Vitamin D3 Deficiency
Conditions
Keywords
vitamin D, ergosterol, 7-dehydro-cholesterol, wheat germ oil
Brief summary
The interventional study will evaluate effectiveness and potential of a regularly consumption of wheat germ oil (UV treated) vs. wheat germ oil (UV untreated) to increase plasma vitamin D levels ín humans.
Detailed description
The interventional study in parallel design will evaluate the effectiveness and potential of a daily consumption of wheat germ oil (UV treated vs. untreated) to increase plasma vitamin D levels in humans. Wheat germ oil is naturally rich in vitamin D precursors (ergosterol and 7-dehydrocholesterol), which are converted into vitamin D2 and vitamin D3 by a defined UV light irradiation for the present study. Half of the participants will consume UV-treated wheat germ oil (intervention) and the other part will consume traditional wheat germ oil (untreated, control). The subjects will consume 10 ml of wheat germ oil per day over an entire period of 6 weeks (no follow-up). On the basis of the planned human intervention study (randomized, single-blind, parallel design) it will be investigated to what extent a regular consumption of wheat germ oil (UV-treated) can contribute to the increase of plasma 25 (OH) D levels. The comparison is made against the intake of traditional (untreated) wheat germ oil (control). The study fits with the strategy of the Competence Cluster for Nutrition and Cardiovascular Health (nutriCARD), Halle-Jena-Leipzig, Germany (www.nutriCARD.de) and the study collaborators are active members of the nutriCARD cluster.
Interventions
DIETARY_SUPPLEMENTWheat germ oil (UV treated)
Wheat germ oil is naturally rich in vitamin D precursors (ergosterol and 7-dehydrocholesterol), which are converted into vitamin D2 and vitamin D3 by a defined UV light irradiation for the present study (wheat germ oil (UV treated). The wheat germ oil (UV treated) is dispensed in dark glass bottles without label. The distinction between the groups is based on the expiration date (08.05.2018 vs. 09.05.2018). The distinction between the groups is not possible for the participants. The daily dosage of wheat germ oil is 10 ml and the study products will be consumed over an entire period of 6 weeks (no follow-up). Recommendation for intake: pure before a main meal.
DIETARY_SUPPLEMENTWheat germ oil (untreated)
commercial available wheat germ oil The wheat germ oil (untreated) is dispensed in dark glass bottles without label. The distinction between the groups is based on the expiration date (08.05.2018 vs. 09.05.2018). The distinction between the groups is not possible for the participants. The daily dosage of wheat germ oil is 10 ml and the study products will be consumed over an entire period of 6 weeks (no follow-up). Recommendation for intake: pure before a main meal.
Sponsors
Martin-Luther-Universität Halle-Wittenberg
University of Jena
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
The wheat germ oil is dispensed in dark glass bottles without label. The distinction between the groups is based on the expiration date (08.05.2018 vs. 09.05.2018).
Intervention model description
The randomized, single-blind human intervention study will be conducted in parallel design. Half of the participants (n = 17) will consume wheat germ oil UV-treated (intervention) and half of the participants (n = 17) will consume wheat germ oil untreated (placebo). The daily dosage of wheat germ oil is 10 ml and the study products will be consumed over an entire period of 6 weeks (no follow-up). The third group (n = 16) do not receive any study products (control).
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* healthy subjects * plasma 25(OH) vitamin D \< 50 nmol/l * nutritional habits: western diet
Exclusion criteria
* intake of lipid-lowering medications * gastrointestinal diseases, diabetes mellitus type I and II * intake of supplements (vitamin D supplements, fish oil capsules, vitamins and minerals) 3 months before and during the study * relevant food allergies / intolerances * visit to the solarium (within 4 weeks before beginning of the study and during the study) * stay in the mountains / skiing (within 4 weeks before beginning of studies and during the study)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vitamin D status | change from baseline after 3 and 6 weeks | plasma levels of 25OHD2, 25OHD3 (nmol/l) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood glucose | change from baseline after 3 and 6 weeks | fasting blood glucose (mmol/l) |
| Insulin | change from baseline after 3 and 6 weeks | insulin (units/ml) |
| soluble Klotho (sKlotho) | change from baseline after 3 and 6 weeks | sKlotho is a component of the FGF23 system and is associated with longevity |
| Fibroblast growth factor 23 (FGF23) | change from baseline after 3 and 6 weeks | FGF23 is a regulator of vitamin D metabolism and also a risk factor for heart failure |
| Blood lipids | change from baseline after 3 and 6 weeks | total cholesterol, LDL cholesterol, HDL cholesterol, triacylglycerides (mmol/L) |
| Vitamin D forms 1 | change from baseline after 3 and 6 weeks | 1,25(OH)2D2 (nmol/l) |
| Vitamin D forms 2 | change from baseline after 3 and 6 weeks | 1,25(OH)2D3 (nmol/l) |
| Vitamin D forms 3 | change from baseline after 3 and 6 weeks | 24,25(OH)2D (nmol/l) |
| Vitamin D forms 4 | change from baseline after 3 and 6 weeks | 20(OH)D (nmol/l) |
| Fatty acid distribution (erythrocytes) | change from baseline after 3 and 6 weeks | fatty acid distribution in erythrocyte lipids (% fatty acid methyl ester) |
Countries
Germany
Outcome results
None listed