Effects of a Healthy Vegan Diet Vs. Low Purine Diet, with or Without Amla Fruits (Emblica Officinalis) on Hyperuricemia and Other Cardiometabolic Risk Factors: a Randomized Two-by-two Factorial Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Uric acid
研究概览
简要总结
This is an intervention study aiming to test the effectiveness of a vegan diet, My Plate with low purine choices, and amla fruits on uric acid and other cardiometabolic risk factors in individuals with high serum uric acid levels.
详细描述
Ninety-two participants with hyperuricemia will be randomly assigned to one of these 4 diet interventions: (1) vegan, (2) vegan with amla fruits, (3) my plate-low purine, (4) my plate-low purine with amla fruits. During the 3 months intervention phase, participants will attend group lessons and individual nutrition counseling sessions to assist adherence to the diet. At baseline, end of 3 months, and 1 year, participants will be measured on uric acid and other cardiometabolic risk factors, and some nutritional markers. Amla fruits powder, and some foods encouraged in each dietary arm will be provided to enhance adherence during the 3 months intervention phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men with serum uric acid > 7mg/dL
- •Women with serum uric acid > 6mg/dL
- •Willing to make diet changes according to dietary interventions
排除标准
- •With cancer diagnosis
- •With diseases that require special dietary needs
- •On urate-lowering medication within 3 months
结局指标
主要结局
Uric acid
时间窗: 3 months
Serum uric acid
次要结局
- vitamin B12(3 months)
- homocysteine(3 months)
- vitamin D(3 months)
- Body mass index(3 months)
- holostranscobalamin(3 months)
- Glucose metabolism(3 months)
- Lipid profile(3 months)
研究者
Tina Hsueh-Ting Chiu
Assistant Professor
Fu Jen Catholic University