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

This study has been completed.
Information provided by (Responsible Party):
Moul Dey, South Dakota State University Identifier:
First received: June 20, 2013
Last updated: June 24, 2013
Last verified: June 2013
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.

Condition Intervention
Metabolic Syndrome
Other: RS4 enriched flour
Other: Control flour

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Dietary Fiber Intervention in Hutterite Population of South Dakota With and Without Signs of Metabolic Syndrome

Resource links provided by NLM:

Further study details as provided by Moul Dey, South Dakota State University:

Primary Outcome Measures:
  • Changes in metabolic syndrome risk components [ Time Frame: 26 weeks ]

Secondary Outcome Measures:
  • Changes in anthropometric outcomes [ Time Frame: 26 weeks ]
    Body weight, body mass index, systolic and diastolic blood pressure, fat mass and fat-free mass

  • Changes in blood lipid profile [ Time Frame: 26 weeks ]
    total cholesterol, LDL cholesterol, HDL cholesterol, non-HDL cholesterol and triglycerides

  • Changes in blood glucose indices [ Time Frame: 26 weeks ]
    fasting blood glucose, postprandial blood glucose and Hemoglobin-A1C

Enrollment: 86
Study Start Date: March 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Received control flour first and then Resistant starch type 4 (RS4) flour
Other: RS4 enriched flour
Wheat flour with 30% resistant starch (type-4)
Other: Control flour
Wheat flour without resistant starch (type-4)
Received RS4 flour first and then control flour
Other: RS4 enriched flour
Wheat flour with 30% resistant starch (type-4)
Other: Control flour
Wheat flour without resistant starch (type-4)


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT01887964

United States, South Dakota
South Dakota State University
Brookings, South Dakota, United States, 57007
Sponsors and Collaborators
South Dakota State University
Principal Investigator: Moul Dey, PhD South Dakota State University
Principal Investigator: Bonny Specker, PhD South Dakota State University
  More Information

Responsible Party: Moul Dey, Associate Professor, South Dakota State University Identifier: NCT01887964     History of Changes
Other Study ID Numbers: 1112012-CR
Study First Received: June 20, 2013
Last Updated: June 24, 2013

Keywords provided by Moul Dey, South Dakota State University:
Cardiovascular disease
Metabolic syndrome

Additional relevant MeSH terms:
Metabolic Syndrome X
Pathologic Processes
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases processed this record on May 25, 2017