An interventional study of Wheat germ oil (UV treated) and Wheat germ oil (untreated) in Vitamin D3 Deficiency, sponsored by University of Jena. Completed at 1 site in Germany. Open to participants aged 20 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-22.
Sponsored by University of Jena · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Wheat germ oil (UV treated)
Dietary Supplement: Wheat germ oil (UV treated)
Wheat germ oil (untreated)
Dietary Supplement: Wheat germ oil (untreated)
no study products
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.
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.
Vitamin D status
plasma levels of 25OHD2, 25OHD3 (nmol/l)
Time frame: change from baseline after 3 and 6 weeks
Blood lipids
total cholesterol, LDL cholesterol, HDL cholesterol, triacylglycerides (mmol/L)
Time frame: change from baseline after 3 and 6 weeks
Blood glucose
fasting blood glucose (mmol/l)
Time frame: change from baseline after 3 and 6 weeks
Insulin
insulin (units/ml)
Time frame: change from baseline after 3 and 6 weeks
soluble Klotho (sKlotho)
sKlotho is a component of the FGF23 system and is associated with longevity
Time frame: 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
Time frame: change from baseline after 3 and 6 weeks
Fatty acid distribution (erythrocytes)
fatty acid distribution in erythrocyte lipids (% fatty acid methyl ester)
Time frame: change from baseline after 3 and 6 weeks
Vitamin D forms 1
1,25(OH)2D2 (nmol/l)
Time frame: change from baseline after 3 and 6 weeks
Vitamin D forms 2
1,25(OH)2D3 (nmol/l)
Time frame: change from baseline after 3 and 6 weeks
Vitamin D forms 3
24,25(OH)2D (nmol/l)
Time frame: change from baseline after 3 and 6 weeks
Vitamin D forms 4
20(OH)D (nmol/l)
Time frame: change from baseline after 3 and 6 weeks
Plan to share: No
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University of Jena