Effect of Resistant Starch (Type-4) on Metabolic Syndrome

Study Overview
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Brief Summary
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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.

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

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Other: RS4 enriched flour
* Other: Control flour


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Any individual aged 18-80 years Exclusion Criteria: Pregnant 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Community-1<br>Received control flour first and then Resistant starch type 4 (RS4) flour | Other: RS4 enriched flour<br>* Wheat flour with 30% resistant starch (type-4)<br>Other: Control flour<br>* Wheat flour without resistant starch (type-4)<br>|
| Other: Community-2<br>Received RS4 flour first and then control flour | Other: RS4 enriched flour<br>* Wheat flour with 30% resistant starch (type-4)<br>Other: Control flour<br>* Wheat flour without resistant starch (type-4)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in metabolic syndrome risk components |  | 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in anthropometric outcomes | Body weight, body mass index, systolic and diastolic blood pressure, fat mass and fat-free mass | 26 weeks | 
| Changes in blood lipid profile | total cholesterol, LDL cholesterol, HDL cholesterol, non-HDL cholesterol and triglycerides | 26 weeks | 
| Changes in blood glucose indices | fasting blood glucose, postprandial blood glucose and Hemoglobin-A1C | 26 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Obesity, Cardiovascular disease, Metabolic syndrome