Impact of No-carrageenan Diet on Glucose Tolerance in Prediabetes

University of Illinois

Status: Completed

Conditions: Prediabetes

Treatments: Other: Regular Diet; Other: No-carrageenan diet

Study type: Interventional

Funder types: Other

Identifiers

NCT02720393

2015-1255

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 2 patient groups, including a placebo group

Regular diet

Placebo Comparator group

Description:

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.

Treatment:

Other: Regular Diet

No-carrageenan diet

Experimental group

Description:

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.

Treatment:

Other: No-carrageenan diet