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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Moul Dey, South Dakota State University
ClinicalTrials.gov Identifier:
NCT01887964
First received: June 20, 2013
Last updated: June 24, 2013
Last verified: June 2013
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 South Dakota State University:

Primary Outcome Measures:
  • Changes in metabolic syndrome risk components [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in anthropometric outcomes [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    total cholesterol, LDL cholesterol, HDL cholesterol, non-HDL cholesterol and triglycerides

  • Changes in blood glucose indices [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    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
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)

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Moul Dey, Associate Professor, South Dakota State University
ClinicalTrials.gov Identifier: NCT01887964     History of Changes
Other Study ID Numbers: 1112012-CR
Study First Received: June 20, 2013
Last Updated: June 24, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on September 18, 2014