ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Dietary Fiber on Insulin Sensitivity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01521806
Recruitment Status : Unknown
Verified January 2012 by Ingredion Incorporated.
Recruitment status was:  Not yet recruiting
First Posted : January 31, 2012
Last Update Posted : January 31, 2012
Sponsor:
Information provided by (Responsible Party):
Ingredion Incorporated

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.

Condition or disease Intervention/treatment Phase
Focus of the Study is Insulin Sensitivity Dietary Supplement: Dietary Fiber Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Dieatry Fiber on Insulin Sensitivity in Pre- and Post-menopausal Women
Study Start Date : January 2012
Estimated Primary Completion Date : January 2012
Estimated Study Completion Date : September 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 :
  1. Mitocondrial function [ Time Frame: 3 times, with a 20-week period ]
    A muscle biospy will be taken to assess mitochondrial function

  2. 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



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Impaired fasting glucose
  • Overweight and obese

Exclusion Criteria:

  • Diabetes, Presence of chronic diseases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Ingredion Incorporated
Investigators
Principal Investigator: Barbara Gower, PhD University of Alabama at Birmingham

Additional Information:
Responsible Party: Ingredion Incorporated
ClinicalTrials.gov Identifier: NCT01521806     History of Changes
Other Study ID Numbers: HM001
First Posted: January 31, 2012    Key Record Dates
Last Update Posted: January 31, 2012
Last Verified: January 2012

Keywords provided by Ingredion Incorporated:
insulin sensitivity
resistant starch

Additional relevant MeSH terms:
Hypersensitivity
Insulin Resistance
Immune System Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs