Study of Carrageenan's Effect on Insulin Resistance in Humans

University Hospital Tuebingen20 enrolled

Overview

The purpose of this study is to determine whether the ingestion of the common food additive carrageenan contributes to insulin resistance and thus to the pathogenesis of type 2 diabetes in humans.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Diabetes Mellitus, Type 2 Insulin Resistance

Interventions

CarrageenanDIETARY_SUPPLEMENT

Carrageenan 250 mg bid supplemented to a standard food

PlaceboDIETARY_SUPPLEMENT

Placebo (Mannitol/Aerosil) bid supplemented to a standard food

Eligibility

Sex: MALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * body mass index (BMI) 18.5 - 29.9 kg/m² Exclusion Criteria: * any chronic illness * any ongoing medication * known infections * known liver disease * known renal insufficiency * alcohol consumption over 30 g/d * shift work

Locations (1)

University Hospital Tübingen, Department of Internal Medicine

Tübingen, Germany

Outcomes

Primary Outcomes

Insulin sensitivity assessed by oral glucose tolerance test (OGTT): Matsuda index

Time frame: 2 weeks

Insulin sensitivity assessed by hyperinsulinemic clamp: M-value

Time frame: 2 weeks

Secondary Outcomes

Endogenous glucose production measured by tracer-method

Time frame: 2 weeks

Cerebral insulin sensitivity measured by MRI

Time frame: 2 weeks

Intrahepatic triglyceride content

Time frame: 2 weeks

Glycemia during OGTT

Time frame: 2 weeks

Data from ClinicalTrials.gov

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