Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT01058135
NCT01058135CompletedNot Applicable

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

Ingredion Incorporated2 sites in 1 country32 target enrollmentStarted: January 2010Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
32
Locations
2
Primary Endpoint
insulin sensitivity
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 69 Years (Adult, Older Adult)
Sex
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

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

Outcomes

Primary Outcomes

insulin sensitivity

Time Frame: 4 weeks

Secondary Outcomes

  • Inflammatory markers, glycemia, serum lipids(4 weeks)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

Loading locations...

Similar Trials

Completed
Not Applicable
Resistant Starch Blend Gastrointestinal ImpactQuality of LifeHealth, Subjective
NCT03983772Metagenics, Inc.43
Terminated
Phase 2
Pilot Trial of Resistant Starch in Stage I-III Colorectal Cancer SurvivorsRectal CancerCancer SurvivorColorectal AdenocarcinomaStage I Colorectal Cancer AJCC v8Stage II Colorectal Cancer AJCC v8Stage IIA Colorectal Cancer AJCC v8Stage IIB Colorectal Cancer AJCC v8Stage IIC Colorectal Cancer AJCC v8Stage III Colorectal Cancer AJCC v8Stage IIIA Colorectal Cancer AJCC v8Colon CancerStage IIIB Colorectal Cancer AJCC v8Stage IIIC Colorectal Cancer AJCC v8
NCT03781778Fred Hutchinson Cancer Center10
Active, not recruiting
Not Applicable
Resistant Starch in Pediatric Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis)Inflammatory Bowel DiseasesUlcerative ColitisCrohn Disease
NCT04522271Children's Hospital of Eastern Ontario80
Completed
Not Applicable
The Effect of a High Protein, High Fiber Dietary Supplement on Weight and Fat LossOverweight
NCT03057873Beachbody206
Terminated
Not Applicable
Effects of Novel Fiber on Glucose Homeostasis in Individuals at Risk for DiabetesInsulin Resistance
NCT00820807Cargill60