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NCT01417312 Clinical Trial

Metabolic Effects of a Green Tea Extract in Multiple Sclerosis Patients

Multiple Sclerosis, Relapsing-Remitting Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01417312
Other study ID # MS_GTE
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 2011
Est. completion date January 2013

Study information
Verified date July 2021
Source Charite University, Berlin, Germany
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date January 2013
Est. primary completion date November 2012
Accepts healthy volunteers No
Gender All
Age group 20 Years to 60 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Capsules with 160 mg Teavigo (at least 94% EGCG)
Daily intake of 600 mg EGCG for 3 months
• Placebo
Daily intake of placebo capsules for 3 months

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

Sponsors (1)
Lead Sponsor Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Fasting and postprandial lipid oxidation in grams per hour, assessed by indirect calorimetry, after 3 months intake of green tea extract versus placebo Three months
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