Human Intervention Study to Increase 25-hydroxyvitamin D Levels (WeKo)

University of Jena

Status: Completed

Conditions: Vitamin D3 Deficiency

Treatments: Dietary Supplement: Wheat germ oil (untreated); Dietary Supplement: Wheat germ oil (UV treated)

Study type: Interventional

Funder types: Other

Identifiers

NCT03499327

H5_18

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 3 patient groups, including a placebo group

Wheat germ oil (UV treated)

Active Comparator group

Description:

Wheat germ oil (UV treated)

Treatment:

Dietary Supplement: Wheat germ oil (UV treated)

Wheat germ oil (untreated)

Placebo Comparator group

Description:

Wheat germ oil (untreated)

Treatment:

Dietary Supplement: Wheat germ oil (untreated)

Control

No Intervention group

Description:

no study products