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

September 21, 2021 updated by: Moul Dey, South Dakota State University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Dakota
      • Brookings, South Dakota, United States, 57007
        • South Dakota State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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)
Other: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in metabolic syndrome risk components
Time Frame: 26 weeks
26 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

South Dakota State University

Investigators

  • Principal Investigator: Moul Dey, PhD, South Dakota State University
  • Principal Investigator: Bonny Specker, PhD, South Dakota State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

June 20, 2013

First Submitted That Met QC Criteria

June 24, 2013

First Posted (Estimate)

June 27, 2013

Study Record Updates

Last Update Posted (Actual)

September 27, 2021

Last Update Submitted That Met QC Criteria

September 21, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1112012-CR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant's identity will not be shared. This clinical trial is complete. All results were published as two research articles: PMCID: PMC4928084 and PMCID: PMC4048643. Raw sequence data were submitted to Sequence Read archive as referenced in the manuscript PMC4928084.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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