Metabolic Effects of a Green Tea Extract in Multiple Sclerosis Patients

Charité University Medicine Berlin

Status: Completed

Conditions: Multiple Sclerosis, Relapsing-Remitting

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Capsules with 160 mg Teavigo (at least 94% EGCG)

Study type: Interventional

Funder types: Other

Identifiers

NCT01417312

MS_GTE

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

---

20 participants in 2 patient groups, including a placebo group

Green tea extract

Active Comparator group

Treatment:

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

Placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo