Human Intervention Study to Increase 25-hydroxyvitamin D Levels

NCT03499327 | Completed

• 1 other identifier: H5_18
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin D3 Deficiency

Keywords

vitamin D; ergosterol; 7-dehydro-cholesterol; wheat germ oil

Outcome Measures

Primary Outcomes (1)

• Vitamin D status

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

  change from baseline after 3 and 6 weeks

Secondary Outcomes (10)

• Blood lipids

  change from baseline after 3 and 6 weeks

• Blood glucose

  change from baseline after 3 and 6 weeks

• Insulin

  change from baseline after 3 and 6 weeks

• soluble Klotho (sKlotho)

  change from baseline after 3 and 6 weeks

• Fibroblast growth factor 23 (FGF23)

  change from baseline after 3 and 6 weeks

Study Arms (3)

Wheat germ oil (UV treated)

ACTIVE COMPARATOR

Wheat germ oil (UV treated)

Dietary Supplement: Wheat germ oil (UV treated)

Wheat germ oil (untreated)

PLACEBO COMPARATOR

Wheat germ oil (untreated)

Dietary Supplement: Wheat germ oil (untreated)

Control

NO INTERVENTION

no study products

Interventions

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 (UV treated)

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.

Wheat germ oil (untreated)

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy subjects
• plasma 25(OH) vitamin D \< 50 nmol/l
• nutritional habits: western diet

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Jena: lead
• Martin-Luther-Universität Halle-Wittenberg: collaborator

Study Sites (1)

Friedrich-Schiller-University

Jena, Thuringia, 07743, Germany

Location

Related Publications (1)

• Bailer AC, Philipp S, Staudt S, Weidauer T, Kiehntopf M, Lorkowski S, Stangl GI, Dawczynski C. UVB-exposed wheat germ oil increases serum 25-hydroxyvitamin D2 without improving overall vitamin D status: a randomized controlled trial. Eur J Nutr. 2022 Aug;61(5):2571-2583. doi: 10.1007/s00394-022-02827-w. Epub 2022 Feb 27.

  PMID: 35220442 DERIVED

Related Links

• Study results

MeSH Terms

Interventions

wheat germ oil

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Junior Research Group Nutritional Concepts

Model Details: 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).

Study Record Dates

• First Submitted: March 29, 2018
• First Posted: April 17, 2018
• Study Start: March 5, 2018
• Primary Completion: April 30, 2018
• Study Completion: April 30, 2018
• Last Updated: February 22, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)