Multiple Sclerosis, Relapsing-RemittingNCT01417312
Metabolic Effects of a Green Tea Extract in Multiple Sclerosis Patients
A study testing Capsules with 160 mg Teavigo (at least 94% EGCG) in people with Multiple Sclerosis, Relapsing-Remitting, run by Charite University, Berlin, Germany at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- Capsules with 160 mg Teavigo (at least 94% EGCG)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2011to Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
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
About this study
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.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Being tested
- Capsules with 160 mg Teavigo (at least 94% EGCG), Placebo
- Keywords
- Multiple sclerosis, Green tea extract, Metabolism
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capsules with 160 mg Teavigo (at least 94% EGCG)Dietary supplement
Daily intake of 600 mg EGCG for 3 months
PlaceboDietary supplement
Daily intake of placebo capsules for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Green tea extract | Active comparator | Not described Receives: Dietary Supplement: Capsules with 160 mg Teavigo (at least 94% EGCG) |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting and postprandial lipid oxidation in grams per hour, assessed by indirect calorimetry, after 3 months intake of green tea extract versus placebo
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2011 (estimated)
- Study startJul 2011
- Primary completionNov 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Friedemann Paul, Charite University, Berlin, Germany
- Investigators
- Friedemann Paul, Prof, MD, Principal investigator, NeuroCure Clinical Research Center and Experimental and Clinical Research Center, Charité University Medicine Berlin and Max Delbrueck Center for Molecular Medicine, Berlin, GermanyMichael Boschmann, MD, Principal investigator, Franz-Volhard Clinical Research Center at the Experimental and Clinical Research Center, Charité University Medicine and Max Delbrueck Center for Molecular Medicine, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01417312
- Sponsor's protocol ID
- MS_GTE
- Status last verified
- Jul 2021
- First submitted
- 15 Aug 2011
- Last updated
- 29 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25733633
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Effects of a Green Tea Extract in Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT01417312
- Acronym / sponsor ID
- MS_GTE
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Keywords
- Multiple sclerosis, Green tea extract, Metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 16 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Green tea extract | Active comparator | Dietary Supplement: Capsules with 160 mg Teavigo (at least 94% EGCG) |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capsules with 160 mg Teavigo (at least 94% EGCG)Daily intake of 600 mg EGCG for 3 months | Dietary supplement | Green tea extract |
| PlaceboDaily intake of placebo capsules for 3 months | Dietary supplement | Placebo |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2021.
- Derived from this study: PubMed 25733633Mahler 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Friedemann Paul, Prof, MD principal investigator
NeuroCure Clinical Research Center and Experimental and Clinical Research Center, Charité University Medicine Berlin and Max Delbrueck Center for Molecular Medicine, Berlin, Germany
Michael Boschmann, MD principal investigator
Franz-Volhard Clinical Research Center at the Experimental and Clinical Research Center, Charité University Medicine and Max Delbrueck Center for Molecular Medicine, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Capsules with 160 mg Teavigo (at least 94% EGCG) in people with Multiple Sclerosis, Relapsing-Remitting, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01417312, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2021.