Back to resultsImpact of No-carrageenan Diet on Glucose Tolerance in Prediabetes
Primary Purpose
Prediabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
No-carrageenan diet
Regular Diet
Sponsored by
About this trial
This is an interventional prevention trial for Prediabetes
Eligibility Criteria
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
Sites / Locations
- University of Illinois at Chicago
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Regular diet
No-carrageenan diet
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change in hemoglobin A1c
Measurements performed after 12 weeks of dietary intervention
Secondary Outcome Measures
Change in serum Interleukin-8
Impact of diet on serum Interleukin-8
Impact on glucose tolerance test
perform repeat oral glucose tolerance test after 12 weeks of dietary intervention
Impact on insulin level
determine effect of dietary intervention on insulin level at the time of glucose tolerance test
Change in leukocyte subsets
determine if there is change in distribution of leukocyte subsets from blood samples of study participants
Change in Tumor Necrosis Factor-alpha in serum
determine if there is change in circulating TNF-alpha in blood samples
Change in insulin signaling pathway
determine if there are changes in activation of intermediates in insulin signaling pathway in circulating leukocytes following dietary intervention
Full Information
NCT ID
NCT02720393
First Posted
February 9, 2016
Last Updated
September 26, 2019
Sponsor
University of Illinois at Chicago
1. Study Identification
Unique Protocol Identification Number
NCT02720393
Brief Title
Impact of No-carrageenan Diet on Glucose Tolerance in Prediabetes
Official Title
Impact of no Carrageenan Diet on Glucose Tolerance in Prediabetes
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prediabetes
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Regular diet
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
No-carrageenan diet
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
No-carrageenan diet
Intervention Description
Diet of food items that have no carrageenan as selected by study dietician.
Intervention Type
Other
Intervention Name(s)
Regular Diet
Other Intervention Name(s)
Carrageenan-containing diet
Intervention Description
Diet of food items that have carrageenan as selected by study dietician
Primary Outcome Measure Information:
Title
Change in hemoglobin A1c
Description
Measurements performed after 12 weeks of dietary intervention
Time Frame
baseline, 12 weeks
Secondary Outcome Measure Information:
Title
Change in serum Interleukin-8
Description
Impact of diet on serum Interleukin-8
Time Frame
baseline, 12 weeks
Title
Impact on glucose tolerance test
Description
perform repeat oral glucose tolerance test after 12 weeks of dietary intervention
Time Frame
12 weeks
Title
Impact on insulin level
Description
determine effect of dietary intervention on insulin level at the time of glucose tolerance test
Time Frame
12 weeks
Title
Change in leukocyte subsets
Description
determine if there is change in distribution of leukocyte subsets from blood samples of study participants
Time Frame
baseline, 12 weeks
Title
Change in Tumor Necrosis Factor-alpha in serum
Description
determine if there is change in circulating TNF-alpha in blood samples
Time Frame
baseline, 12 weeks
Title
Change in insulin signaling pathway
Description
determine if there are changes in activation of intermediates in insulin signaling pathway in circulating leukocytes following dietary intervention
Time Frame
baseline, 12 weeks
Other Pre-specified Outcome Measures:
Title
Change in fecal microbiome
Description
Impact of diet on fecal microbiome following dietary intervention determined by whole genome sequencing of fecal bacteria
Time Frame
baseline, 12 weeks
Title
Change in fecal calprotectin
Description
determine effect of dietary intervention on fecal calprotectin
Time Frame
baseline, 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
If required, individual data without identifiers may be made available.
Learn more about this trial
Impact of No-carrageenan Diet on Glucose Tolerance in Prediabetes
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