Assessment of the Efficacy of Vitamin D-fortified Bread in Healthy Adults
- Conditions
- Healthy
- Registration Number
- NCT02516254
- Lead Sponsor
- National Nutrition and Food Technology Institute
- Brief Summary
The aim of this study is to evaluate the efficacy of daily intake of fortified bread with vitamin D on serum 25-hydroxyvitamin D level, glycemic and lipidemic status in healthy subjects compared to vitamin D supplement.
- Detailed Description
Sixty apparently healthy subjects will be selected. Participants who are receiving vitamin D, calcium or omega-3 supplements within the last three months will be excluded. Subjects will be assigned randomly to one of the three intervention groups: 1.fortified bread+placebo,2. plain bread+vitamin D supplements,3. plain bread+placebo. Each participant will consume 50 g of bread and supplement or placebo every day for 2 months.
At the first and last visits, dietary and laboratory assessments will be performed for all subjects. Primary outcomes are improvement in vitamin D status and secondary outcome is improvement of glycemic and lipidemic markers and prevention of problems related to hypovitaminosis D.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 20 to 50 years
- healthy subjects
- no receiving vitamin D or omega-3 supplement in past 3 months
- receiving vitamin D or omega-3 supplement during the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 25-hydroxyvitamin D (nmol/L) 8 weeks
- Secondary Outcome Measures
Name Time Method serum glucose (mg/dL) 8 weeks serum total cholesterol (mg/dL) 8 weeks serum LDL 8 weeks serum triglyceride (mg/dL) 8 weeks serum PTH (pg/mL) 8 weeks serum HDL (mg/dL) 8 weeks