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The objective of this study is to test the bioavailability of vitamin D in bread.
Vitamin D helps in reducing the risk for the development of many chronic diseases. Humans get vitamin D mainly from direct exposure to sunlight, from diet, or from dietary supplements. The bioavailability of vitamin D from dietary supplements has been tested. In one study, subjects had initial vitamin D level of less than 10ng/ml, and it rose to 60ng/ml 24 hours after taking a vitamin D supplement capsule that contained 50,000 IU of vitamin D2. Food contains vitamin D2 or vitamin D3 either naturally or after being fortified. Fortification of dietary products date back to the first half of the 20th century when Steenbock discovered that irradiation of food helped in promoting the healing of rickets in vitamin D deficient rachitic rats. Since that time, companies started to fortify their products to enhance their vitamin D content. In the 1930s Bond Bread fortified its bread with vitamin D2. Recently the FDA approved yeast vitamin D2 which is a yeast that was exposed to ultraviolet radiation. This yeast is active and when used to raise bread the bread contains vitamin D2. The baking process does not affect the vitamin D content. What is unknown is whether the vitamin D2 that is produced in the bread is bioavailable. The purpose of this study is to determine the bioavailability of vitamin D2 that is present in yeast, in bread that was raised with vitamin D2 yeast and vitamin D2 in the cell walls of yeast compared to a vitamin D2 supplement and a vitamin D3 supplement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | 50,000 IU of crystalline D2 in 5 capsules.. Vitamin D2 in its natural state consumed orally via capsule |
|
| B | Active Comparator | 50,000 IU of crystalline D3 in 5 capsules.. Vitamin D3 in its natural state consumed orally via capsule |
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| C | Active Comparator | 50,000 IU of vitamin D2 from vitamin D2 yeast in 5 capsules. Vitamin D generated in yeast. Acts as a comparator to the yeast in bread. |
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| D | Active Comparator | 50,000 IU of vitamin D2 from yeast cell walls in 5 capsules. Yeast cell walls rich in Vitamin D. Acts as a comparator to the yeast in bread. |
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| E | Experimental | 50,000 IU of vitamin D2 from 2 slices of bread made from bread. Bread raised with yeast rich in vitamin D. Main experimental arm. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Consumption of capsule/bread with vitamin D | Other |
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| Measure | Description | Time Frame |
|---|---|---|
| Evidence of serum vitamin D levels proceeding ingestion of bread raised with yeast containing vitamin D | The subject blood will be monitored at the above mentioned time frame after consuming vitamin D in capsular or bread form. | within the fist 24, 48, 72, 96, and 144 hours after ingestion |
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Inclusion Criteria:
Exclusion Criteria:
1. Having history of hypercalcemia. 2. Taking over the counter or prescription vitamin D that is greater than 10,000 IUs daily.
3. Pregnancy. 4. History of intestinal malabsorption. 5. Inability to give informed consent. 6. Chronic hepatic or renal failure. 7. Subjects taking cholestyramine and olestra. 8. Celiac disease. 9. Allergy to wheat or gluten sensitivity.
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| ID | Term |
|---|---|
| D001939 | Bread |
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| F | Experimental | 50,000 IU of vitamin D2 from 2 slices of bread. Bread raised with yeast and yeast cell walls rich in vitamin D. |
|
| D012632 |
| Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |