Study of Carrageenan's Effect on Insulin Resistance in Humans

Not Applicable

Completed

• Conditions: Insulin Resistance; Diabetes Mellitus, Type 2
• Interventions: Dietary Supplement: Carrageenan; Dietary Supplement: Placebo

• Registration Number: NCT02629705
• Lead Sponsor: University Hospital Tuebingen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-12-04
• Study First Submitted QC: 2015-12-09
• Study First Posted: 2015-12-14
• Primary Completion: 2016-12-23
• Status Verified: 2017-02
• Study Completion: 2018-02
• Last Update Submitted: 2018-10-17
• Last Update Posted: 2018-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group A	Carrageenan	1. Placebo intervention 2. Assessment block (3 days) 3. Washout-phase of 21-35 days 4. Carrageenan intervention 5. Assessment block (3 days)
Group A	Placebo	1. Placebo intervention 2. Assessment block (3 days) 3. Washout-phase of 21-35 days 4. Carrageenan intervention 5. Assessment block (3 days)
Group B	Placebo	1. Carrageenan intervention 2. Assessment block (3 days) 3. Washout-phase of 21-35 days 4. Placebo intervention 5. Assessment block (3 days)
Group B	Carrageenan	1. Carrageenan intervention 2. Assessment block (3 days) 3. Washout-phase of 21-35 days 4. Placebo intervention 5. Assessment block (3 days)

Primary Outcome Measures

Name	Time	Method
Insulin sensitivity assessed by oral glucose tolerance test (OGTT): Matsuda index	2 weeks
Insulin sensitivity assessed by hyperinsulinemic clamp: M-value	2 weeks

Secondary Outcome Measures

Name	Time	Method
Endogenous glucose production measured by tracer-method	2 weeks
Cerebral insulin sensitivity measured by MRI	2 weeks
Intrahepatic triglyceride content	2 weeks
Glycemia during OGTT	2 weeks

Trial Locations

Locations (1)

University Hospital Tübingen, Department of Internal Medicine; 🇩🇪 Tübingen, Germany