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.