Improvement of the Selenium Supply in a Vegan Diet by Different Selenium Sources

Selenium Clinical Trial

— SelVeg  

Official title:

Human Intervention Study on the Improvement of the Selenium Supply in a Vegan Diet by Different Selenium Sources

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05814874
• Other study ID #: 2023-2913-BO
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Selenium

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