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Effects of Hi-maize Resistant Starch on Insulin Sensitivity

Primary Purpose

Insulin Resistance

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hi-maize starch (Low dose)
Hi-maize starch (High-dose)
Control (starch)
Sponsored by
Ingredion Incorporated
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Insulin Resistance focused on measuring insulin resistance, dietary fiber, resistant starch

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Provident Clinical Research and Consulting, Inc

Outcomes

Primary Outcome Measures

insulin sensitivity

Secondary Outcome Measures

Inflammatory markers, glycemia, serum lipids

Full Information

First Posted
January 26, 2010
Last Updated
April 20, 2016
Sponsor
Ingredion Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT01058135
Brief Title
Effects of Hi-maize Resistant Starch on Insulin Sensitivity
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 Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ingredion Incorporated

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance
Keywords
insulin resistance, dietary fiber, resistant starch

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
Hi-maize starch (Low dose)
Intervention Description
resistant starch
Intervention Type
Other
Intervention Name(s)
Hi-maize starch (High-dose)
Intervention Description
resistant starch
Intervention Type
Other
Intervention Name(s)
Control (starch)
Intervention Description
rapidly digestible starch
Primary Outcome Measure Information:
Title
insulin sensitivity
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Inflammatory markers, glycemia, serum lipids
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Provident Clinical Research and Consulting, Inc
City
Glen Ellyn
State/Province
Illinois
ZIP/Postal Code
60137
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22357745
Citation
Maki KC, Pelkman CL, Finocchiaro ET, Kelley KM, Lawless AL, Schild AL, Rains TM. Resistant starch from high-amylose maize increases insulin sensitivity in overweight and obese men. J Nutr. 2012 Apr;142(4):717-23. doi: 10.3945/jn.111.152975. Epub 2012 Feb 22.
Results Reference
derived
Links:
URL
http://www.resistantstarch.com
Description
Related Info

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Effects of Hi-maize Resistant Starch on Insulin Sensitivity

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