Human Intervention Study on the Improvement of the Selenium Supply in a Vegan Diet by Different Selenium Sources
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
干预措施: Placebo (Other)
vegan diet; placebo
干预措施: Placebo (Other)
meat-based diet; Brazil nut
干预措施: Brazil nut (Dietary Supplement)
meat-based diet; selenium supplement
干预措施: selenium supplement (Dietary Supplement)
vegan diet; Brazil nut
干预措施: Brazil nut (Dietary Supplement)
vegan diet; selenium supplement
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
Anna Kipp
Prof. Dr.
University of Jena
