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Completed

NCT Number: NCT03499327

Human Intervention Study to Increase 25-hydroxyvitamin D Levels

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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Key information

Conditions

Vitamin D3 Deficiency

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Friedrich-Schiller-University

Jena, Thuringia, 07743, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Wheat germ oil (UV treated)

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)

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.

Primary outcomes

  1. Vitamin D status

    Time frame: change from baseline after 3 and 6 weeks

    plasma levels of 25OHD2, 25OHD3 (nmol/l)

Secondary outcomes

  1. Blood lipids

    Time frame: change from baseline after 3 and 6 weeks

    total cholesterol, LDL cholesterol, HDL cholesterol, triacylglycerides (mmol/L)

  2. Blood glucose

    Time frame: change from baseline after 3 and 6 weeks

    fasting blood glucose (mmol/l)

  3. Insulin

    Time frame: change from baseline after 3 and 6 weeks

    insulin (units/ml)

  4. soluble Klotho (sKlotho)

    Time frame: change from baseline after 3 and 6 weeks

    sKlotho is a component of the FGF23 system and is associated with longevity

  5. Fibroblast growth factor 23 (FGF23)

    Time frame: change from baseline after 3 and 6 weeks

    FGF23 is a regulator of vitamin D metabolism and also a risk factor for heart failure

  6. Fatty acid distribution (erythrocytes)

    Time frame: change from baseline after 3 and 6 weeks

    fatty acid distribution in erythrocyte lipids (% fatty acid methyl ester)

  7. Vitamin D forms 1

    Time frame: change from baseline after 3 and 6 weeks

    1,25(OH)2D2 (nmol/l)

  8. Vitamin D forms 2

    Time frame: change from baseline after 3 and 6 weeks

    1,25(OH)2D3 (nmol/l)

  9. Vitamin D forms 3

    Time frame: change from baseline after 3 and 6 weeks

    24,25(OH)2D (nmol/l)

  10. Vitamin D forms 4

    Time frame: change from baseline after 3 and 6 weeks

    20(OH)D (nmol/l)

Sponsors and collaborators

Lead sponsor

University of Jena

Other

Collaborators

  • Martin-Luther-Universität Halle-Wittenberg

Registry information

Official study 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)

Acronym: WeKo

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 17, 2018
Registry last updated
Feb 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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