Impact of No-carrageenan Diet on Glucose Tolerance in Prediabetes

Not Applicable

Completed

• Conditions: Prediabetes
• Interventions: Other: No-carrageenan diet; Other: Regular Diet

• Registration Number: NCT02720393
• Lead Sponsor: University of Illinois at Chicago

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.

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-09
• Study First Submitted QC: 2016-03-21
• Study First Posted: 2016-03-25
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-26
• Last Update Posted: 2019-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No-carrageenan diet	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.
Regular diet	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.

Primary Outcome Measures

Name	Time	Method
Change in hemoglobin A1c	baseline, 12 weeks	Measurements performed after 12 weeks of dietary intervention

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Illinois at Chicago; 🇺🇸 Chicago, Illinois, United States