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临床试验/NCT05814874
NCT05814874已完成不适用

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

University of Jena1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年3月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
试验地点
1
主要终点
Selenium status

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

meat-based diet; placebo

Placebo Comparator

干预措施: Placebo (Other)

vegan diet; placebo

Placebo Comparator

干预措施: Placebo (Other)

meat-based diet; Brazil nut

Active Comparator

干预措施: Brazil nut (Dietary Supplement)

meat-based diet; selenium supplement

Active Comparator

干预措施: selenium supplement (Dietary Supplement)

vegan diet; Brazil nut

Active Comparator

干预措施: Brazil nut (Dietary Supplement)

vegan diet; selenium supplement

Active Comparator

干预措施: selenium supplement (Dietary Supplement)

结局指标

主要结局

Selenium status

时间窗: baseline and after 2 weeks

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

次要结局

  • 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)

研究者

发起方
University of Jena
申办方类型
Other
责任方
Principal Investigator
主要研究者

Anna Kipp

Prof. Dr.

University of Jena

研究点 (1)

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