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

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01887964
• Other study ID #: 1112012-CR
• Status: Completed
• Phase: N/A
• Start date: March 2012
• Est. completion date: October 2012

Study information

• Verified date: September 2021
• Source: South Dakota State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Syndrome

Intervention

Other:
• RS4 enriched flour
Wheat flour with 30% resistant starch (type-4)
• Control flour
Wheat flour without resistant starch (type-4)

Locations

Country	Name	City	State
United States	South Dakota State University	Brookings	South Dakota

Sponsors (1)

Lead Sponsor	Collaborator
South Dakota State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in metabolic syndrome risk components		26 weeks
Secondary	Changes in anthropometric outcomes	Body weight, body mass index, systolic and diastolic blood pressure, fat mass and fat-free mass	26 weeks
Secondary	Changes in blood lipid profile	total cholesterol, LDL cholesterol, HDL cholesterol, non-HDL cholesterol and triglycerides	26 weeks
Secondary	Changes in blood glucose indices	fasting blood glucose, postprandial blood glucose and Hemoglobin-A1C	26 weeks