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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

Tracking Information
First Submitted Date  ICMJE March 29, 2018
First Posted Date  ICMJE April 17, 2018
Last Update Posted Date May 8, 2018
Actual Study Start Date  ICMJE March 5, 2018
Actual Primary Completion Date April 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 13, 2018)
Vitamin D status [ Time Frame: change from baseline after 3 and 6 weeks ]
plasma levels of 25OHD2, 25OHD3 (nmol/l)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 13, 2018)
  • Blood lipids [ Time Frame: change from baseline after 3 and 6 weeks ]
    total cholesterol, LDL cholesterol, HDL cholesterol, triacylglycerides (mmol/L)
  • Blood glucose [ Time Frame: change from baseline after 3 and 6 weeks ]
    fasting blood glucose (mmol/l)
  • Insulin [ Time Frame: change from baseline after 3 and 6 weeks ]
    insulin (units/ml)
  • 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
  • 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
  • Fatty acid distribution (erythrocytes) [ Time Frame: change from baseline after 3 and 6 weeks ]
    fatty acid distribution in erythrocyte lipids (% fatty acid methyl ester)
  • Vitamin D forms 1 [ Time Frame: change from baseline after 3 and 6 weeks ]
    1,25(OH)2D2 (nmol/l)
  • Vitamin D forms 2 [ Time Frame: change from baseline after 3 and 6 weeks ]
    1,25(OH)2D3 (nmol/l)
  • Vitamin D forms 3 [ Time Frame: change from baseline after 3 and 6 weeks ]
    24,25(OH)2D (nmol/l)
  • Vitamin D forms 4 [ Time Frame: change from baseline after 3 and 6 weeks ]
    20(OH)D (nmol/l)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Human Intervention Study to Increase 25-hydroxyvitamin D Levels
Official Title  ICMJE Human Intervention Study to Increase 25-hydroxyvitamin D Levels by Regular Consumption of Wheat Germ Oil (UV-treated) vs. Wheat Germ Oil Untreated (Control)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Vitamin D3 Deficiency
Intervention  ICMJE
  • 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.

  • 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.

Study Arms  ICMJE
  • Active Comparator: Wheat germ oil (UV treated)
    Wheat germ oil (UV treated)
    Intervention: Dietary Supplement: Wheat germ oil (UV treated)
  • Placebo Comparator: Wheat germ oil (untreated)
    Wheat germ oil (untreated)
    Intervention: Dietary Supplement: Wheat germ oil (untreated)
  • No Intervention: Control
    no study products
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 13, 2018)
50
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 30, 2018
Actual Primary Completion Date April 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03499327
Other Study ID Numbers  ICMJE H5_18
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Christine Dawczynski,PhD, University of Jena
Study Sponsor  ICMJE University of Jena
Collaborators  ICMJE Martin-Luther-Universität Halle-Wittenberg
Investigators  ICMJE Not Provided
PRS Account University of Jena
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP