Human Intervention Study to Increase 25-hydroxyvitamin D Levels
- Conditions
- Vitamin D3 Deficiency
- Interventions
- Dietary Supplement: Wheat germ oil (untreated)Dietary Supplement: Wheat germ oil (UV treated)
- Registration Number
- NCT03499327
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- healthy subjects
- plasma 25(OH) vitamin D < 50 nmol/l
- nutritional habits: western diet
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Wheat germ oil (untreated) Wheat germ oil (untreated) Wheat germ oil (untreated) Wheat germ oil (UV treated) Wheat germ oil (UV treated) Wheat germ oil (UV treated)
- Primary Outcome Measures
Name Time Method Vitamin D status change from baseline after 3 and 6 weeks plasma levels of 25OHD2, 25OHD3 (nmol/l)
- Secondary Outcome Measures
Name Time Method soluble Klotho (sKlotho) change from baseline after 3 and 6 weeks sKlotho is a component of the FGF23 system and is associated with longevity
Blood glucose change from baseline after 3 and 6 weeks fasting blood glucose (mmol/l)
Blood lipids change from baseline after 3 and 6 weeks total cholesterol, LDL cholesterol, HDL cholesterol, triacylglycerides (mmol/L)
Vitamin D forms 1 change from baseline after 3 and 6 weeks 1,25(OH)2D2 (nmol/l)
Insulin change from baseline after 3 and 6 weeks insulin (units/ml)
Fatty acid distribution (erythrocytes) change from baseline after 3 and 6 weeks fatty acid distribution in erythrocyte lipids (% fatty acid methyl ester)
Fibroblast growth factor 23 (FGF23) change from baseline after 3 and 6 weeks FGF23 is a regulator of vitamin D metabolism and also a risk factor for heart failure
Vitamin D forms 3 change from baseline after 3 and 6 weeks 24,25(OH)2D (nmol/l)
Vitamin D forms 4 change from baseline after 3 and 6 weeks 20(OH)D (nmol/l)
Vitamin D forms 2 change from baseline after 3 and 6 weeks 1,25(OH)2D3 (nmol/l)
Trial Locations
- Locations (1)
Friedrich-Schiller-University
🇩🇪Jena, Thuringia, Germany