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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03499327
Recruitment Status : Completed
First Posted : April 17, 2018
Last Update Posted : May 8, 2018
Sponsor:
Collaborator:
Martin-Luther-Universität Halle-Wittenberg
Information provided by (Responsible Party):
Christine Dawczynski,PhD, University of Jena

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.

Condition or disease Intervention/treatment Phase
Vitamin D3 Deficiency Dietary Supplement: Wheat germ oil (UV treated) Dietary Supplement: Wheat germ oil (untreated) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
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)
Masking Description: 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).
Primary Purpose: Treatment
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)
Actual Study Start Date : March 5, 2018
Actual Primary Completion Date : April 30, 2018
Actual Study Completion Date : April 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Calcifediol

Arm Intervention/treatment
Active Comparator: Wheat germ oil (UV treated)
Wheat germ oil (UV treated)
Dietary Supplement: 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.


Placebo Comparator: Wheat germ oil (untreated)
Wheat germ oil (untreated)
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.


No Intervention: Control
no study products



Primary Outcome Measures :
  1. Vitamin D status [ Time Frame: change from baseline after 3 and 6 weeks ]
    plasma levels of 25OHD2, 25OHD3 (nmol/l)


Secondary Outcome Measures :
  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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03499327


Locations
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Germany
Friedrich-Schiller-University
Jena, Thuringia, Germany, 07743
Sponsors and Collaborators
University of Jena
Martin-Luther-Universität Halle-Wittenberg

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Responsible Party: Christine Dawczynski,PhD, Head of the Junior Research Group Nutritional Concepts, University of Jena
ClinicalTrials.gov Identifier: NCT03499327    
Other Study ID Numbers: H5_18
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Christine Dawczynski,PhD, University of Jena:
vitamin D
ergosterol
7-dehydro-cholesterol
wheat germ oil
Additional relevant MeSH terms:
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Hydroxycholecalciferols
Calcifediol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents