Healthy Clinical Trial
Official title:
Formulation of Vitamin D-fortified Sunflower Oil and Evaluation of the Efficacy of Its Consumption in Healthy Adults: a Randomized Controlled Clinical Trial
NCT number | NCT03826654 |
Other study ID # | 24 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 1, 2018 |
Est. completion date | July 1, 2018 |
Verified date | January 2019 |
Source | National Nutrition and Food Technology Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | July 1, 2018 |
Est. primary completion date | April 1, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 60 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
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 |
Lead Sponsor | Collaborator |
---|---|
National Nutrition and Food Technology Institute |
Iran, Islamic Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 25-hydroxyvitamin D (nmol/L) | 8 weeks | ||
Secondary | serum glucose (mg/dL) | 8 weeks | ||
Secondary | serum triglyceride (mg/dL) | 8 weeks | ||
Secondary | serum total cholesterol (mg/dL) | 8 weeks | ||
Secondary | serum LDL | 8 weeks | ||
Secondary | serum HDL | 8 weeks | ||
Secondary | serum PTH (pg/mL) | 8 weeks |
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