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

NCT ID: NCT03856190

Last Updated: 2022-02-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-18
• Study Completion Date: 2021-07-07

Brief 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.

Detailed Description

Rheumatoid arthritis is an inflammatory-destructive joint disease for which up to date etiopathogenetical causes are lacking. In recent years, numerous new therapeutic concepts have been developed in the form of targeted antibody therapies that can block various inflammatory mechanisms. Although better treatment successes in comparison with conventional therapies were achieved, patients respond to the new therapies in very different ways. As a result the optimal drug needs to be identified for each patient through individual treatment trials. So far, no healings have been achieved and the progression of the disease can be stopped only by permanent suppression of the inflammatory response. In addition to different immunological mechanisms and genetic predispositions, interactions with the microbiome of the intestine are increasingly being discussed in recent years. A dysbiotic intestinal flora, characterized by the loss of beneficial bacteria and a concomitant increase in potentially pathogenic microbes, is associated with chronic inflammatory syndromes.

Modified fasting (up to 500 kcal energy intake per day) for 7-10 days leads to an improvement of the symptoms in many patients with rheumatoid arthritis and is regularly used by the applicants for the treatment of rheumatoid arthritis. Several clinical studies have shown that therapeutic fasting produces anti-inflammatory effects. However, so far no standardized method for long-term stabilization of corresponding effects after resumption of nutrition has been established.

Recent transcriptome analyzes have not only revealed numerous new potential markers, but also increasingly allow conclusions to be drawn from these extensive datasets that suggest immunological relationships between specific genes. In preliminary studies within the framework of a project of the same study group, it was possible to identify inflammatory profiles of individual foods and to identify molecular markers of disease activity in rheumatoid arthritis whose diagnostic value has been tested and interpreted under the influence of fasting. These markers will now be clinically evaluated in this study in collaboration with both centers.

The hypothesis is that a combination of fasting and subsequent diagnosis-specific diet change will improve the rheumatic symptoms. In this context, it will also be analyzed, which meaning of the changes 1) of the metabolism and 2) of the microbiome, mediated by fasting and nutrition, belongs. This will be demonstrated by using already identified markers for genotypic traits, gene expression traits, characteristics of protein expression, protein activities, and antigen-specific immunological response patterns.

The present research project aims to combine the different aspects of a possible anti-rheumatic nutrition and to evaluate the nutritherapeutic concept in an RCT. We suggest that a part of the anti-inflammatory effects of fasting and best practice diets may be due to a change in the composition of the intestinal flora mediated. Thus this study contributes to the extended therapy of rheumatoid arthritis.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Fasting and "best practice" nutrition

Initial fasting followed by 11 weeks plant-based diet

Group Type: ACTIVE_COMPARATOR

Fasting and plant-based nutrition

Intervention Type: OTHER

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.

Standard Nutrition Counselling

12 weeks standard antiinflammatory diet

Group Type: ACTIVE_COMPARATOR

Standard Nutrition Counselling

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Rheumatoid arthritis

2. free of any serious medical condition that precludes safe participation in an exercise program, such as coronary artery disease, severe hypertension, peripheral vascular disease, stroke, congestive heart failure, chronic obstructive pulmonary disease, insulin-dependent diabetes, psychiatric disease, renal disease, liver disease, active cancer other than skin cancer, and anemia

3. Ability to understand the intervention concept and written consent to participate;

4. Willingness to accept randomization and undergo the testing and intervention procedures and deliver stool, blood and urine samples for testing

5. Age 18-70 years (inclusive)

6. drug therapy was not started in the last 8 weeks before screening

Exclusion Criteria

1. Gout or septic arthritis

2. Psychiatric disease that interferes with the understanding and implementation of the intervention

3. Pregnancy or breast feeding

4. In the case of pronounced anemia (Hb <10 mg / dl) no inclusion in the examination or no additional blood sampling is carried out

5. Underweight (BMI <18,5) or weight loss of >3kg/5kg in the last/last 3 month(s)

6. Eating disorder (such as bulimia, anorexia nervosa) in the last 5 years

7. Current vegan nutrition

8. Non-existence of email address or internet access

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Braunschweig Integrated Centre of Systems Biology (BRICS), Germany

UNKNOWN

Sponsor Role: collaborator

University of Luxembourg

OTHER

Sponsor Role: collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Andreas Michalsen

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andreas Michalsen, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Charité Hochschulambulanz für Naturheilkunde, Immanuel Krankenhaus Berlin

Locations

Charité Hochschulambulanz für Naturheilkunde, Immanuel Krankenhaus Berlin

Berlin, , Germany

Charité University, Berlin, Department of Rheumatology and Clinical Immunology

Berlin, , Germany

Countries

Germany

References

Hartmann AM, Dell'Oro M, Spoo M, Fischer JM, Steckhan N, Jeitler M, Haupl T, Kandil FI, Michalsen A, Koppold-Liebscher DA, Kessler CS. To eat or not to eat-an exploratory randomized controlled trial on fasting and plant-based diet in rheumatoid arthritis (NutriFast-Study). Front Nutr. 2022 Nov 2;9:1030380. doi: 10.3389/fnut.2022.1030380. eCollection 2022.

Reference Type: DERIVED

PMID: 36407522 (View on PubMed)

Hartmann AM, Dell'Oro M, Kessler CS, Schumann D, Steckhan N, Jeitler M, Fischer JM, Spoo M, Kriegel MA, Schneider JG, Haupl T, Kandil FI, Michalsen A, Koppold-Liebscher DA. Efficacy of therapeutic fasting and plant-based diet in patients with rheumatoid arthritis (NutriFast): study protocol for a randomised controlled clinical trial. BMJ Open. 2021 Aug 11;11(8):e047758. doi: 10.1136/bmjopen-2020-047758.

Reference Type: DERIVED

PMID: 34380725 (View on PubMed)

Other Identifiers

NutriFast

Identifier Type: -

Identifier Source: org_study_id