Ignite Creation Date:
2024-05-06 @ 6:52 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05814874
Status:
RECRUITING
Last Update Posted:
2023-04-18
First Post:
2023-03-23
Brief Title:
Improvement of the Selenium Supply in a Vegan Diet by Different Selenium Sources
Sponsor:
University of Jena
Organization:
University of Jena
Study Overview
Official Title:
Human Intervention Study on the Improvement of the Selenium Supply in a Vegan Diet by Different Selenium Sources
Status:
RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SelVeg
Brief 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
Detailed 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 andor 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
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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None