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

Sponsor

University of Jena (Other)

Overall Status

Recruiting

CT.gov ID

NCT05814874

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

44.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diet, Vegan Selenium	Dietary Supplement: selenium supplement Dietary Supplement: Brazil nut Other: Placebo	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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)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)

Primary Purpose:

Basic Science

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: meat-based diet; placebo	Other: Placebo Placebo pill
Active Comparator: meat-based diet; selenium supplement	Dietary Supplement: selenium supplement Selenium supplement containing 55 µg of sodium selenate
Active Comparator: meat-based diet; Brazil nut	Dietary Supplement: Brazil nut Brazil nut butter; consumption corresponds to a selenium intake of 55 µg/d
Placebo Comparator: vegan diet; placebo	Other: Placebo Placebo pill
Active Comparator: vegan diet; selenium supplement	Dietary Supplement: selenium supplement Selenium supplement containing 55 µg of sodium selenate
Active Comparator: vegan diet; Brazil nut	Dietary Supplement: Brazil nut Brazil nut butter; consumption corresponds to a selenium intake of 55 µg/d

Outcome Measures

Primary Outcome Measures

Selenium status [baseline and after 2 weeks]
Changes in serum selenium concentration [µg/L] and selenoprotein-based biomarkers (SELENOP and GPX [U/L]) after intervention

Secondary Outcome Measures

Trace element serum concentrations [baseline and after 2 weeks]
Change in serum concentration of trace elements (zinc, copper, manganese, iron, potassium and calcium [µg/L]) after intervention
Anthropometric data [baseline and after 2 weeks]
body mass index [kg/m2]
Mean macro- and micronutrient intake over 5 days [baseline]
Dietary zinc and phytate intake [6 months]
Zinc and Phytate Diet Score (= frequency index * quantity index * zinc or phytate content [mg])

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 30 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Friedrich Schiller University Jena	Jena	Thuringia	Germany	07743

Sponsors and Collaborators

University of Jena

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Anna Kipp, Prof. Dr., University of Jena

ClinicalTrials.gov Identifier:

NCT05814874

Other Study ID Numbers:

2023-2913-BO

First Posted:

Apr 18, 2023

Last Update Posted:

Apr 18, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Selenium

Study Results

No Results Posted as of Apr 18, 2023