Dietary Fiber Intervention in Hutterite Population of South Dakota With and Without Signs of Metabolic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Changes in metabolic syndrome risk components
研究概览
简要总结
Metabolic syndrome is a condition characterized by excess body weight, large waist circumference, high cholesterol and glucose in the blood, and hypertension. People with metabolic syndrome are at increased risk for heart diseases. Research shows benefits of regular fiber intake in metabolic syndrome. However, due to altered taste and texture of the high fiber foods, long term intake of fiber is a challenge for metabolic syndrome patients. This study is designed to find if blinded-substitution of regular wheat flour in domestic kitchen with wheat flour enriched by an adaptable type of fiber (resistant starch-4), minimizes metabolic syndrome symptoms. this special type of fiber is also obtained from wheat.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any individual aged 18-80 years
排除标准
- •Lactating
- •Requires special diets or dietary regimens
- •On long term antibiotic therapy
- •Diagnosed with gastrointestinal diseases (Irritable Bowel syndrome, Crohn's disease or Colitis)
- •Immune compromised
- •Have cancer
研究组 & 干预措施
Community-1
Received control flour first and then Resistant starch type 4 (RS4) flour
干预措施: RS4 enriched flour (Other)
Community-1
Received control flour first and then Resistant starch type 4 (RS4) flour
干预措施: Control flour (Other)
Community-2
Received RS4 flour first and then control flour
干预措施: RS4 enriched flour (Other)
Community-2
Received RS4 flour first and then control flour
干预措施: Control flour (Other)
结局指标
主要结局
Changes in metabolic syndrome risk components
时间窗: 26 weeks
次要结局
- Changes in anthropometric outcomes(26 weeks)
- Changes in blood glucose indices(26 weeks)
- Changes in blood lipid profile(26 weeks)
研究者
Moul Dey
Associate Professor
South Dakota State University
