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Completed

NCT Number: NCT02629705

Study of Carrageenan's Effect 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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Tübingen, Department of Internal Medicine

Tübingen, 72076, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Carrageenan

Dietary Supplement

Carrageenan 250 mg bid supplemented to a standard food

Other names: E407

Placebo

Dietary Supplement

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

Primary outcomes

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

    Time frame: 2 weeks

  2. Insulin sensitivity assessed by hyperinsulinemic clamp: M-value

    Time frame: 2 weeks

Secondary outcomes

  1. Endogenous glucose production measured by tracer-method

    Time frame: 2 weeks

  2. Cerebral insulin sensitivity measured by MRI

    Time frame: 2 weeks

  3. Intrahepatic triglyceride content

    Time frame: 2 weeks

  4. Glycemia during OGTT

    Time frame: 2 weeks

Other outcomes

  1. Intestinal permeability

    Time frame: 2 weeks

  2. Intestinal microbiome constitution

    Time frame: 2 weeks

  3. Markers of systemic inflammation including lymphocyte activation, cytokines and adipokines

    Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2018
First posted
Dec 14, 2015
Registry last updated
Oct 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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