The Effects of a 3-months Dietary Intervention With Folate Enhanced Foods on Folate Status in Healthy Egyptian Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Change in erythrocyte folate
研究概览
简要总结
This study evaluates the effects of folate-rich foods regarding improvement of folate status compared with folic acid supplement. A randomized, parallel intervention trial with two active groups (folate-rich foods or folic acid supplement) and one control group (apple juice - 0 µg/d folate) was executed over 12 weeks.
详细描述
Sixty-two women in reproductive age, apparently healthy, non-smokers, not consuming special diets (vegetarian), not pregnant, not planning conception or not lactating.
A randomized, controlled, parallel intervention trial with two active groups and one blinded control group was carried out for 12 weeks (March to June, 2013). The active food group (n = 21) consumed folate-rich foods (germinated canned faba beans, cookies, orange juice, providing additional 250 μg/d folate); the active folic acid supplement group consumed a supplement (n = 19, providing 500 μg/d folic acid); and the control group (n = 22) received apple juice containing no folate or folic acid) in addition to the freely chosen diet.
Fasted venous blood samples were collected at baseline, two months and three months for quantification of folate in plasma and erythrocytes and of homocysteine in plasma.
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
- 19 Years 至 32 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Normal biochemical range for:
- •Fasted plasma glucose
- •Iron status (haemoglobin, serum ferritin)
- •Liver status (aspartate transaminase, alanine transaminase, and γ-glutamyl transferase activities)
- •Lipid profile (triglycerides, LDL, HDL)
- •Folate status (plasma and erythrocyte folate)
- •Plasma total homocysteine (tHcy)
- •Vitamin B-12
排除标准
- •History of acute or chronic disease
- •Use of vitamin or mineral supplements or folic acid fortified foods (within the past one month)
- •A body mass index (BMI, in kg/m2) >18 and <30
- •Any medication interfering with folate metabolism (e.g., antiepileptic drugs, antibiotics, methotrexate, sulfasalazine, or anticonvulsants), smokers, consuming special diets (vegetarian), pregnancy, planned conception or lactation
结局指标
主要结局
Change in erythrocyte folate
时间窗: (0 and 12 weeks)
Assessment of erythrocyte folate at baseline, 8 and 12 weeks
Change in plasma folate
时间窗: (0 and 12 weeks)
Assessment of plasma folate at baseline, 8 and 12 weeks
次要结局
- Change in plasma total homocysteine((0 and 12 weeks))