Diabetes Mellitus, Type 2, Insulin Resistance
Conditions
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.
Interventions
DIETARY_SUPPLEMENTCarrageenan
Carrageenan 250 mg bid supplemented to a standard food
DIETARY_SUPPLEMENTPlacebo
Placebo (Mannitol/Aerosil) bid supplemented to a standard food
Sponsors
University Hospital Tuebingen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insulin sensitivity assessed by oral glucose tolerance test (OGTT): Matsuda index | 2 weeks |
| Insulin sensitivity assessed by hyperinsulinemic clamp: M-value | 2 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Cerebral insulin sensitivity measured by MRI | 2 weeks |
| Endogenous glucose production measured by tracer-method | 2 weeks |
| Intrahepatic triglyceride content | 2 weeks |
| Glycemia during OGTT | 2 weeks |
Other
| Measure | Time frame |
|---|---|
| Intestinal microbiome constitution | 2 weeks |
| Intestinal permeability | 2 weeks |
| Markers of systemic inflammation including lymphocyte activation, cytokines and adipokines | 2 weeks |
Countries
Germany
Outcome results
None listed