The Bioavailability of Vitamin B12 From Nori in Vegetarians: a Dose Response Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in holotranscobalamin in 4 weeks
研究概览
简要总结
This is an intervention study aiming to understand the bioavailability of vitamin B12 from nori for vegetarians.
详细描述
Thirty vegetarian participants will be randomly assigned to one of three intervention arms: (1) 5g of nori (4 sheets, containing 2.4μg vitamin B12), (2) 8g nori (7 sheets, containing 4μg vitamin B12), (3) control group (no nori). At baseline and end of 4 weeks, participants will be measured on serum vitamin B12, methylmalonic acid, holotranscobalamin, homocysteine and folate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Vegetarians (including vegan, ovo-vegetarian, lacto-vegetarian, lacto-ovo vegetarian)
- •Duration of the vegetarian diet: at least 1 year
- •Aged 20-60 years old
- •Have not taken vitamin B12 or folate supplement within 1 year
- •Willing to adhere to study intervention and be tested for vitamin B12 related biomarkers.
- •Familiar with LINE application on smartphone
排除标准
- •Any disease or surgery that affects the vitamin B12 status (Pernicious anemia, Gastrointestinal disease and surgery, Pancreatic diseases, Chronic kidney disease)
- •Hyperthyroidism
- •Previous adverse reaction to nori
- •Have taken antacid or metformin in the past 1 week
- •Alcoholic and not willing to abstinence from alcoholic beverages
结局指标
主要结局
Change in holotranscobalamin in 4 weeks
时间窗: 4 weeks (Week 4 - Baseline)
Assessing the change in serum holotranscobalamin after consuming varying doses of nori
Change in methylmalonic acid in 4 weeks
时间窗: 4 weeks (Week 4 - Baseline)
Assessing the change in serum methylmalonic acid after consuming varying doses of nori
次要结局
- Change in serum vitamin B12 concentration in 4 weeks(4 weeks (Week 4 - Baseline))
- Change in homocysteine in 4 weeks(4 weeks (Week 4 - Baseline))
研究者
Tina Hsueh-Ting Chiu
Associate Professor
Fu Jen Catholic University