Study of Carrageenan's Effect on Insulin Resistance in Humans

October 17, 2018 updated by: University Hospital Tuebingen

Investigation of the Effect of Carrageenan as Food Additive on Insulin Resistance in Humans

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Tübingen, Germany, 72076
        • University Hospital Tübingen, Department of Internal Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Group A
  1. Placebo intervention
  2. Assessment block (3 days)
  3. Washout-phase of 21-35 days
  4. Carrageenan intervention
  5. Assessment block (3 days)
Dietary supplement: Carrageenan
Carrageenan 250 mg bid supplemented to a standard food
Other Names:
  • E407
Dietary supplement: Placebo
Placebo (Mannitol/Aerosil) bid supplemented to a standard food
Other: Group B
  1. Carrageenan intervention
  2. Assessment block (3 days)
  3. Washout-phase of 21-35 days
  4. Placebo intervention
  5. Assessment block (3 days)
Dietary supplement: Carrageenan
Carrageenan 250 mg bid supplemented to a standard food
Other Names:
  • E407
Dietary supplement: Placebo
Placebo (Mannitol/Aerosil) bid supplemented to a standard food

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Endogenous glucose production measured by tracer-method
Time Frame: 2 weeks
2 weeks
Cerebral insulin sensitivity measured by MRI
Time Frame: 2 weeks
2 weeks
Intrahepatic triglyceride content
Time Frame: 2 weeks
2 weeks
Glycemia during OGTT
Time Frame: 2 weeks
2 weeks

Other Outcome Measures

Outcome Measure
Time Frame
Intestinal permeability
Time Frame: 2 weeks
2 weeks
Intestinal microbiome constitution
Time Frame: 2 weeks
2 weeks
Markers of systemic inflammation including lymphocyte activation, cytokines and adipokines
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Investigators

  • Principal Investigator: Robert Wagner, M.D, University of Tübingen, Department of Internal Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

December 23, 2016

Study Completion (Actual)

February 1, 2018

Study Registration Dates

First Submitted

December 4, 2015

First Submitted That Met QC Criteria

December 9, 2015

First Posted (Estimate)

December 14, 2015

Study Record Updates

Last Update Posted (Actual)

October 18, 2018

Last Update Submitted That Met QC Criteria

October 17, 2018

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CGN

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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