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NCT01058135 Clinical Trial

Effects of Hi-maize Resistant Starch on Insulin Sensitivity

Insulin Resistance Clinical Trial

Official title:
A Randomized, Controlled, Double-blind Crossover Study to Assess the Effects of a Dietary Fiber Ingredient, at Two Doses, on Insulin Sensitivity

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01058135
Other study ID # 001
Secondary ID
Status Completed
Phase N/A
First received January 26, 2010
Last updated April 20, 2016
Start date January 2010
Est. completion date September 2010

Study information
Verified date September 2010
Source National Starch LLC
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 32
Est. completion date September 2010
Est. primary completion date September 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 69 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Provident Clinical Research and Consulting, Inc Glen Ellyn Illinois

Sponsors (1)
Lead Sponsor Collaborator
National Starch LLC

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary insulin sensitivity 4 weeks No
Secondary Inflammatory markers, glycemia, serum lipids 4 weeks No
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