Impact of No-carrageenan Diet on Glucose Tolerance in Prediabetes
Impact of no Carrageenan Diet on Glucose Tolerance in Prediabetes
1 other identifier
interventional
48
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 9, 2016
CompletedFirst Posted
Study publicly available on registry
March 25, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedSeptember 30, 2019
September 1, 2019
2.8 years
February 9, 2016
September 26, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Change in hemoglobin A1c
Measurements performed after 12 weeks of dietary intervention
baseline, 12 weeks
Secondary Outcomes (6)
Change in serum Interleukin-8
baseline, 12 weeks
Impact on glucose tolerance test
12 weeks
Impact on insulin level
12 weeks
Change in leukocyte subsets
baseline, 12 weeks
Change in Tumor Necrosis Factor-alpha in serum
baseline, 12 weeks
- +1 more secondary outcomes
Other Outcomes (2)
Change in fecal microbiome
baseline, 12 weeks
Change in fecal calprotectin
baseline, 12 weeks
Study Arms (2)
Regular diet
PLACEBO COMPARATORMeals 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
EXPERIMENTALNo-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.
Interventions
Diet of food items that have no carrageenan as selected by study dietician.
Diet of food items that have carrageenan as selected by study dietician
Eligibility Criteria
You may qualify if:
- per diabetes, ability to follow diet and study procedures
You may not qualify if:
- on any medications that affect glucose, medical conditions or allergies that affect adherence to study diet, pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Illinois at Chicago
Chicago, Illinois, 60612, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
February 9, 2016
First Posted
March 25, 2016
Study Start
February 1, 2016
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
September 30, 2019
Record last verified: 2019-09