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

Not Applicable

Completed

• Conditions: Metabolic Syndrome
• Interventions: Other: RS4 enriched flour; Other: Control flour

• Registration Number: NCT01887964
• Lead Sponsor: South Dakota State University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Study First Submitted: 2013-06-20
• Study First Submitted QC: 2013-06-24
• Study First Posted: 2013-06-27
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-21
• Last Update Posted: 2021-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Community-1	Control flour	Received control flour first and then Resistant starch type 4 (RS4) flour
Community-1	RS4 enriched flour	Received control flour first and then Resistant starch type 4 (RS4) flour
Community-2	RS4 enriched flour	Received RS4 flour first and then control flour
Community-2	Control flour	Received RS4 flour first and then control flour

Primary Outcome Measures

Name	Time	Method
Changes in metabolic syndrome risk components	26 weeks

Secondary Outcome Measures

Name	Time	Method
Changes in blood glucose indices	26 weeks	fasting blood glucose, postprandial blood glucose and Hemoglobin-A1C
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

Trial Locations

Locations (1)

South Dakota State University; 🇺🇸 Brookings, South Dakota, United States