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临床试验/NCT01887964
NCT01887964已完成不适用

Dietary Fiber Intervention in Hutterite Population of South Dakota With and Without Signs of Metabolic Syndrome

South Dakota State University1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2012年3月1日最近更新:
适应症
干预措施

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

Other

Received control flour first and then Resistant starch type 4 (RS4) flour

干预措施: RS4 enriched flour (Other)

Community-1

Other

Received control flour first and then Resistant starch type 4 (RS4) flour

干预措施: Control flour (Other)

Community-2

Other

Received RS4 flour first and then control flour

干预措施: RS4 enriched flour (Other)

Community-2

Other

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Moul Dey

Associate Professor

South Dakota State University

研究点 (1)

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