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Completed

NCT Number: NCT05814874

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

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.

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Key information

Conditions

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Friedrich Schiller University Jena

Jena, Thuringia, 07743, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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, chronic renal disease, diseases of the parathyroids, diseases necessitating regular phlebotomies
  • Nut allergy
  • Pregnancy or lactation

Treatment and study plan

selenium supplement

Dietary Supplement

Selenium supplement containing 55 µg of sodium selenate

Brazil Nut

Dietary Supplement

Brazil nut butter; consumption corresponds to a selenium intake of 55 µg/d

Placebo

Other

Placebo pill

Primary outcomes

  1. Selenium status

    Time frame: baseline and after 2 weeks

    Changes in serum selenium concentration [µg/L] and selenoprotein-based biomarkers (SELENOP and GPX [U/L]) after intervention

Secondary outcomes

  1. Trace element serum concentrations

    Time frame: baseline and after 2 weeks

    Change in serum concentration of trace elements (zinc, copper, manganese, iron, potassium and calcium [µg/L]) after intervention

  2. Anthropometric data

    Time frame: baseline and after 2 weeks

    body mass index [kg/m2]

  3. Mean macro- and micronutrient intake over 5 days

    Time frame: baseline

  4. Dietary zinc and phytate intake

    Time frame: 6 months

    Zinc and Phytate Diet Score (= frequency index * quantity index * zinc or phytate content [mg])

Sponsors and collaborators

Lead sponsor

University of Jena

Other

Registry information

Official study title

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

Acronym: SelVeg

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 18, 2023
Registry last updated
Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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