Human Intervention Study to Increase 25-hydroxyvitamin D Levels
Condition: Vitamin D3 Deficiency
Study type: Interventional

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.
    

Intervention name(s): Wheat germ oil (UV treated); Wheat germ oil (untreated)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
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).
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: vitamin D; ergosterol; 7-dehydro-cholesterol; wheat germ oil