Fiber Mix and Glycemic Response

NCT03334643 | Completed

• 1 other identifier: 18-074m
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Type2 Diabetes Mellitus

Keywords

Type 2 Diabetes; Dietary fiber; Glycemic response

Outcome Measures

Primary Outcomes (1)

• Postprandial glycemic response

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

  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

Study Arms (2)

Non-Diabetes

EXPERIMENTAL

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.

Dietary Supplement: Fiber mix

Prediabetes/Diabetes

EXPERIMENTAL

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.

Dietary Supplement: Fiber mix

Interventions

Fiber mix DIETARY_SUPPLEMENT

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).

Non-Diabetes; Prediabetes/Diabetes

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 18 and 65 years
• Understand and be able to follow written and oral instructions in English
• Provide written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Institute for Food, Nutrition & Health

New Brunswick, New Jersey, 08901, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Liping Zhao, PhD

  Rutgers University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: November 3, 2017
• First Posted: November 7, 2017
• Study Start: June 4, 2018
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: April 4, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)