Study of Carrageenan's Effect on Insulin Resistance in Humans
Investigation of the Effect of Carrageenan as Food Additive on Insulin Resistance in Humans
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable diabetes-mellitus-type-2
Started Oct 2015
Typical duration for not_applicable diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 4, 2015
CompletedFirst Posted
Study publicly available on registry
December 14, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 23, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2018
CompletedOctober 18, 2018
February 1, 2017
1.2 years
December 4, 2015
October 17, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Insulin sensitivity assessed by oral glucose tolerance test (OGTT): Matsuda index
2 weeks
Insulin sensitivity assessed by hyperinsulinemic clamp: M-value
2 weeks
Secondary Outcomes (4)
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
Other Outcomes (3)
Intestinal permeability
2 weeks
Intestinal microbiome constitution
2 weeks
Markers of systemic inflammation including lymphocyte activation, cytokines and adipokines
2 weeks
Study Arms (2)
Group A
OTHER1. Placebo intervention 2. Assessment block (3 days) 3. Washout-phase of 21-35 days 4. Carrageenan intervention 5. Assessment block (3 days)
Group B
OTHER1. Carrageenan intervention 2. Assessment block (3 days) 3. Washout-phase of 21-35 days 4. Placebo intervention 5. Assessment block (3 days)
Interventions
Carrageenan 250 mg bid supplemented to a standard food
Placebo (Mannitol/Aerosil) bid supplemented to a standard food
Eligibility Criteria
You may qualify if:
- body mass index (BMI) 18.5 - 29.9 kg/m²
You may not qualify if:
- any chronic illness
- any ongoing medication
- known infections
- known liver disease
- known renal insufficiency
- alcohol consumption over 30 g/d
- shift work
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Tübingen, Department of Internal Medicine
Tübingen, 72076, Germany
Related Publications (1)
Wagner R, Buettner J, Heni M, Fritsche L, Kullmann S, Wagmuller M, Peter A, Preissl H, Machann J, Jumpertz von Schwartzenberg R, Birkenfeld AL, Pape UF, van Hall G, Plomgaard P, Haring HU, Fritsche A, Thompson KN, Klein R, Stefan N. Carrageenan and insulin resistance in humans: a randomised double-blind cross-over trial. BMC Med. 2024 Nov 26;22(1):558. doi: 10.1186/s12916-024-03771-8.
PMID: 39593091DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Wagner, M.D
University of Tübingen, Department of Internal Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 4, 2015
First Posted
December 14, 2015
Study Start
October 1, 2015
Primary Completion
December 23, 2016
Study Completion
February 1, 2018
Last Updated
October 18, 2018
Record last verified: 2017-02