Diabetes Mellitus, Type 2NCT02629705
Study of Carrageenan's Effect on Insulin Resistance in Humans
A study testing Carrageenan in people with Diabetes Mellitus, Type 2 and Insulin Resistance, run by University Hospital Tuebingen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Insulin Resistance
- What is being tested?
- Carrageenan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2015to Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- body mass index (BMI) 18.5 - 29.9 kg/m²
Who cannot join
- any chronic illness
- any ongoing medication
- known infections
- known liver disease
- known renal insufficiency
- alcohol consumption over 30 g/d
- shift work
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Tübingen, Department of Internal Medicine
Tübingen, 72076
About this study
Official title: 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.
- Conditions
- Diabetes Mellitus, Type 2, Insulin Resistance
- Being tested
- Carrageenan, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarrageenanDietary supplement
Also called E407
Carrageenan 250 mg bid supplemented to a standard food
PlaceboDietary supplement
Placebo (Mannitol/Aerosil) bid supplemented to a standard food
| Study group | Role | What they receive |
|---|---|---|
| Group A | Other | 1. Placebo intervention
2. Assessment block (3 days)
3. Washout-phase of 21-35 days
4. Carrageenan intervention
5. Assessment block (3 days) Receives: Dietary Supplement: Carrageenan; Dietary Supplement: Placebo |
| Group B | Other | 1. Carrageenan intervention
2. Assessment block (3 days)
3. Washout-phase of 21-35 days
4. Placebo intervention
5. Assessment block (3 days) Receives: Dietary Supplement: Carrageenan; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity assessed by oral glucose tolerance test (OGTT): Matsuda index
Measured: 2 weeks
Insulin sensitivity assessed by hyperinsulinemic clamp: M-value
Measured: 2 weeks
Secondary outcomes (4)
Endogenous glucose production measured by tracer-method
Measured: 2 weeks
Cerebral insulin sensitivity measured by MRI
Measured: 2 weeks
Intrahepatic triglyceride content
Measured: 2 weeks
Glycemia during OGTT
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2015 (estimated)
- Study startOct 2015
- Primary completion23 Dec 2016
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Wagner, M.D, Principal investigator, University of Tübingen, Department of Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02629705
- Sponsor's protocol ID
- CGN
- Status last verified
- Feb 2017
- First submitted
- 4 Dec 2015
- Last updated
- 18 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 39593091
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Carrageenan as Food Additive on Insulin Resistance in Humans
- ClinicalTrials.gov ID
- NCT02629705
- Acronym / sponsor ID
- CGN
- Conditions
- Diabetes Mellitus, Type 2, Insulin Resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- 23 Dec 2016 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 14 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Other | Dietary Supplement: Carrageenan, Dietary Supplement: Placebo1. Placebo intervention 2. Assessment block (3 days) 3. Washout-phase of 21-35 days 4. Carrageenan intervention 5. Assessment block (3 days) |
| Group B | Other | Dietary Supplement: Carrageenan, Dietary Supplement: Placebo1. Carrageenan intervention 2. Assessment block (3 days) 3. Washout-phase of 21-35 days 4. Placebo intervention 5. Assessment block (3 days) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- body mass index (BMI) 18.5 - 29.9 kg/m²
Key exclusion criteria (7 listed)
- any chronic illness
- any ongoing medication
- known infections
- known liver disease
- known renal insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CarrageenanAlso: E407Carrageenan 250 mg bid supplemented to a standard food | Dietary supplement | Group A, Group B |
| PlaceboPlacebo (Mannitol/Aerosil) bid supplemented to a standard food | Dietary supplement | Group A, Group B |
Primary outcome
Insulin sensitivity assessed by oral glucose tolerance test (OGTT): Matsuda index
Time frame: 2 weeks
Insulin sensitivity assessed by hyperinsulinemic clamp: M-value
Time frame: 2 weeks
4 secondary outcomes
Endogenous glucose production measured by tracer-method
Time frame: 2 weeks
Cerebral insulin sensitivity measured by MRI
Time frame: 2 weeks
Intrahepatic triglyceride content
Time frame: 2 weeks
Glycemia during OGTT
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2018.
- Derived from this study: PubMed 39593091Wagner 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.
Related trials for Diabetes Mellitus, Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Wagner, M.D principal investigator
University of Tübingen, Department of Internal Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carrageenan in people with Diabetes Mellitus, Type 2 and Insulin Resistance, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin sensitivity assessed by oral glucose tolerance test (OGTT): Matsuda index (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02629705, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2018.