Impact of No-carrageenan Diet on Glucose Tolerance in Prediabetes

Prediabetes Clinical Trial

Official title:

Impact of no Carrageenan Diet on Glucose Tolerance in Prediabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02720393
• Other study ID #: 2015-1255
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: December 2018

Study information

• Verified date: September 2019
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glucose Intolerance
• Prediabetes
• Prediabetic State

Intervention

Other:
• No-carrageenan diet
Diet of food items that have no carrageenan as selected by study dietician.
• Regular Diet
Diet of food items that have carrageenan as selected by study dietician

Locations

Country	Name	City	State
United States	University of Illinois at Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in fecal microbiome	Impact of diet on fecal microbiome following dietary intervention determined by whole genome sequencing of fecal bacteria	baseline, 12 weeks
Other	Change in fecal calprotectin	determine effect of dietary intervention on fecal calprotectin	baseline, 12 weeks
Primary	Change in hemoglobin A1c	Measurements performed after 12 weeks of dietary intervention	baseline, 12 weeks
Secondary	Change in serum Interleukin-8	Impact of diet on serum Interleukin-8	baseline, 12 weeks
Secondary	Impact on glucose tolerance test	perform repeat oral glucose tolerance test after 12 weeks of dietary intervention	12 weeks
Secondary	Impact on insulin level	determine effect of dietary intervention on insulin level at the time of glucose tolerance test	12 weeks
Secondary	Change in leukocyte subsets	determine if there is change in distribution of leukocyte subsets from blood samples of study participants	baseline, 12 weeks
Secondary	Change in Tumor Necrosis Factor-alpha in serum	determine if there is change in circulating TNF-alpha in blood samples	baseline, 12 weeks
Secondary	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