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Effects of Dietary Fiber on Insulin Sensitivity

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2012 by National Starch LLC.
Recruitment status was:  Not yet recruiting
Information provided by (Responsible Party):
National Starch LLC Identifier:
First received: January 20, 2012
Last updated: January 26, 2012
Last verified: January 2012
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
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:

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 ]
    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 ]
    A muscle biospy will be taken to assess mitochondrial function

  • Meal tolerance test [ Time Frame: 3 times, within a 20-week period ]
    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


Ages Eligible for Study:   19 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Impaired fasting glucose
  • Overweight and obese

Exclusion Criteria:

  • Diabetes, Presence of chronic diseases
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01521806

United States, Alabama
Clinical Research Unit
Birmingham, Alabama, United States, 35249
Sponsors and Collaborators
National Starch LLC
Principal Investigator: Barbara Gower, PhD University of Alabama at Birmingham
  More Information

Responsible Party: National Starch LLC Identifier: NCT01521806     History of Changes
Other Study ID Numbers: HM001 
Study First Received: January 20, 2012
Last Updated: January 26, 2012

Keywords provided by National Starch LLC:
insulin sensitivity
resistant starch

Additional relevant MeSH terms:
Insulin Resistance
Immune System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on February 20, 2017