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

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RS4 enriched flour
Control flour
Sponsored by
South Dakota State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolic Syndrome focused on measuring Diabetes, Obesity, Cardiovascular disease, Metabolic syndrome

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • South Dakota State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Community-1

Community-2

Arm Description

Received control flour first and then Resistant starch type 4 (RS4) flour

Received RS4 flour first and then control flour

Outcomes

Primary Outcome Measures

Changes in metabolic syndrome risk components

Secondary Outcome Measures

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

Full Information

First Posted
June 20, 2013
Last Updated
September 21, 2021
Sponsor
South Dakota State University
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1. Study Identification

Unique Protocol Identification Number
NCT01887964
Brief Title
Effect of Resistant Starch (Type-4) on Metabolic Syndrome
Official Title
Dietary Fiber Intervention in Hutterite Population of South Dakota With and Without Signs of Metabolic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
South Dakota State University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
Diabetes, Obesity, Cardiovascular disease, Metabolic syndrome

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Community-1
Arm Type
Other
Arm Description
Received control flour first and then Resistant starch type 4 (RS4) flour
Arm Title
Community-2
Arm Type
Other
Arm Description
Received RS4 flour first and then control flour
Intervention Type
Other
Intervention Name(s)
RS4 enriched flour
Intervention Description
Wheat flour with 30% resistant starch (type-4)
Intervention Type
Other
Intervention Name(s)
Control flour
Intervention Description
Wheat flour without resistant starch (type-4)
Primary Outcome Measure Information:
Title
Changes in metabolic syndrome risk components
Time Frame
26 weeks
Secondary Outcome Measure Information:
Title
Changes in anthropometric outcomes
Description
Body weight, body mass index, systolic and diastolic blood pressure, fat mass and fat-free mass
Time Frame
26 weeks
Title
Changes in blood lipid profile
Description
total cholesterol, LDL cholesterol, HDL cholesterol, non-HDL cholesterol and triglycerides
Time Frame
26 weeks
Title
Changes in blood glucose indices
Description
fasting blood glucose, postprandial blood glucose and Hemoglobin-A1C
Time Frame
26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moul Dey, PhD
Organizational Affiliation
South Dakota State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bonny Specker, PhD
Organizational Affiliation
South Dakota State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
South Dakota State University
City
Brookings
State/Province
South Dakota
ZIP/Postal Code
57007
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.
Citations:
PubMed Identifier
36337613
Citation
Dhakal S, Dey M. Resistant starch type-4 intake alters circulating bile acids in human subjects. Front Nutr. 2022 Oct 20;9:930414. doi: 10.3389/fnut.2022.930414. eCollection 2022.
Results Reference
derived

Learn more about this trial

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

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