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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05814874
Other study ID # 2023-2913-BO
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 2023
Est. completion date June 2023

Study information

Verified date April 2023
Source University of Jena
Contact Rebecca Simon
Phone 00493641949608
Email rebecca.simon@uni-jena.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

As vegans are among the individuals with the lowest serum selenium levels, the randomized controlled SelVeg study aims to address the question of whether Brazil nuts could be an adequate source of selenium for diets potentially low in selenium. For this purpose, we will investigate in individuals with a vegan or omnivorous dietary pattern how a daily selenium intervention in the form of a food (here Brazil nut butter) or an over-the-counter selenium supplement affects the selenium status.


Description:

The vegan diet is characterized by an exclusion of all animal foods and is associated with positive health effects. However, dietary restriction can lead to inadequate intake of both macro- and micronutrients. Selenium and zinc, among others are critical nutrients in a vegan diet. Brazil nuts represent a particularly selenium-rich plant food. In addition to selenium Brazil nuts have also relevant amounts of other trace elements, including zinc, iron and copper. Therefore, the aim of this study is to evaluate the effect of a daily selenium supplementation in the form of Brazil nut butter in comparison to a selenium supplement. As primary outcome, the serum selenium concentration and other serum biomarkers of the selenium status will be analyzed. Additionally, serum levels of other trace elements such as zinc will be quantified. Dietary questionnaires will provide information on dietary intake of nutrients (focus on dietary fiber, zinc and phytate intake) to identify potential factors influencing selenium bioavailability. The SelVeg study will enroll 90 healthy subjects with either a vegan (defined as exclusion of animal products) or omnivore (defined as weekly consumption of meat and/or sausage) dietary pattern. After categorizing in vegans or omnivores, participants are than randomized in one of the three intervention groups (placebo, Brazil nut or selenium supplement) and will receive 55 µg of additional daily selenium (as Brazil nut butter or tablet) or no additional selenium in case of placebo. The intervention period is 2 weeks.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date June 2023
Est. primary completion date June 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 30 Years
Eligibility Inclusion Criteria: - Apparently healthy participant - Adherence to one of following eating habit (vegan or omnivore) confirmed by food frequency protocol (5 d), lifestyle and nutrition questionnaires - Stable eating habit for at least 1 year before enrollment Exclusion Criteria: - Diet other than omnivore or vegan - Changing diet during the study period - Baseline serum selenium concentration > 150 µg/L - Acute or chronic disease (tumor, infection, other), gastrointestinal diseases, diabetes mellitus (type I, II), chronic renal disease, diseases of the parathyroids, diseases necessitating regular phlebotomies - Nut allergy - Pregnancy or lactation

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
selenium supplement
Selenium supplement containing 55 µg of sodium selenate
Brazil nut
Brazil nut butter; consumption corresponds to a selenium intake of 55 µg/d
Other:
Placebo
Placebo pill

Locations

Country Name City State
Germany Friedrich Schiller University Jena Jena Thuringia

Sponsors (1)

Lead Sponsor Collaborator
University of Jena

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Selenium status Changes in serum selenium concentration [µg/L] and selenoprotein-based biomarkers (SELENOP and GPX [U/L]) after intervention baseline and after 2 weeks
Secondary Trace element serum concentrations Change in serum concentration of trace elements (zinc, copper, manganese, iron, potassium and calcium [µg/L]) after intervention baseline and after 2 weeks
Secondary Anthropometric data body mass index [kg/m2] baseline and after 2 weeks
Secondary Mean macro- and micronutrient intake over 5 days baseline
Secondary Dietary zinc and phytate intake Zinc and Phytate Diet Score (= frequency index * quantity index * zinc or phytate content [mg]) 6 months
See also
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Recruiting NCT05451576 - Sodium Selenite Supplementation in Patients With Head and Neck Cancer N/A