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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fortified bread | Experimental | daily intake of fortified bread (1000IU vitamin D per 50 g) plus placebo |
|
| supplement | Experimental | daily intake of plain bread (50 g) plus supplement (1000 IU per tablet) |
|
| placebo | Placebo Comparator | daily intake of plain bread plus placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fortified bread | Dietary Supplement | 50 g of fortified bread + placebo daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 25-hydroxyvitamin D (nmol/L) | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| serum glucose (mg/dL) | 8 weeks | |
| serum triglyceride (mg/dL) | 8 weeks | |
| serum total cholesterol (mg/dL) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tirang R. Neyestani, PhD | 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 | Study Chair |
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| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| supplement | Dietary Supplement | vitamin D supplement+ plain bread |
|
|
| placebo | Dietary Supplement | plain bread+placebo |
|
|
| 8 weeks |
| serum LDL | 8 weeks |
| serum HDL (mg/dL) | 8 weeks |
| serum PTH (pg/mL) | 8 weeks |
| D009750 |
| Nutritional and Metabolic Diseases |