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

Sponsor

South Dakota State University (Other)

Overall Status

Completed

CT.gov ID

NCT01887964

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

12.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Metabolic Syndrome	Other: RS4 enriched flour Other: Control flour	N/A

Study Design

Study Type:

Interventional

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 :

Mar 1, 2012

Actual Primary Completion Date :

Oct 1, 2012

Actual Study Completion Date :

Oct 1, 2012

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

Changes in metabolic syndrome risk components [26 weeks]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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