Effects of Dietary Fiber on Insulin Sensitivity

• ClinicalTrials.gov Identifier: NCT01521806
• Recruitment Status: Unknown
• First Posted: January 31, 2012
• Last Update Posted: January 31, 2012
• Sponsor: Ingredion Incorporated
• Information provided by (Responsible Party): Ingredion Incorporated

Tracking Information

• First Submitted Date: January 20, 2012
• First Posted Date: January 31, 2012
• Last Update Posted Date: January 31, 2012
• Study Start Date: January 2012
• Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 26, 2012)

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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: January 26, 2012)

• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effects of Dietary Fiber on Insulin Sensitivity
• Official Title: Effects of Dieatry Fiber on Insulin Sensitivity in Pre- and Post-menopausal Women
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Prevention
• Condition: Focus of the Study is Insulin Sensitivity

Intervention

Dietary Supplement: Dietary Fiber

Dietary fiber will be added to snack foods

Study Arms

• Experimental: Low dose
  15 g of fiber per day will be added to snack foods
  Intervention: Dietary Supplement: Dietary Fiber
• Experimental: High dose
  30 g of fiber per day will be added to snack foods
  Intervention: Dietary Supplement: Dietary Fiber
• Placebo Comparator: No fiber
  Snack foods without fiber will be given
  Intervention: Dietary Supplement: Dietary Fiber

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: January 26, 2012): 40
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 2013
• Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Impaired fasting glucose
• Overweight and obese

Exclusion Criteria:

• Diabetes, Presence of chronic diseases

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 19 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01521806
• Other Study ID Numbers: HM001
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Ingredion Incorporated
• Study Sponsor: Ingredion Incorporated
• Collaborators: Not Provided

Investigators

• Principal Investigator: Barbara Gower, PhD; University of Alabama at Birmingham

• PRS Account: Ingredion Incorporated
• Verification Date: January 2012