NCT05814874

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2023

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 23, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

April 18, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2023

Completed
Last Updated

March 21, 2025

Status Verified

January 1, 2024

Enrollment Period

3 months

First QC Date

March 23, 2023

Last Update Submit

March 18, 2025

Conditions

Diet, VeganSelenium

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Trace element serum concentrations

    baseline and after 2 weeks

  • Anthropometric data

    baseline and after 2 weeks

  • Mean macro- and micronutrient intake over 5 days

    baseline

  • Dietary zinc and phytate intake

    6 months

Study Arms (6)

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

Interventions

selenium supplementDIETARY_SUPPLEMENT

Selenium supplement containing 55 µg of sodium selenate

meat-based diet; selenium supplementvegan diet; selenium supplement
Brazil nutDIETARY_SUPPLEMENT

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

meat-based diet; Brazil nutvegan diet; Brazil nut
PlaceboOTHER

Placebo pill

meat-based diet; placebovegan diet; placebo

Eligibility Criteria

Age18 Years - 35 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsfemale (before menopause) and male gender (50% each)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Friedrich Schiller University Jena

Jena, Thuringia, 07743, Germany

Location

Related Publications (1)

  • 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.

    PMID: 39891729DERIVED

MeSH Terms

Interventions

2S albumin, brazil nut

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 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)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

March 23, 2023

First Posted

April 18, 2023

Study Start

March 20, 2023

Primary Completion

June 5, 2023

Study Completion

June 5, 2023

Last Updated

March 21, 2025

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will share

Open access publications

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
end of 2023

Locations

DE(1)