MedPath

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

Not Applicable
Completed
Conditions
Metabolic Syndrome
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

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
Primary Outcome Measures
NameTimeMethod
Changes in metabolic syndrome risk components26 weeks
Secondary Outcome Measures
NameTimeMethod
Changes in blood glucose indices26 weeks

fasting blood glucose, postprandial blood glucose and Hemoglobin-A1C

Changes in anthropometric outcomes26 weeks

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

Changes in blood lipid profile26 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

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

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.