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Metabolic Effects of a Green Tea Extract in Multiple Sclerosis Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Friedemann Paul, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01417312
First received: August 15, 2011
Last updated: January 17, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Multiple Sclerosis, Relapsing-Remitting
 Dietary Supplement: Capsules with 160 mg Teavigo (at least 94% EGCG)
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: July 2011
Study Completion Date: January 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Green tea extract Dietary Supplement: Capsules with 160 mg Teavigo (at least 94% EGCG)
Daily intake of 600 mg EGCG for 3 months
Placebo Comparator: Placebo Dietary Supplement: Placebo
Daily intake of placebo capsules for 3 months

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01417312

Locations
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, Germany, 13125
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Friedemann Paul, Prof, MD NeuroCure Clinical Research Center and Experimental and Clinical Research Center, Charité University Medicine Berlin and Max Delbrueck Center for Molecular Medicine, Berlin, Germany
Principal Investigator: Michael Boschmann, MD Franz-Volhard Clinical Research Center at the Experimental and Clinical Research Center, Charité University Medicine and Max Delbrueck Center for Molecular Medicine, Berlin, Germany
  More Information

No publications provided

Responsible Party: Friedemann Paul, Prof, MD, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01417312     History of Changes
Other Study ID Numbers: MS_GTE
Study First Received: August 15, 2011
Last Updated: January 17, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:
Multiple sclerosis
Green tea extract
Metabolism

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013