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Study of Carrageenan's Effect on Insulin Resistance in Humans

Primary Purpose

Diabetes Mellitus, Type 2, Insulin Resistance

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Carrageenan
Placebo
Sponsored by
University Hospital Tuebingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • University Hospital Tübingen, Department of Internal Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Group A

Group B

Arm Description

Placebo intervention Assessment block (3 days) Washout-phase of 21-35 days Carrageenan intervention Assessment block (3 days)

Carrageenan intervention Assessment block (3 days) Washout-phase of 21-35 days Placebo intervention Assessment block (3 days)

Outcomes

Primary Outcome Measures

Insulin sensitivity assessed by oral glucose tolerance test (OGTT): Matsuda index
Insulin sensitivity assessed by hyperinsulinemic clamp: M-value

Secondary Outcome Measures

Endogenous glucose production measured by tracer-method
Cerebral insulin sensitivity measured by MRI
Intrahepatic triglyceride content
Glycemia during OGTT

Full Information

First Posted
December 4, 2015
Last Updated
October 17, 2018
Sponsor
University Hospital Tuebingen
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1. Study Identification

Unique Protocol Identification Number
NCT02629705
Brief Title
Study of Carrageenan's Effect on Insulin Resistance in Humans
Official Title
Investigation of the Effect of Carrageenan as Food Additive on Insulin Resistance in Humans
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
December 23, 2016 (Actual)
Study Completion Date
February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Tuebingen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Insulin Resistance

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Other
Arm Description
Placebo intervention Assessment block (3 days) Washout-phase of 21-35 days Carrageenan intervention Assessment block (3 days)
Arm Title
Group B
Arm Type
Other
Arm Description
Carrageenan intervention Assessment block (3 days) Washout-phase of 21-35 days Placebo intervention Assessment block (3 days)
Intervention Type
Dietary Supplement
Intervention Name(s)
Carrageenan
Other Intervention Name(s)
E407
Intervention Description
Carrageenan 250 mg bid supplemented to a standard food
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo (Mannitol/Aerosil) bid supplemented to a standard food
Primary Outcome Measure Information:
Title
Insulin sensitivity assessed by oral glucose tolerance test (OGTT): Matsuda index
Time Frame
2 weeks
Title
Insulin sensitivity assessed by hyperinsulinemic clamp: M-value
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Endogenous glucose production measured by tracer-method
Time Frame
2 weeks
Title
Cerebral insulin sensitivity measured by MRI
Time Frame
2 weeks
Title
Intrahepatic triglyceride content
Time Frame
2 weeks
Title
Glycemia during OGTT
Time Frame
2 weeks
Other Pre-specified Outcome Measures:
Title
Intestinal permeability
Time Frame
2 weeks
Title
Intestinal microbiome constitution
Time Frame
2 weeks
Title
Markers of systemic inflammation including lymphocyte activation, cytokines and adipokines
Time Frame
2 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Wagner, M.D
Organizational Affiliation
University of Tübingen, Department of Internal Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Tübingen, Department of Internal Medicine
City
Tübingen
ZIP/Postal Code
72076
Country
Germany

12. IPD Sharing Statement

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Study of Carrageenan's Effect on Insulin Resistance in Humans

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