NCT01058135

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 28, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

April 21, 2016

Status Verified

September 1, 2010

Enrollment Period

8 months

First QC Date

January 26, 2010

Last Update Submit

April 20, 2016

Conditions

Insulin Resistance

Keywords

insulin resistancedietary fiberresistant starch

Outcome Measures

Primary Outcomes (1)

  • insulin sensitivity

    4 weeks

Secondary Outcomes (1)

  • Inflammatory markers, glycemia, serum lipids

    4 weeks

Interventions

Hi-maize starch (Low dose)OTHER

resistant starch

Hi-maize starch (High-dose)OTHER

resistant starch

Control (starch)OTHER

rapidly digestible starch

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stable body weight
  • No serious health conditions
  • Waist circumference \> or = to 89 cm (females) and 102 cm (males)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Provident Clinical Research and Consulting, Inc

Glen Ellyn, Illinois, 60137, United States

Location

Related Publications (1)

  • 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.

    PMID: 22357745DERIVED

Related Links

MeSH Terms

Conditions

Insulin Resistance

Interventions

Starch

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

GlucansBiopolymersPolymersMacromolecular SubstancesDietary CarbohydratesCarbohydratesPolysaccharides

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2010

First Posted

January 28, 2010

Study Start

January 1, 2010

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

April 21, 2016

Record last verified: 2010-09

Locations

US(1)