NCT00687960

Brief Summary

This study tested the effects of resistant starch type 4 on blood sugar and hunger in young adults with Type 2 diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2006

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

November 1, 2006

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 2, 2008

Completed
Last Updated

June 2, 2008

Status Verified

May 1, 2008

Enrollment Period

6 months

First QC Date

May 22, 2008

Last Update Submit

May 28, 2008

Conditions

Hyperglycemia

Keywords

DiabetesDietFiberAge

Outcome Measures

Primary Outcomes (1)

  • Post-Prandial Metabolism

    Early morning

Study Arms (4)

1

EXPERIMENTAL

Resistant Starch Type 4-Raw

Dietary Supplement: Resistant starch type 4 - raw

2

EXPERIMENTAL

Resistant Starch Type 4-cooked

Dietary Supplement: Resistant Starch Type 4 - Cooked

3

ACTIVE COMPARATOR

Puffed wheat

Dietary Supplement: Puffed Wheat

4

PLACEBO COMPARATOR

Dextrose

Dietary Supplement: Dextrose

Interventions

Resistant starch type 4 - rawDIETARY_SUPPLEMENT

Dose: 80g bar containing Resistant Starch Type 4 - raw

1
Resistant Starch Type 4 - CookedDIETARY_SUPPLEMENT

Dose: 80g bar containing Resistant Starch Type 4 - cooked

2
DextroseDIETARY_SUPPLEMENT

Dose: 7 oz of oral glucose tolerance beverage

4
Puffed WheatDIETARY_SUPPLEMENT

Dose: 80g bar containing puffed wheat cereal

3

Eligibility Criteria

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

You may qualify if:

  • Apparently Healthy (not diagnosed with disease)
  • Young Adults (18-35)

You may not qualify if:

  • Diagnosed with diabetes or other metabolic disorders
  • Allergies to Wheat
  • Non-smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kansas State University

Manhattan, Kansas, 66506, United States

Location

MeSH Terms

Conditions

HyperglycemiaDiabetes Mellitus

Interventions

Glucose

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydrates

Study Officials

  • Mark Haub, Ph.D.

    Department of Human Nutrition

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 22, 2008

First Posted

June 2, 2008

Study Start

November 1, 2006

Primary Completion

May 1, 2007

Study Completion

December 1, 2007

Last Updated

June 2, 2008

Record last verified: 2008-05

Locations

US(1)