Human Intervention Study to Increase 25-hydroxyvitamin D Levels

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-05

Study Completion Date

2018-04-30

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.

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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.

Conditions

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Vitamin D3 Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

The wheat germ oil 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).

Study Groups

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Wheat germ oil (UV treated)

Group Type ACTIVE_COMPARATOR

Wheat germ oil (UV treated)

Intervention Type DIETARY_SUPPLEMENT

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.

Wheat germ oil (untreated)

Group Type PLACEBO_COMPARATOR

Wheat germ oil (untreated)

Intervention Type DIETARY_SUPPLEMENT

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.

Control

no study products

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Wheat germ oil (UV treated)

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.

Intervention Type DIETARY_SUPPLEMENT

Wheat germ oil (untreated)

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.

Intervention Type DIETARY_SUPPLEMENT

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)

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes