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

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South Dakota State University

Status

Completed

Conditions

Metabolic Syndrome

Treatments

Other: Control flour
Other: RS4 enriched 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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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