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Metabolic Effects of a Green Tea Extract in Multiple Sclerosis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01417312
Recruitment Status : Completed
First Posted : August 16, 2011
Last Update Posted : April 15, 2020
Sponsor:
Information provided by (Responsible Party):
Friedemann Paul, Charite University, Berlin, Germany

Brief 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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis, Relapsing-Remitting Dietary Supplement: Capsules with 160 mg Teavigo (at least 94% EGCG) Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Study Start Date : July 2011
Actual Primary Completion Date : November 2012
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01417312


Locations
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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
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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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Friedemann Paul, Prof, MD, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01417312    
Other Study ID Numbers: MS_GTE
First Posted: August 16, 2011    Key Record Dates
Last Update Posted: April 15, 2020
Last Verified: April 2020
Keywords provided by Friedemann Paul, Charite University, Berlin, Germany:
Multiple sclerosis
Green tea extract
Metabolism
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases