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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Community-1

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

Group Type OTHER

RS4 enriched flour

Intervention Type OTHER

Wheat flour with 30% resistant starch (type-4)

Control flour

Intervention Type OTHER

Wheat flour without resistant starch (type-4)

Community-2

Received RS4 flour first and then control flour

Group Type OTHER

RS4 enriched flour

Intervention Type OTHER

Wheat flour with 30% resistant starch (type-4)

Control flour

Intervention Type OTHER

Wheat flour without resistant starch (type-4)

Interventions

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RS4 enriched flour

Wheat flour with 30% resistant starch (type-4)

Intervention Type OTHER

Control flour

Wheat flour without resistant starch (type-4)

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes