To Critically Investigate and Evaluate Supplementary Vitamin B12 Effects on Elevated Homocysteine Levels of Vegetarians, Who May Have a Resultant Susceptibility to Hyperhomocysteinemia Related Diseases.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Reduction of plasma total homocysteine of vegetarians
研究概览
简要总结
Vegetarians are known to be deficient in vitamin B12, due to a lack or absence of dietary animal produce, which can elevate homocysteine. There is strong evidence indicating that elevated plasma total homocysteine (tHcy) is a contributor to chronic conditions, such as primary cardiovascular disease (CVD). The study hypothesis is: There will be a significant decrease in plasma tHcy of vegetarians following the intervention by supplementary vitamin B12 (of the methylcobalamin type) and this will lead to a reduction of the risk of CVD.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Having a plasma tHcy >10 micromol/L
- •Not suffering from conditions as described in
排除标准
- •Vegetarian for at least one year.
- •Not participating in a weight reducing diet.
- •Not consuming regularly vitamin B12 supplements.
- •Give written consent to participate in clinical trial and be fluent in English language.
- •Exclusion Criteria:
- •Having a plasma tHcy less or equal to 10 micromol/L.
- •Suffering from pernicious anemia or other vitamin B12 deficiency disease.
- •Undergone bowel surgery or suffer from gastrointestinal disease.
- •Pregnant, lactating or trying to conceive.
- •Alcohol intake regularly greater than official recommended daily units (i.e. 2 units female, 3 units male).
- •Consume large amounts of caffeine (regular consumption of >4 cups of strong tea or coffee per day).
- •Use of medications known to influence nutritional status.
- •Have genetic metabolic disease.
- •Suffer from renal failure, diabetes, thyroid disease, cardiovascular disease, dementia or cancer.
- •Have a known blood-borne infection (e.g. Hepatitis or HIV).
研究组 & 干预措施
Inactive lozenge
Inactive lozenge containing 2mg sucrose dissolved in the mouth taken after a meal every other day for 16 weeks
干预措施: Inactive lozenge (Dietary Supplement)
Methylcobalamin
Methylcobalamin 1mg lozenge dissolved in the mouth following a meal taken every other day for 16 weeks.
干预措施: Inactive lozenge (Dietary Supplement)
Methylcobalamin
Methylcobalamin 1mg lozenge dissolved in the mouth following a meal taken every other day for 16 weeks.
干预措施: Methylcobalamin (Dietary Supplement)
Inactive lozenge
Inactive lozenge containing 2mg sucrose dissolved in the mouth taken after a meal every other day for 16 weeks
干预措施: Methylcobalamin (Dietary Supplement)
结局指标
主要结局
Reduction of plasma total homocysteine of vegetarians
时间窗: 16 weeks per participant
次要结局
- Improvement in systolic and diastolic blood pressure(16 weeks per participant)
研究者
Derek Obersby
PhD Student
University of West London