Impact of No-carrageenan Diet on Glucose Tolerance in Prediabetes

Impact of no Carrageenan Diet on Glucose Tolerance in Prediabetes

Participants will be randomly assigned to either regular or no-carrageenan prepared diets to determine whether the no-carrageenan leads to improvement in glucose tolerance. Hemoglobin A1c is the primary outcome measure.

Study Overview

• Status: Completed
• Conditions: Prediabetes
• Intervention / Treatment: Other: Regular Diet; Other: No-carrageenan diet

Detailed Description

Subjects will be randomly assigned to a diet. They will at onset have hemoglobin A1c values between 5.7% and 6.4%. Baseline glucose tolerance test will be performed, as well as measures of inflammation and fecal microbiome. Interim tests will be performed at six weeks. Subjects will participate for 12 weeks, at which time they will be re-evaluated.

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois at Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• per diabetes, ability to follow diet and study procedures

Exclusion Criteria:

• on any medications that affect glucose, medical conditions or allergies that affect adherence to study diet, pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Regular diet; Meals and snacks will contain carrageenan in the amount consumed in the typical daily diet and will be selected by the study dietician and distributed to study subjects randomized to the regular diet study arm.	Other: Regular Diet; Diet of food items that have carrageenan as selected by study dietician; Other Names: Carrageenan-containing diet
Experimental: No-carrageenan diet; No-carrageenan diet will be composed of meals and snacks selected by the study dietician and distributed to study participants who are randomized to the no-carrageenan diet study arm.	Other: No-carrageenan diet; Diet of food items that have no carrageenan as selected by study dietician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in hemoglobin A1c	Measurements performed after 12 weeks of dietary intervention	baseline, 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in serum Interleukin-8	Impact of diet on serum Interleukin-8	baseline, 12 weeks
Impact on glucose tolerance test	perform repeat oral glucose tolerance test after 12 weeks of dietary intervention	12 weeks
Impact on insulin level	determine effect of dietary intervention on insulin level at the time of glucose tolerance test	12 weeks
Change in leukocyte subsets	determine if there is change in distribution of leukocyte subsets from blood samples of study participants	baseline, 12 weeks
Change in Tumor Necrosis Factor-alpha in serum	determine if there is change in circulating TNF-alpha in blood samples	baseline, 12 weeks
Change in insulin signaling pathway	determine if there are changes in activation of intermediates in insulin signaling pathway in circulating leukocytes following dietary intervention	baseline, 12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in fecal microbiome	Impact of diet on fecal microbiome following dietary intervention determined by whole genome sequencing of fecal bacteria	baseline, 12 weeks
Change in fecal calprotectin	determine effect of dietary intervention on fecal calprotectin	baseline, 12 weeks

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: February 9, 2016
• First Submitted That Met QC Criteria: March 21, 2016
• First Posted (Estimate): March 25, 2016

Study Record Updates

• Last Update Posted (Actual): September 30, 2019
• Last Update Submitted That Met QC Criteria: September 26, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Hyperglycemia; Prediabetic State; Glucose Intolerance
• Other Study ID Numbers: 2015-1255

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: If required, individual data without identifiers may be made available.