Human Intervention Study to Increase 25-hydroxyvitamin D Levels

Study Overview
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Brief Summary
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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
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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.

Official Title
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Human Intervention Study to Increase 25-hydroxyvitamin D Levels by Regular Consumption of Wheat Germ Oil (UV-treated) vs. Wheat Germ Oil Untreated (Control)

Conditions
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Vitamin D3 Deficiency

Intervention / Treatment
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* Dietary Supplement: Wheat germ oil (UV treated)
* Dietary Supplement: Wheat germ oil (untreated)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Wheat germ oil (UV treated)<br>Wheat germ oil (UV treated) | Dietary Supplement: Wheat germ oil (UV treated)<br>* 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.<br>|
| Placebo Comparator: Wheat germ oil (untreated)<br>Wheat germ oil (untreated) | Dietary Supplement: Wheat germ oil (untreated)<br>* 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.<br>|
| No Intervention: Control<br>no study products | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vitamin D status | plasma levels of 25OHD2, 25OHD3 (nmol/l) | change from baseline after 3 and 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood lipids | total cholesterol, LDL cholesterol, HDL cholesterol, triacylglycerides (mmol/L) | change from baseline after 3 and 6 weeks | 
| Blood glucose | fasting blood glucose (mmol/l) | change from baseline after 3 and 6 weeks | 
| Insulin | insulin (units/ml) | change from baseline after 3 and 6 weeks | 
| soluble Klotho (sKlotho) | sKlotho is a component of the FGF23 system and is associated with longevity | change from baseline after 3 and 6 weeks | 
| Fibroblast growth factor 23 (FGF23) | FGF23 is a regulator of vitamin D metabolism and also a risk factor for heart failure | change from baseline after 3 and 6 weeks | 
| Fatty acid distribution (erythrocytes) | fatty acid distribution in erythrocyte lipids (% fatty acid methyl ester) | change from baseline after 3 and 6 weeks | 
| Vitamin D forms 1 | 1,25(OH)2D2 (nmol/l) | change from baseline after 3 and 6 weeks | 
| Vitamin D forms 2 | 1,25(OH)2D3 (nmol/l) | change from baseline after 3 and 6 weeks | 
| Vitamin D forms 3 | 24,25(OH)2D (nmol/l) | change from baseline after 3 and 6 weeks | 
| Vitamin D forms 4 | 20(OH)D (nmol/l) | change from baseline after 3 and 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vitamin D, ergosterol, 7-dehydro-cholesterol, wheat germ oil