Study of Carrageenan's Effect on Insulin Resistance in Humans

NCT ID: NCT02629705

Last Updated: 2018-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2018-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2 Insulin Resistance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group A

1. Placebo intervention
2. Assessment block (3 days)
3. Washout-phase of 21-35 days
4. Carrageenan intervention
5. Assessment block (3 days)

Group Type OTHER

Carrageenan

Intervention Type DIETARY_SUPPLEMENT

Carrageenan 250 mg bid supplemented to a standard food

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Group B

1. Carrageenan intervention
2. Assessment block (3 days)
3. Washout-phase of 21-35 days
4. Placebo intervention
5. Assessment block (3 days)

Group Type OTHER

Carrageenan

Intervention Type DIETARY_SUPPLEMENT

Carrageenan 250 mg bid supplemented to a standard food

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Carrageenan

Carrageenan 250 mg bid supplemented to a standard food

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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E407

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Wagner, M.D

Role: PRINCIPAL_INVESTIGATOR

University of Tübingen, Department of Internal Medicine

Locations

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University Hospital Tübingen, Department of Internal Medicine

Tübingen, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 39593091 (View on PubMed)

Other Identifiers

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CGN

Identifier Type: -

Identifier Source: org_study_id

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