Fiber Mix and Glycemic Response



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 65
Updated:4/6/2019
Start Date:June 4, 2018
End Date:February 1, 2019

Use our guide to learn which trials are right for you!

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

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.

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.

Inclusion Criteria

- Aged between 18 and 65 years

- Understand and be able to follow written and oral instructions in English

- Provide written informed consent

Exclusion Criteria

- Receiving insulin for diabetes treatment

- Receiving injectable prescription medicine

- Self-reported allergy or intolerance to any ingredients in the test food

- Any conditions deemed by the investigators that would prevent participation in the
study, e.g. participation in past or active clinical research that may interfere with
study outcomes, at the discretion of the investigators

- Any conditions deemed by the investigators that would compromise the individual's
ability to complete the study, e.g. serious psychiatric conditions, at the discretion
of the investigators
We found this trial at
1
site
61 Dudley Road
New Brunswick, New Jersey 08901
Principal Investigator: Liping Zhao, PhD
Phone: 848-932-5673
?
mi
from
New Brunswick, NJ
Click here to add this to my saved trials