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Effects of Hi-maize Resistant Starch on Insulin Sensitivity

This study has been completed.
Sponsor:
Information provided by:
National Starch LLC
ClinicalTrials.gov Identifier:
NCT01058135
First received: January 26, 2010
Last updated: September 15, 2010
Last verified: September 2010
History of Changes
  Purpose

The purpose of this study is to determine the effects of a dietary fiber, resistant starch, on insulin sensitivity. Low insulin sensitivity is a risk factor for some diseases including type 2 diabetes and heart disease. This study will show if consuming resistant starch can help improve insulin sensitivity in overweight and obese people.


Condition Intervention
Insulin Resistance
 Other: Hi-maize starch (Low dose)
Other: Hi-maize starch (High-dose)
Other: Control (starch)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Controlled, Double-blind Crossover Study to Assess the Effects of a Dietary Fiber Ingredient, at Two Doses, on Insulin Sensitivity

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Starch LLC:

Primary Outcome Measures:
  • insulin sensitivity [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Inflammatory markers, glycemia, serum lipids [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: January 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Hi-maize starch (Low dose)
    resistant starch
    Other: Hi-maize starch (High-dose)
    resistant starch
    Other: Control (starch)
    rapidly digestible starch
  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Stable body weight
  • No serious health conditions
  • Waist circumference > or = to 89 cm (females) and 102 cm (males)

Exclusion Criteria:

  • Diabetes
  • other serious illnesses
  • use of medications that affect outcomes
  • BMI > or = 35.0 kg/m2
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01058135

Locations
United States, Illinois
Provident Clinical Research and Consulting, Inc
Glen Ellyn, Illinois, United States, 60137
Sponsors and Collaborators
National Starch LLC
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided by National Starch LLC

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Christine Pelkman, PhD, National Starch LLC
ClinicalTrials.gov Identifier: NCT01058135     History of Changes
Other Study ID Numbers: 001
Study First Received: January 26, 2010
Last Updated: September 15, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by National Starch LLC:
insulin resistance
dietary fiber
resistant starch

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
 Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013