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

June 20, 2013
June 24, 2013
March 2012
October 2012   (final data collection date for primary outcome measure)
Changes in metabolic syndrome risk components [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01887964 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Effect of Resistant Starch (Type-4) on Metabolic Syndrome
Dietary Fiber Intervention in Hutterite Population of South Dakota With and Without Signs of Metabolic Syndrome

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Metabolic Syndrome
  • Other: RS4 enriched flour
    Wheat flour with 30% resistant starch (type-4)
  • Other: Control flour
    Wheat flour without resistant starch (type-4)
  • Community-1
    Received control flour first and then Resistant starch type 4 (RS4) flour
    Interventions:
    • Other: RS4 enriched flour
    • Other: Control flour
  • Community-2
    Received RS4 flour first and then control flour
    Interventions:
    • Other: RS4 enriched flour
    • Other: Control flour
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
86
October 2012
October 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01887964
1112012-CR
No
Moul Dey, South Dakota State University
South Dakota State University
Not Provided
Principal Investigator: Moul Dey, PhD South Dakota State University
Principal Investigator: Bonny Specker, PhD South Dakota State University
South Dakota State University
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP