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Effectiveness of Therapeutic Fasting and Specific Diet in Patients With Rheumatoid Arthritis

NCT03856190 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2022-02-07

No results posted yet for this study

Summary

The aim of this trial is an evaluation of the effectiveness of fasting and a subsequent diagnosis-specific diet change in patients with rheumatoid arthritis in respect to improving rheumatic symptoms and further to investigate possible mechanisms of this improvement.

Conditions

Interventions

OTHER

Fasting and plant-based nutrition

The experimental intervention is divided into an initial part with periodic fasting for 7-10 days on an outpatient basis, which is followed by a build-up phase. This group part then receives a diet change with a specific normocaloric nutrition including the concept of time restricted eating (TRE, 16/8h) and according to the following criteria: 1) plant-based, 2) rich in prebiotics, 3) enriched with kitchen spices and kitchen herbs known for their anti-mycotic and anti-inflammatory potential.

OTHER

Standard Nutrition Counselling

The control group receives a diet considered to be fundamentally beneficial to health in the sense of the recommendations of the German Association for Nutrition (DGE), which contain a reduced intake of arachidonic acid and, as a result, modulate an anti-inflammatory effect.

Sponsors & Collaborators

  • Braunschweig Integrated Centre of Systems Biology (BRICS), Germany

    collaborator UNKNOWN

  • University of Luxembourg

    collaborator OTHER

  • Charite University, Berlin, Germany

    lead OTHER

Principal Investigators

  • Andreas Michalsen, Prof. Dr. · Charité Hochschulambulanz für Naturheilkunde, Immanuel Krankenhaus Berlin

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-03-18
Primary Completion
2021-04-08
Completion
2021-07-07

Countries

  • Germany

Study Locations

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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 NCT03856190 on ClinicalTrials.gov