Assessment of the Efficacy of Vitamin D-fortified Oil in Healthy Adults
- Conditions
- Healthy
- Registration Number
- NCT03826654
- 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 sunflower oil with vitamin D on serum 25-hydroxyvitamin D level, glycemic and lipidemic status in healthy subjects compared to plain oil.
- 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 two intervention groups: 1.fortified sunflower oil, 2. plain bread+vitamin D supplements,3. plain bread+placebo. Each participant will consume 50 g of oil every day for 2 months.
At the first and last visits, dietary and laboratory assessments will be performed for all subjects. Primary outcomes are the improvement in vitamin D status and secondary outcome is the 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 60 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 triglyceride (mg/dL) 8 weeks serum LDL 8 weeks serum HDL 8 weeks serum PTH (pg/mL) 8 weeks
Trial Locations
- Locations (1)
Laboratory of Nutrition Research, National Nutrition and Food Technology Research Institute (NNFTRI) and Faculty of Nutrition Science and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran
🇮🇷Tehran, Iran, Islamic Republic of
Laboratory of Nutrition Research, National Nutrition and Food Technology Research Institute (NNFTRI) and Faculty of Nutrition Science and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran🇮🇷Tehran, Iran, Islamic Republic of