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Effects of Hi-maize Resistant Starch on Insulin Sensitivity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01058135
Recruitment Status : Completed
First Posted : January 28, 2010
Last Update Posted : April 21, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Insulin Resistance Other: Hi-maize starch (Low dose) Other: Hi-maize starch (High-dose) Other: Control (starch)

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : January 2010
Primary Completion Date : September 2010
Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Other: Hi-maize starch (Low dose)
    resistant starch
    Other: Hi-maize starch (High-dose)
    resistant starch
    Other: Control (starch)
    rapidly digestible starch

Outcome Measures

Primary Outcome Measures :
  1. insulin sensitivity [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Inflammatory markers, glycemia, serum lipids [ Time Frame: 4 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01058135


Locations
United States, Illinois
Provident Clinical Research and Consulting, Inc
Glen Ellyn, Illinois, United States, 60137
Sponsors and Collaborators
Ingredion Incorporated
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ingredion Incorporated
ClinicalTrials.gov Identifier: NCT01058135     History of Changes
Other Study ID Numbers: 001
First Posted: January 28, 2010    Key Record Dates
Last Update Posted: April 21, 2016
Last Verified: September 2010

Keywords provided by Ingredion Incorporated:
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