched, reduced-fat yellow cheese Other: plain (non-fortified) reduced-fat yellow cheese Not Applicable

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. .

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Investigation of Vitamin D3 Enriched, Reduced-fat Yellow Cheese Efficacy to Prevent Vitamin D Deficiency
Study Start Date : October 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : June 2015


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




Primary Outcome Measures :
  1. serum 25-hydroxyvitamin D concentration [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. 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]

  2. 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]

  3. 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]

  4. 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]

  5. 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]

  6. 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]

  7. 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. 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]



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Ages Eligible for Study:   55 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02543671


Locations
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Greece
Harokopio University of Athens
Kallithea, Attica, Greece, 17671
Sponsors and Collaborators
Harokopio University
University College Cork
FrieslandCampina
Investigators
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Principal Investigator: Yannis Manios, Associate Professor Harokopio University, Athens
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Responsible Party: Yannis Manios, Associate Professor, Harokopio University
ClinicalTrials.gov Identifier: NCT02543671    
Other Study ID Numbers: 613977
First Posted: September 7, 2015    Key Record Dates
Last Update Posted: September 7, 2015
Last Verified: September 2015
Keywords provided by Yannis Manios, Harokopio University:
vitamin D status
25-hydroxyvitamin D
cheese
Randomized controlled trial
postmenopausal women
enriched
vitamin D3
Additional relevant MeSH terms:
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Rickets
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Calcium Metabolism Disorders
Vitamin D
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents