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

NCT01887964 | Completed

• 1 other identifier: 1112012-CR
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome

Keywords

Diabetes; Obesity; Cardiovascular disease; Metabolic syndrome

Outcome Measures

Primary Outcomes (1)

• Changes in metabolic syndrome risk components

  26 weeks

Secondary Outcomes (3)

• Changes in anthropometric outcomes

  26 weeks

• Changes in blood lipid profile

  26 weeks

• Changes in blood glucose indices

  26 weeks

Study Arms (2)

Community-1

OTHER

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

Other: RS4 enriched flour; Other: Control flour

Community-2

OTHER

Received RS4 flour first and then control flour

Other: RS4 enriched flour; Other: Control flour

Interventions

RS4 enriched flour OTHER

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

Community-1; Community-2

Control flour OTHER

Wheat flour without resistant starch (type-4)

Community-1; Community-2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Any individual aged 18-80 years

You may not qualify if:

• 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

Sponsors & Collaborators

• South Dakota State University: lead

Study Sites (1)

South Dakota State University

Brookings, South Dakota, 57007, United States

Location

Related Publications (1)

• Dhakal S, Dey M. Resistant starch type-4 intake alters circulating bile acids in human subjects. Front Nutr. 2022 Oct 20;9:930414. doi: 10.3389/fnut.2022.930414. eCollection 2022.

  PMID: 36337613 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome; Diabetes Mellitus; Obesity; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Moul Dey, PhD

  South Dakota State University

  PRINCIPAL INVESTIGATOR

• Bonny Specker, PhD

  South Dakota State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 20, 2013
• First Posted: June 27, 2013
• Study Start: March 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: September 27, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)