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CompletedNCT01058135Updated Apr 21, 2016

Effects of Hi-maize Resistant Starch on Insulin Sensitivity

An interventional study of Hi-maize starch (Low dose) and Hi-maize starch (High-dose) in Insulin Resistance, sponsored by Ingredion Incorporated. Completed at 1 site in United States. Open to participants aged 18 Years to 69 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-04-21.

Sponsored by Ingredion Incorporated · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years to 69 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Insulin Resistance

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Keywords

  • insulin resistance
  • dietary fiber
  • resistant starch
03

In context

Insulin Resistance

1,960 studies on the registry are indexed under Insulin Resistance; 306 are open to participants now.

This study's enrollment of 32 is below the median of 40 across 1,536 interventional studies indexed under Insulin Resistance.

Browse Insulin Resistance studies →

Lead sponsor

Ingredion Incorporated is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 69 Years
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • Diabetes
  • other serious illnesses
  • use of medications that affect outcomes
  • BMI > or = 35.0 kg/m2
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
32 participants (actual)

Interventions

  • OtherHi-maize starch (Low dose)

    resistant starch

  • OtherHi-maize starch (High-dose)

    resistant starch

  • OtherControl (starch)

    rapidly digestible starch

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What researchers measure

Primary outcomes

  1. insulin sensitivity

    Time frame: 4 weeks

Secondary outcomes

  1. Inflammatory markers, glycemia, serum lipids

    Time frame: 4 weeks

07

Study locations

1 site
  • Provident Clinical Research and Consulting, Inc
    Glen Ellyn, Illinois 60137, United States
08

References and documents

Publications

  • 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. PubMed 22357745 ↗

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 21, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01058135
Lead sponsor
Ingredion Incorporated
Responsible party
Sponsor
First posted
Jan 28, 2010
Start date
Jan 2010
Primary completion
Sep 2010
Completion
Sep 2010
Last update
Apr 21, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.

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