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

South Dakota State University

Status: Completed

Conditions: Metabolic Syndrome

Treatments: Other: RS4 enriched flour; Other: Control flour

Study type: Interventional

Funder types: Other

Identifiers

NCT01887964

1112012-CR

Details and patient eligibility

About

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.

Enrollment: 86 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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86 participants in 2 patient groups

Community-1

Other group

Description:

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

Treatment:

Other: RS4 enriched flour

Other: Control flour

Community-2

Other group

Description:

Received RS4 flour first and then control flour

Treatment:

Other: RS4 enriched flour

Other: Control flour