Human Intervention Study to Increase 25-hydroxyvitamin D Levels

Vitamin D3 Deficiency Clinical Trial

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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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03499327
• Other study ID #: H5_18
• Status: Completed
• Phase: N/A
• Start date: March 5, 2018
• Est. completion date: April 30, 2018

Study information

• Verified date: February 2023
• Source: University of Jena
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 30, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Vitamin D3 Deficiency

Intervention

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.
• 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.

Locations

Country	Name	City	State
Germany	Friedrich-Schiller-University	Jena	Thuringia

Sponsors (2)

Lead Sponsor	Collaborator
University of Jena	Martin-Luther-Universität Halle-Wittenberg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vitamin D status	plasma levels of 25OHD2, 25OHD3 (nmol/l)	change from baseline after 3 and 6 weeks
Secondary	Blood lipids	total cholesterol, LDL cholesterol, HDL cholesterol, triacylglycerides (mmol/L)	change from baseline after 3 and 6 weeks
Secondary	Blood glucose	fasting blood glucose (mmol/l)	change from baseline after 3 and 6 weeks
Secondary	Insulin	insulin (units/ml)	change from baseline after 3 and 6 weeks
Secondary	soluble Klotho (sKlotho)	sKlotho is a component of the FGF23 system and is associated with longevity	change from baseline after 3 and 6 weeks
Secondary	Fibroblast growth factor 23 (FGF23)	FGF23 is a regulator of vitamin D metabolism and also a risk factor for heart failure	change from baseline after 3 and 6 weeks
Secondary	Fatty acid distribution (erythrocytes)	fatty acid distribution in erythrocyte lipids (% fatty acid methyl ester)	change from baseline after 3 and 6 weeks
Secondary	Vitamin D forms 1	1,25(OH)2D2 (nmol/l)	change from baseline after 3 and 6 weeks
Secondary	Vitamin D forms 2	1,25(OH)2D3 (nmol/l)	change from baseline after 3 and 6 weeks
Secondary	Vitamin D forms 3	24,25(OH)2D (nmol/l)	change from baseline after 3 and 6 weeks
Secondary	Vitamin D forms 4	20(OH)D (nmol/l)	change from baseline after 3 and 6 weeks

External Links

•   Study results