NCT01521806

Brief Summary

This study will examine the effects of a dietary fiber on insulin sensitivity in overweight and obese women. The fiber will be added to snack foods and women will consume the foods for four weeks. In one four-week period, 15 g of fiber will be added, and 30 g will added in another period. In a third period, no fiber will be added to the snack foods. Insulin senstivity will be measured at the end of each treatment period.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
unknown

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, 2012

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

January 20, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 31, 2012

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

January 31, 2012

Status Verified

January 1, 2012

Enrollment Period

Same day

First QC Date

January 20, 2012

Last Update Submit

January 26, 2012

Conditions

Focus of the Study is Insulin Sensitivity

Keywords

insulin sensitivityresistant starch

Outcome Measures

Primary Outcomes (1)

  • Insulin sensitivity

    A frequently sampled intravenous blood glucose tolerance test will be performed.

    5-hr test, performed 3 times within a 20-week period

Secondary Outcomes (2)

  • Mitocondrial function

    3 times, with a 20-week period

  • Meal tolerance test

    3 times, within a 20-week period

Study Arms (3)

Low dose

EXPERIMENTAL

15 g of fiber per day will be added to snack foods

Dietary Supplement: Dietary Fiber

High dose

EXPERIMENTAL

30 g of fiber per day will be added to snack foods

Dietary Supplement: Dietary Fiber

No fiber

PLACEBO COMPARATOR

Snack foods without fiber will be given

Dietary Supplement: Dietary Fiber

Interventions

Dietary FiberDIETARY_SUPPLEMENT

Dietary fiber will be added to snack foods

High doseLow doseNo fiber

Eligibility Criteria

Age19 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Impaired fasting glucose
  • Overweight and obese

You may not qualify if:

  • Diabetes, Presence of chronic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Research Unit

Birmingham, Alabama, 35249, United States

Location

Related Links

MeSH Terms

Conditions

Insulin Resistance

Interventions

Dietary Fiber

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dietary CarbohydratesCarbohydratesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Barbara Gower, PhD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Brandon Kane

CONTACT

205-975-9629kane003@uab.edu

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
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2012

First Posted

January 31, 2012

Study Start

January 1, 2012

Primary Completion

January 1, 2012

Study Completion

September 1, 2013

Last Updated

January 31, 2012

Record last verified: 2012-01

Locations

US(1)