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Nutritional Approaches in Multiple Sclerosis

NCT03508414 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2021-07-29

No results posted yet for this study

Summary

The aim of this project is to characterize the influence of a ketogenic diet and intermittent therapeutical fasting on the course of the disease, as measured by T2-hyperintense cerebral lesions with magnetic resonance tomography (MRT) in patients with multiple sclerosis (RRMS). The investigators expect in both intervention groups fewer cerebral T2 lesions occurring after 18 months in comparison to the control group and as detectable by MRT. According to current recommendations of the German Society of Nutrition (DGE), the control group receives a vegetarian-focused, anti-inflammatory diet.

Conditions

Interventions

BEHAVIORAL

ketogenic diet

Patients receive a ketogenic diet, which is carbohydrate-reduced with a high amount of fat.

BEHAVIORAL

Intermittent therapeutical fasting

Patients fast for 1 week every six months. Additionally, the patients do an intermittent fasting, that is to say they do not eat for at least 14 hours a day.

BEHAVIORAL

Active comparator

The control group is receiving a vegetarian-focused diet according to the current recommendations of the German Society for Nutrition (DGE) for MS patients.

Sponsors & Collaborators

  • Charite University, Berlin, Germany

    lead OTHER

Principal Investigators

  • Friedemann Paul, Dr. med. · Charite University, Berlin, Germany

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-11
Primary Completion
2021-12-01
Completion
2021-12-01

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03508414 on ClinicalTrials.gov