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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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 October 02, 2014