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

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ClinicalTrials.gov Identifier: NCT01887964
Recruitment Status : Completed
First Posted : June 27, 2013
Last Update Posted : June 27, 2013
Sponsor:
Information provided by (Responsible Party):
Moul Dey, South Dakota State University

Brief Summary:
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 or disease Intervention/treatment Phase
Metabolic Syndrome Other: RS4 enriched flour Other: Control flour Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Dietary Fiber Intervention in Hutterite Population of South Dakota With and Without Signs of Metabolic Syndrome
Study Start Date : March 2012
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Starch
U.S. FDA Resources

Arm Intervention/treatment
Community-1
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)
Community-2
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)



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

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

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

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



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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01887964


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

Responsible Party: Moul Dey, Associate Professor, South Dakota State University
ClinicalTrials.gov Identifier: NCT01887964     History of Changes
Other Study ID Numbers: 1112012-CR
First Posted: June 27, 2013    Key Record Dates
Last Update Posted: June 27, 2013
Last Verified: June 2013

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

Additional relevant MeSH terms:
Syndrome
Metabolic Syndrome X
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases