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

NCT02543671 | Completed

• 1 other identifier: 613977
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypovitaminosis D; Deficiency of Micronutrients

Keywords

vitamin D status; 25-hydroxyvitamin D; cheese; Randomized controlled trial; postmenopausal women; enriched; vitamin D3

Outcome Measures

Primary Outcomes (1)

• serum 25-hydroxyvitamin D concentration

  8 weeks

Secondary Outcomes (8)

• physical functioning scale, Short Form 36 health survey questionnaire (SF-36)

  8 weeks

• role limitations due to physical health scale, Short Form 36 health survey questionnaire (SF-36)

  8 weeks

• role limitations due to emotional problems scale, Short Form 36 health survey questionnaire (SF-36)

  8 weeks

• vitality scale, Short Form 36 health survey questionnaire (SF-36)

  8 weeks

• emotional well-being scale, Short Form 36 health survey questionnaire (SF-36)

  8 weeks

Study Arms (2)

vitamin D3 enriched cheese

ACTIVE COMPARATOR

vitamin D3 enriched, reduced-fat yellow cheese

Other: vitamin D3 enriched, reduced-fat yellow cheese

plain cheese

PLACEBO COMPARATOR

plain (non-fortified) reduced-fat yellow cheese

Other: plain (non-fortified) reduced-fat yellow cheese

Interventions

vitamin D3 enriched, reduced-fat yellow cheese OTHER

60 grams of vitamin D3 enriched, reduced-fat yellow cheese provide 5.7 micrograms of vitamin D per day for 8 weeks

vitamin D3 enriched cheese

plain (non-fortified) reduced-fat yellow cheese OTHER

60 grams of plain (non-fortified), reduced-fat yellow cheese provide 0 micrograms of vitamin D per day for 8 weeks

plain cheese

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Harokopio University: lead
• University College Cork: collaborator
• FrieslandCampina: collaborator

Study Sites (1)

Harokopio University of Athens

Kallithea, Attica, 17671, Greece

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Yannis Manios, Associate Professor

  Harokopio University, Athens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 3, 2015
• First Posted: September 7, 2015
• Study Start: October 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: June 1, 2015
• Last Updated: September 7, 2015

Record last verified: 2015-09

Locations

GR (1)