NCT00930956

Brief Summary

This study is to determine whether different types of resistant starch have different effects on blood glucose in healthy adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2006

Typical duration 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

May 1, 2006

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 2, 2009

Completed
Last Updated

July 29, 2010

Status Verified

June 1, 2009

Enrollment Period

3 years

First QC Date

June 30, 2009

Last Update Submit

July 28, 2010

Conditions

Postprandial Hyperglycemia

Keywords

DiabetesObesityHyperglycemiaDietary FiberWheatGrain

Outcome Measures

Primary Outcomes (1)

  • Blood glucose

    Acute response -- fasting and 30, 60, 90 and 120 minutes post-ingestion

Study Arms (3)

Dextrose

ACTIVE COMPARATOR

30 g of carbohydrate via Sun-Dex OGTT beverage

Dietary Supplement: Resistant Starch

RS Type 2

EXPERIMENTAL

30g Resistant Starch Type 2 (Hi-Maize 260, National Starch)

Dietary Supplement: Resistant Starch

RS Type 4 (cross linked)

EXPERIMENTAL

30g of cross linked RS type 4 (Fibersym RW, MGP Ingredients, Inc.)

Dietary Supplement: Resistant Starch

Interventions

Resistant StarchDIETARY_SUPPLEMENT

30 g of carbohydrate per Arm

Also known as: Hi-Maize 260, Fibersym RW
DextroseRS Type 2RS Type 4 (cross linked)

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • apparently healthy

You may not qualify if:

  • diagnosis of any chronic disease
  • wheat allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Metabolism Laboratory (K-State Univ.)

Manhattan, Kansas, 66502, United States

Location

MeSH Terms

Conditions

HyperglycemiaDiabetes MellitusObesity

Interventions

Resistant Starchhigh-amylose maize type 2 resistant starch, maize

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

StarchGlucansBiopolymersPolymersMacromolecular SubstancesDietary FiberDietary CarbohydratesCarbohydratesPolysaccharidesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Mark D Haub, Ph.D.

    Kansas State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 30, 2009

First Posted

July 2, 2009

Study Start

May 1, 2006

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

July 29, 2010

Record last verified: 2009-06

Locations

US(1)