Impact of No-carrageenan Diet on Glucose Tolerance in Prediabetes

NCT ID: NCT02720393

Last Updated: 2019-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Prediabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

Regular Diet

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

No-carrageenan diet

Intervention Type OTHER

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

Interventions

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No-carrageenan diet

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

Intervention Type OTHER

Regular Diet

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

Intervention Type OTHER

Other Intervention Names

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Carrageenan-containing diet

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Illinois at Chicago

OTHER

Sponsor Role lead

Responsible Party

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Joanne Kramer Tobacman

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Illinois at Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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2015-1255

Identifier Type: -

Identifier Source: org_study_id

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