NCT00676767

Brief Summary

The purpose of this study was to determine how blood glucose changes after eating energy bars containing resistant starch type 4 compared with bars made with puffed wheat in healthy older adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2006

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

August 1, 2006

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

May 8, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 13, 2008

Completed
Last Updated

May 23, 2008

Status Verified

May 1, 2008

Enrollment Period

3 months

First QC Date

May 8, 2008

Last Update Submit

May 22, 2008

Conditions

Hyperglycemia

Keywords

AgingDiabetesDietFiber

Outcome Measures

Primary Outcomes (1)

  • Glycemic Response

    2-hours

Study Arms (3)

1

EXPERIMENTAL
Dietary Supplement: Resistant Starch Type 4

2

ACTIVE COMPARATOR
Dietary Supplement: Dextrose

3

PLACEBO COMPARATOR
Dietary Supplement: Puffed wheat

Interventions

Resistant Starch Type 4DIETARY_SUPPLEMENT
1
DextroseDIETARY_SUPPLEMENT
2
Puffed wheatDIETARY_SUPPLEMENT
3

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Apparently healthy (not diagnosed with disease)
  • Over 60 years of age

You may not qualify if:

  • Diagnosed with diabetes or other metabolic disorder
  • Allergies to wheat
  • Non-smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Metabolism Laboratory

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 D Haub, Ph.D

    Kansas State University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 8, 2008

First Posted

May 13, 2008

Study Start

August 1, 2006

Primary Completion

November 1, 2006

Study Completion

November 1, 2006

Last Updated

May 23, 2008

Record last verified: 2008-05

Locations

US(1)