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Fiber Mix and Glycemic Response

Primary Purpose

Type2 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fiber mix
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type2 Diabetes Mellitus focused on measuring Type 2 Diabetes, Dietary fiber, Glycemic response

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Institute for Food, Nutrition & Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Non-Diabetes

Prediabetes/Diabetes

Arm Description

Participants without clinical diagnosis of impaired glucose tolerance or type 2 diabetes and with fasting blood glucose less than 100 mg/dL. They will consume white bread or fiber mix for multiple times over a span of 2 weeks. Changes in blood glucose levels will be monitored.

Participants who are clinically diagnosed with impaired glucose tolerance or type 2 diabetes, and those without the above diagnosis but with fasting blood glucose equal to or greater than 100 mg/dL. They will consume white bread or fiber mix for multiple times over a span of 2 weeks. Changes in blood glucose levels will be monitored.

Outcomes

Primary Outcome Measures

Postprandial glycemic response
Circulating blood glucose concentration will be measured using a continuous glucose monitoring system (FreeStyle Libre Pro, Abbott Diabetes Care)

Secondary Outcome Measures

Full Information

First Posted
November 3, 2017
Last Updated
April 2, 2019
Sponsor
Rutgers, The State University of New Jersey
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1. Study Identification

Unique Protocol Identification Number
NCT03334643
Brief Title
Fiber Mix and Glycemic Response
Official Title
The Effect of a Dietary Fiber Mix on Glycemic Response in Human: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
June 4, 2018 (Actual)
Primary Completion Date
February 1, 2019 (Actual)
Study Completion Date
February 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2 Diabetes Mellitus
Keywords
Type 2 Diabetes, Dietary fiber, Glycemic response

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be assigned to either the Non-Diabetes or Prediabetes/Diabetes group based on their diagnosis of type 2 diabetes (if any) and their fasting blood glucose concentrations.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non-Diabetes
Arm Type
Experimental
Arm Description
Participants without clinical diagnosis of impaired glucose tolerance or type 2 diabetes and with fasting blood glucose less than 100 mg/dL. They will consume white bread or fiber mix for multiple times over a span of 2 weeks. Changes in blood glucose levels will be monitored.
Arm Title
Prediabetes/Diabetes
Arm Type
Experimental
Arm Description
Participants who are clinically diagnosed with impaired glucose tolerance or type 2 diabetes, and those without the above diagnosis but with fasting blood glucose equal to or greater than 100 mg/dL. They will consume white bread or fiber mix for multiple times over a span of 2 weeks. Changes in blood glucose levels will be monitored.
Intervention Type
Dietary Supplement
Intervention Name(s)
Fiber mix
Intervention Description
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).
Primary Outcome Measure Information:
Title
Postprandial glycemic response
Description
Circulating blood glucose concentration will be measured using a continuous glucose monitoring system (FreeStyle Libre Pro, Abbott Diabetes Care)
Time Frame
The system will measure circulating blood glucose concentrations every 15 min continuously over 14 days. The data collected immediately prior to and up to 3 h after consuming the test food will be used to assess postprandial glycemic response

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liping Zhao, PhD
Organizational Affiliation
Rutgers University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Food, Nutrition & Health
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Fiber Mix and Glycemic Response

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