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Completed

NCT Number: NCT01887964

Effect of Resistant Starch (Type-4) on 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.

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Key information

Conditions

Metabolic Syndrome Body Weight Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

South Dakota State University

Brookings, South Dakota, 57007, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RS4 enriched flour

Other

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

Control flour

Other

Wheat flour without resistant starch (type-4)

Primary outcomes

  1. Changes in metabolic syndrome risk components

    Time frame: 26 weeks

Secondary outcomes

  1. Changes in anthropometric outcomes

    Time frame: 26 weeks

    Body weight, body mass index, systolic and diastolic blood pressure, fat mass and fat-free mass

  2. Changes in blood lipid profile

    Time frame: 26 weeks

    total cholesterol, LDL cholesterol, HDL cholesterol, non-HDL cholesterol and triglycerides

  3. Changes in blood glucose indices

    Time frame: 26 weeks

    fasting blood glucose, postprandial blood glucose and Hemoglobin-A1C

Sponsors and collaborators

Lead sponsor

South Dakota State University

Other

Registry information

Official study title

Dietary Fiber Intervention in Hutterite Population of South Dakota With and Without Signs of Metabolic Syndrome

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jun 27, 2013
Registry last updated
Sep 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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