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OpenTrials
Completed

NCT Number: NCT01058135

Effects of Hi-maize Resistant Starch on Insulin Sensitivity

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.

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Key information

Conditions

Insulin Resistance Glucose Metabolism Disorders Hyperinsulinism Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Provident Clinical Research and Consulting, Inc

Glen Ellyn, Illinois, 60137, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hi-maize starch (Low dose)

Other

resistant starch

Hi-maize starch (High-dose)

Other

resistant starch

Control (starch)

Other

rapidly digestible starch

Primary outcomes

  1. insulin sensitivity

    Time frame: 4 weeks

Secondary outcomes

  1. Inflammatory markers, glycemia, serum lipids

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Ingredion Incorporated

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jan 28, 2010
Registry last updated
Apr 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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