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OpenTrials
Completed

NCT Number: NCT02720393

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.

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Key information

Conditions

PreDiabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Prediabetic State

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No-carrageenan diet

Other

Diet of food items that have no carrageenan as selected by study dietician.

Regular Diet

Other

Diet of food items that have carrageenan as selected by study dietician

Other names: Carrageenan-containing diet

Primary outcomes

  1. Change in hemoglobin A1c

    Time frame: baseline, 12 weeks

    Measurements performed after 12 weeks of dietary intervention

Secondary outcomes

  1. Change in serum Interleukin-8

    Time frame: baseline, 12 weeks

    Impact of diet on serum Interleukin-8

  2. Impact on glucose tolerance test

    Time frame: 12 weeks

    perform repeat oral glucose tolerance test after 12 weeks of dietary intervention

  3. Impact on insulin level

    Time frame: 12 weeks

    determine effect of dietary intervention on insulin level at the time of glucose tolerance test

  4. Change in leukocyte subsets

    Time frame: baseline, 12 weeks

    determine if there is change in distribution of leukocyte subsets from blood samples of study participants

  5. Change in Tumor Necrosis Factor-alpha in serum

    Time frame: baseline, 12 weeks

    determine if there is change in circulating TNF-alpha in blood samples

  6. Change in insulin signaling pathway

    Time frame: baseline, 12 weeks

    determine if there are changes in activation of intermediates in insulin signaling pathway in circulating leukocytes following dietary intervention

Other outcomes

  1. Change in fecal microbiome

    Time frame: baseline, 12 weeks

    Impact of diet on fecal microbiome following dietary intervention determined by whole genome sequencing of fecal bacteria

  2. Change in fecal calprotectin

    Time frame: baseline, 12 weeks

    determine effect of dietary intervention on fecal calprotectin

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Registry information

Official study title

Impact of no Carrageenan Diet on Glucose Tolerance in Prediabetes

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 25, 2016
Registry last updated
Sep 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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