Healthy
Conditions
Keywords
vitamin D, fortified oil
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.
Interventions
DIETARY_SUPPLEMENTfortified oil
35 g fortified sunflower oil
DIETARY_SUPPLEMENTPlacebo
plain oil
Sponsors
National Nutrition and Food Technology Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* 20 to 60 years * healthy subjects * no receiving vitamin D or omega-3 supplement in past 3 months
Exclusion criteria
\- receiving vitamin D or omega-3 supplement during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 25-hydroxyvitamin D (nmol/L) | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| serum triglyceride (mg/dL) | 8 weeks |
| serum total cholesterol (mg/dL) | 8 weeks |
| serum glucose (mg/dL) | 8 weeks |
| serum HDL | 8 weeks |
| serum PTH (pg/mL) | 8 weeks |
| serum LDL | 8 weeks |
Countries
Iran
Outcome results
None listed