NCT01417312

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 16, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

July 29, 2021

Status Verified

July 1, 2021

Enrollment Period

1.3 years

First QC Date

August 15, 2011

Last Update Submit

July 28, 2021

Conditions

Multiple Sclerosis, Relapsing-Remitting

Keywords

Multiple sclerosisGreen tea extractMetabolism

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Green tea extract

ACTIVE COMPARATOR
Dietary Supplement: Capsules with 160 mg Teavigo (at least 94% EGCG)

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

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

Daily intake of 600 mg EGCG for 3 months

Green tea extract
PlaceboDIETARY_SUPPLEMENT

Daily intake of placebo capsules for 3 months

Placebo

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with relapsing-remitting multiple sclerosis
  • Expanded disability status scale \< 4.5
  • Normal weight, overweight

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Location

Related Publications (1)

  • 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.

    PMID: 25733633DERIVED

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-RemittingMultiple Sclerosis

Interventions

epigallocatechin gallate

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof, MD

Study Record Dates

First Submitted

August 15, 2011

First Posted

August 16, 2011

Study Start

July 1, 2011

Primary Completion

November 1, 2012

Study Completion

January 1, 2013

Last Updated

July 29, 2021

Record last verified: 2021-07

Locations

DE(1)