Metabolic Effects of a Green Tea Extract in Multiple Sclerosis Patients

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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Key information

Conditions

Multiple Sclerosis, Relapsing-Remitting Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Nervous System Diseases

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Berlin, 13125, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Dietary Supplement

Daily intake of 600 mg EGCG for 3 months

Placebo

Dietary Supplement

Daily intake of placebo capsules for 3 months

Primary outcomes

Fasting and postprandial lipid oxidation in grams per hour, assessed by indirect calorimetry, after 3 months intake of green tea extract versus placebo

Time frame: Three months

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2013
First posted: Aug 16, 2011
Registry last updated: Jul 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed