Diet, VeganSelVegNCT05814874
Improvement of the Selenium Supply in a Vegan Diet by Different Selenium Sources
A study testing selenium supplement and Brazil nut in people with Diet, Vegan and Selenium, run by University of Jena at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet, Vegan, Selenium
- What is being tested?
- selenium supplement and Brazil nut
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteGermany
- Study dates
- 20 Mar 2023to 5 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Human Intervention Study on the 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.
Read the 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 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.
- Conditions
- Diet, Vegan, Selenium
- Being tested
- selenium supplement, Brazil nut, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
selenium supplementDietary supplement
Selenium supplement containing 55 µg of sodium selenate
Brazil nutDietary supplement
Brazil nut butter; consumption corresponds to a selenium intake of 55 µg/d
PlaceboOther
Placebo pill
| Study group | Role | What they receive |
|---|---|---|
| meat-based diet; placebo | Placebo comparator | Not described Receives: Other: Placebo |
| meat-based diet; selenium supplement | Active comparator | Not described Receives: Dietary Supplement: selenium supplement |
| meat-based diet; Brazil nut | Active comparator | Not described Receives: Dietary Supplement: Brazil nut |
| vegan diet; placebo | Placebo comparator | Not described Receives: Other: Placebo |
| vegan diet; selenium supplement | Active comparator | Not described Receives: Dietary Supplement: selenium supplement |
| vegan diet; Brazil nut | Active comparator | Not described Receives: Dietary Supplement: Brazil nut |
What is being measured
The primary outcome is the main question the study is designed to answer.
Selenium status
Changes in serum selenium concentration [µg/L] and selenoprotein-based biomarkers (SELENOP and GPX [U/L]) after intervention
Measured: baseline and after 2 weeks
Secondary outcomes (4)
Trace element serum concentrations
Change in serum concentration of trace elements (zinc, copper, manganese, iron, potassium and calcium [µg/L]) after intervention
Measured: baseline and after 2 weeks
Anthropometric data
body mass index [kg/m2]
Measured: baseline and after 2 weeks
Mean macro- and micronutrient intake over 5 days
Measured: baseline
Dietary zinc and phytate intake
Zinc and Phytate Diet Score (= frequency index * quantity index * zinc or phytate content [mg])
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start20 Mar 2023
- Primary completion5 Jun 2023
- Study completion5 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diet, VeganStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- non-blinded randomized controlled trial Parallel group design (2 groups): vegan (exclusion of animal products) vs. omnivore (weekly consumption of meat and/or sausage), stable dietary habit since at least one year, 3 intervention groups (placebo, Brazil nut or selenium supplement)
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Kipp, University of Jena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05814874
- Sponsor's protocol ID
- 2023-2913-BO
- Acronym
- SelVeg
- Status last verified
- Jan 2024
- First submitted
- 23 Mar 2023
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Open access publications
Publications
Simon R, Lossow K, Pellowski D, Kipp K, Achatz M, Klasen N, Schwerdtle T, Dawczynski C, Kipp AP. Improving the selenium supply of vegans and omnivores with Brazil nut butter compared to a dietary supplement in a randomized controlled trial. Eur J Nutr. 2025 Feb 1;64(2):74. doi: 10.1007/s00394-025-03587-z.
PubMed 39891729
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Intervention Study on the Improvement of the Selenium Supply in a Vegan Diet by Different Selenium Sources
- ClinicalTrials.gov ID
- NCT05814874
- Acronym / sponsor ID
- SelVeg / 2023-2913-BO
- Conditions
- Diet, Vegan, Selenium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of JenaUniversity, hospital or other
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 5 Jun 2023 (actual)
- Study completion
- 5 Jun 2023 (actual)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- non-blinded randomized controlled trial Parallel group design (2 groups): vegan (exclusion of animal products) vs. omnivore (weekly consumption of meat and/or sausage), stable dietary habit since at least one year, 3 intervention groups (placebo, Brazil nut or selenium supplement)
| Arm | Type | Receives |
|---|---|---|
| meat-based diet; placebo | Placebo comparator | Other: Placebo |
| meat-based diet; selenium supplement | Active comparator | Dietary Supplement: selenium supplement |
| meat-based diet; Brazil nut | Active comparator | Dietary Supplement: Brazil nut |
| vegan diet; placebo | Placebo comparator | Other: Placebo |
| vegan diet; selenium supplement | Active comparator | Dietary Supplement: selenium supplement |
| vegan diet; Brazil nut | Active comparator | Dietary Supplement: Brazil nut |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| selenium supplementSelenium supplement containing 55 µg of sodium selenate | Dietary supplement | meat-based diet; selenium supplement, vegan diet; selenium supplement |
| Brazil nutBrazil nut butter; consumption corresponds to a selenium intake of 55 µg/d | Dietary supplement | meat-based diet; Brazil nut, vegan diet; Brazil nut |
| PlaceboPlacebo pill | Other | meat-based diet; placebo, vegan diet; placebo |
Primary outcome
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
4 secondary outcomes
Trace element serum concentrations
Time frame: baseline and after 2 weeks
Anthropometric data
Time frame: baseline and after 2 weeks
Mean macro- and micronutrient intake over 5 days
Time frame: baseline
Dietary zinc and phytate intake
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Derived from this study: PubMed 39891729Simon R, Lossow K, Pellowski D, Kipp K, Achatz M, Klasen N, Schwerdtle T, Dawczynski C, Kipp AP. Improving the selenium supply of vegans and omnivores with Brazil nut butter compared to a dietary supplement in a randomized controlled trial. Eur J Nutr. 2025 Feb 1;64(2):74. doi: 10.1007/s00394-025-03587-z.
- Individual participant dataSharing planned: Yes. Open access publications
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing selenium supplement and Brazil nut in people with Diet, Vegan and Selenium, run by University of Jena at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Selenium status (time frame: baseline and after 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05814874, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.