Clinical trial NCT03499327: Human Intervention Study to Increase 25-hydroxyvitamin D Levels
Official title: Human Intervention Study to Increase 25-hydroxyvitamin D Levels by Regular Consumption of Wheat Germ Oil (UV-treated) vs. Wheat Germ Oil Untreated (Control)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D3 Deficiency
Keywords: vitamin D
ergosterol
7-dehydro-cholesterol
wheat germ oil
Lead sponsor: University of Jena
Sponsor class: OTHER
Collaborators: name: Martin-Luther-Universität Halle-Wittenberg
First posted: 2018-04-17
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Vitamin D status
timeFrame: change from baseline after 3 and 6 weeks
Secondary outcomes:
measure: Blood lipids
timeFrame: change from baseline after 3 and 6 weeks
measure: Blood glucose
timeFrame: change from baseline after 3 and 6 weeks
measure: Insulin
timeFrame: change from baseline after 3 and 6 weeks
measure: soluble Klotho (sKlotho)
timeFrame: change from baseline after 3 and 6 weeks
measure: Fibroblast growth factor 23 (FGF23)
timeFrame: change from baseline after 3 and 6 weeks
measure: Fatty acid distribution (erythrocytes)
timeFrame: change from baseline after 3 and 6 weeks
measure: Vitamin D forms 1
timeFrame: change from baseline after 3 and 6 weeks
measure: Vitamin D forms 2
timeFrame: change from baseline after 3 and 6 weeks
measure: Vitamin D forms 3
timeFrame: change from baseline after 3 and 6 weeks
measure: Vitamin D forms 4
timeFrame: change from baseline after 3 and 6 weeks
Other outcomes:
Locations:
city: Jena
country: Germany
facility: Friedrich-Schiller-University
state: Thuringia
Study officials:
References:
citation: Bailer AC, Philipp S, Staudt S, Weidauer T, Kiehntopf M, Lorkowski S, Stangl GI, Dawczynski C. UVB-exposed wheat germ oil increases serum 25-hydroxyvitamin D2 without improving overall vitamin D status: a randomized controlled trial. Eur J Nutr. 2022 Aug;61(5):2571-2583. doi: 10.1007/s00394-022-02827-w. Epub 2022 Feb 27.