Effects of Hi-maize Resistant Starch on Insulin Sensitivity

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01058135

Enrollment

Registered

2010-01-28

Start date

2010-01-31

Completion date

2010-09-30

Last updated

2016-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insulin Resistance

Keywords

insulin resistance, dietary fiber, resistant starch

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.

Interventions

OTHERHi-maize starch (Low dose)

resistant starch

OTHERHi-maize starch (High-dose)

resistant starch

OTHERControl (starch)

rapidly digestible starch

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 69 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
insulin sensitivity	4 weeks

Secondary

Measure	Time frame
Inflammatory markers, glycemia, serum lipids	4 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026