Effect of Fiber Supplementation in Children With Type 1 Diabetes

NCT ID: NCT01399892

Last Updated: 2011-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2010-12-31

Brief Summary

High fiber foods are recommended as a preferential source of carbohydrate by the Nutrition Study Group of the European Association for the Study of Diabetes. Dietary fibers may delay glucose absorption and reduce postprandial glycemic excursion. They also appear to have a beneficial effect on cholesterol levels. It has been shown, in few short term adult studies, that high fiber foods reduce postprandial blood glucose levels. The American Diabetes Association feels that there is little evidence confirming the positive effect of high fiber foods on blood glucose control. It is not clear whether a high fiber diet can improve glycemic control and/or reduce the risk of hypoglycemic events. Our hypothesis is that children with type 1 diabetes will benefit from having added fibers in their diet. The investigators plan to study blood glucose values using a continuous blood glucose monitor before and after dietary fibers are introduced. This will help us determine whether a diet rich in fiber should be recommended in all children with type 1 diabetes mellitus

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

soluble fiber in the form of benefiber

Benefiber, sugar free in an amount to total 20gms/1000kcal/day of fiber

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

Inclusion Criteria:

• The inclusion criteria are: Diagnosis of type I diabetes for at least two years prior to enrollment, the ability tolerate wearing the continuous blood glucose monitoring device for a total of 6 days, and the ability to follow a prescribed meal plan.

Exclusion Criteria:

• The exclusion criteria are: Medical conditions that could potentially affect the absorption of nutrients such as celiac disease of inflammatory bowel disease and the use of any fiber supplements at home.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Mayo Clinic

Principal Investigators

Aida N Lteif, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Other Identifiers

08-002142

Identifier Type: -

Identifier Source: org_study_id