NCT03334643

Fiber Mix and Glycemic Response

The Effect of a Dietary Fiber Mix on Glycemic Response in Human: a Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study determines the acute effect of a dietary fiber mix on blood glucose levels. Participants will consume the fiber mix as a drink and we will monitor changes in blood glucose levels. All participants will consume white bread as the control food.

Detailed description

There is some evidence for increased dietary fiber intake to positively impact on metabolic outcomes in patients with type 2 diabetes, potentially via modulating gut microbial composition and functions. We have developed a dietary fiber mix that is consisted of fiber of various physicochemical properties to maximize the fermentability of the supplement and thus its effects on the gut microbiota. Since the fiber mix also contains nutrients that will raise blood glucose levels, we need to characterize the glycemic response to the fiber mix itself, before we can use it in an upcoming trial to determine the effect of dietary fiber supplementation on the gut microbiota and glycemic control. Enrolled participants will be assigned to a subject group based on their diagnosis of type 2 diabetes and fasting blood glucose concentrations. Participants who are clinically diagnosed with impaired glucose tolerance or type 2 diabetes will be assigned to the Prediabetes/Diabetes group. For the other participants, those with fasting blood glucose \< 100 mg/dL will be assigned to the Non-Diabetes group, and those with fasting blood glucose \> 100 mg/dL will be assigned to the Prediabetes/Diabetes group. Participants will attend 8 food testing visits over 2 weeks. For each visit, participants will attend the research facility in the morning after an overnight fast. They will consume either white bread (with 50 g of available carbohydrates as a control food) or 60 g of the fiber mix (as a drink). Postprandial glycemic response will be assessed by changes in blood glucose levels, to be monitored using a continuous glucose monitoring system (FreeStyle Pro). A sensor will be placed on the participant's arm and will stay on until the end of the study. Participants will provide photos of all the food and drink and a brief description of what they have consumed throughout the 2-week study.

Conditions

• Type2 Diabetes Mellitus

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Fiber mix	Participants will test white bread or fiber mix over a span of 2 weeks. During each testing block, each food will be tested twice over two consecutive days. There are 4 testing blocks in total (one for white bread and three for fiber mix).

Timeline

• Start date: 2018-06-04
• Primary completion: 2019-02-01
• Completion: 2019-02-01
• First posted: 2017-11-07
• Last updated: 2019-04-04

Locations

1 site across 1 country: United States