Formulation of Vitamin D-fortified Sunflower Oil and Evaluation of the Efficacy of Its Consumption in Healthy Adults: a Randomized Controlled Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- 25-hydroxyvitamin D (nmol/L)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 60 Years (Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
fortified oil
daily intake of fortified sunflower oil (700IU vitamin D/ 35g)
Intervention: fortified oil (Dietary Supplement)
control
daily intake of plain oil
Intervention: Placebo (Dietary Supplement)
Outcomes
Primary Outcomes
25-hydroxyvitamin D (nmol/L)
Time Frame: 8 weeks
Secondary Outcomes
- serum triglyceride (mg/dL)(8 weeks)
- serum LDL(8 weeks)
- serum HDL(8 weeks)
- serum PTH (pg/mL)(8 weeks)
- serum glucose (mg/dL)(8 weeks)
- serum total cholesterol (mg/dL)(8 weeks)
Investigators
Tirang R. Neyestani, Ph.D.
Prof.
National Nutrition and Food Technology Institute