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Metabolic Effects of a Green Tea Extract in Multiple Sclerosis Patients

Primary Purpose

Multiple Sclerosis, Relapsing-Remitting

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Capsules with 160 mg Teavigo (at least 94% EGCG)
Placebo
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Multiple Sclerosis, Relapsing-Remitting focused on measuring Multiple sclerosis, Green tea extract, Metabolism

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Green tea extract

Placebo

Arm Description

Outcomes

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

Secondary Outcome Measures

Full Information

First Posted
August 15, 2011
Last Updated
July 28, 2021
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT01417312
Brief Title
Metabolic Effects of a Green Tea Extract in Multiple Sclerosis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Relapsing-Remitting
Keywords
Multiple sclerosis, Green tea extract, Metabolism

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Green tea extract
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Capsules with 160 mg Teavigo (at least 94% EGCG)
Intervention Description
Daily intake of 600 mg EGCG for 3 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Daily intake of placebo capsules for 3 months
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Friedemann Paul, Prof, MD
Organizational Affiliation
NeuroCure Clinical Research Center and Experimental and Clinical Research Center, Charité University Medicine Berlin and Max Delbrueck Center for Molecular Medicine, Berlin, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Boschmann, MD
Organizational Affiliation
Franz-Volhard Clinical Research Center at the Experimental and Clinical Research Center, Charité University Medicine and Max Delbrueck Center for Molecular Medicine, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Franz-Volhard Clinical Research Center at the Experimental and Clinical Research Center, Charité University Medicine Berlin and Max Delbrueck Center for Molecular Medicine
City
Berlin
ZIP/Postal Code
13125
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
25733633
Citation
Mahler A, Steiniger J, Bock M, Klug L, Parreidt N, Lorenz M, Zimmermann BF, Krannich A, Paul F, Boschmann M. Metabolic response to epigallocatechin-3-gallate in relapsing-remitting multiple sclerosis: a randomized clinical trial. Am J Clin Nutr. 2015 Mar;101(3):487-95. doi: 10.3945/ajcn.113.075309. Epub 2015 Jan 14.
Results Reference
derived

Learn more about this trial

Metabolic Effects of a Green Tea Extract in Multiple Sclerosis Patients

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