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Effects of Dietary Fiber on Insulin Sensitivity

This study is not yet open for participant recruitment.
Verified January 2012 by National Starch LLC
Sponsor:
Information provided by (Responsible Party):
National Starch LLC
ClinicalTrials.gov Identifier:
NCT01521806
First received: January 20, 2012
Last updated: January 26, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention
Focus of the Study is Insulin Sensitivity
 Dietary Supplement: Dietary Fiber

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Dieatry Fiber on Insulin Sensitivity in Pre- and Post-menopausal Women

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Starch LLC:

Primary Outcome Measures:
  • Insulin sensitivity [ Time Frame: 5-hr test, performed 3 times within a 20-week period ] [ Designated as safety issue: No ]
    A frequently sampled intravenous blood glucose tolerance test will be performed.


Secondary Outcome Measures:
  • Mitocondrial function [ Time Frame: 3 times, with a 20-week period ] [ Designated as safety issue: No ]
    A muscle biospy will be taken to assess mitochondrial function

  • Meal tolerance test [ Time Frame: 3 times, within a 20-week period ] [ Designated as safety issue: No ]
    A high-fat meal will be given and blood will be drawn over a three-hr period


Estimated Enrollment: 40
Study Start Date: January 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low dose
15 g of fiber per day will be added to snack foods
 Dietary Supplement: Dietary Fiber
Dietary fiber will be added to snack foods
Experimental: High dose
30 g of fiber per day will be added to snack foods
 Dietary Supplement: Dietary Fiber
Dietary fiber will be added to snack foods
Placebo Comparator: No fiber
Snack foods without fiber will be given
 Dietary Supplement: Dietary Fiber
Dietary fiber will be added to snack foods

  Eligibility

Ages Eligible for Study:   19 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Impaired fasting glucose
  • Overweight and obese

Exclusion Criteria:

  • Diabetes, Presence of chronic diseases
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01521806

Contacts
Contact: Brandon Kane 205-975-9629 kane003@uab.edu

Locations
United States, Alabama
Clinical Research Unit Not yet recruiting
Birmingham, Alabama, United States, 35249
Contact: Brandon Kane     205-975-9629     kane003@uab.edu    
Principal Investigator: Barbara Gower, PhD            
Sponsors and Collaborators
National Starch LLC
Investigators
Principal Investigator: Barbara Gower, PhD University of Alabama at Birmingham
  More Information

Additional Information:
clinical center  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: National Starch LLC
ClinicalTrials.gov Identifier: NCT01521806     History of Changes
Other Study ID Numbers: HM001
Study First Received: January 20, 2012
Last Updated: January 26, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by National Starch LLC:
insulin sensitivity
resistant starch

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
 Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013