Metabolic Effects of a Green Tea Extract in Multiple Sclerosis Patients

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

2011-07-31

Study Completion Date

2013-01-31

Brief Summary

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This study aims to investigate metabolic effects of a standardized green tea extract, containing a defined amount of epigallocatechin-3-gallate (EGCG), in multiple sclerosis patients.

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Detailed Description

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Conditions

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Multiple Sclerosis, Relapsing-Remitting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Green tea extract

Group Type ACTIVE_COMPARATOR

Capsules with 160 mg Teavigo (at least 94% EGCG)

Intervention Type DIETARY_SUPPLEMENT

Daily intake of 600 mg EGCG for 3 months

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Daily intake of placebo capsules for 3 months

Interventions

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Capsules with 160 mg Teavigo (at least 94% EGCG)

Daily intake of 600 mg EGCG for 3 months

Intervention Type DIETARY_SUPPLEMENT

Placebo

Daily intake of placebo capsules for 3 months

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Patients with relapsing-remitting multiple sclerosis
* stable treatment with glatiramer acetate at least 6 months prior to inclusion
* Expanded disability status scale \< 4.5
* Normal weight, overweight

Exclusion Criteria

* Primary or secondary progressive forms of multiple sclerosis
* Clinically relevant heart, lung, liver, kidney diseases
* Habitual caffeine intake over 300 mg per day
* Habitual consumption of green tea
* Alcohol or drug abuse

Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Friedemann Paul

Prof, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Friedemann Paul, Prof, MD

Role: PRINCIPAL_INVESTIGATOR

NeuroCure Clinical Research Center and Experimental and Clinical Research Center, Charité University Medicine Berlin and Max Delbrueck Center for Molecular Medicine, Berlin, Germany

Michael Boschmann, MD

Role: PRINCIPAL_INVESTIGATOR

Franz-Volhard Clinical Research Center at the Experimental and Clinical Research Center, Charité University Medicine and Max Delbrueck Center for Molecular Medicine, Berlin, Germany