NCT03856190

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 27, 2019

Completed
19 days until next milestone

Study Start

First participant enrolled

March 18, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 8, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2021

Completed
Last Updated

February 7, 2022

Status Verified

July 1, 2021

Enrollment Period

2.1 years

First QC Date

January 24, 2019

Last Update Submit

January 24, 2022

Conditions

Rheumatoid Arthritis

Keywords

FastingVeganPlant basedRandomized Trial

Outcome Measures

Primary Outcomes (1)

  • Health Assessement Questionnaire (HAQ)

    Change from Baseline in the HAQ after 12 weeks, range from 0 to 3 while higher values meaning a higher grade of disability

    Date of inclusion (baseline), day 7, after 6 and 12 weeks

Secondary Outcomes (40)

  • Disease Activity Score 28 (DAS-28-CRP)

    Date of inclusion (baseline), day 7, after 6 and 12 weeks

  • American College of Rheumatology (ACR) response criteria

    Date of inclusion (baseline), day 7, after 6 and 12 weeks

  • Simplified Disease Activity Index Score (SDAI)

    Date of inclusion (baseline), day 7, after 6 and 12 weeks

  • Bio-electrical impedance analysis (BIA)

    Date of inclusion (baseline), after 6 and 12 weeks

  • Bio-electrical impedance analysis (BIA)

    Date of inclusion (baseline), after 6 and 12 weeks

  • +35 more secondary outcomes

Other Outcomes (1)

  • Final questionnaire to record tolerability of fasting and nutrition, adverse effects

    after 12 weeks

Study Arms (2)

Fasting and "best practice" nutrition

ACTIVE COMPARATOR

Initial fasting followed by 11 weeks plant-based diet

Other: Fasting and plant-based nutrition

Standard Nutrition Counselling

ACTIVE COMPARATOR

12 weeks standard antiinflammatory diet

Other: Standard Nutrition Counselling

Interventions

Fasting and plant-based nutritionOTHER

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.

Fasting and "best practice" nutrition
Standard Nutrition CounsellingOTHER

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.

Standard Nutrition Counselling

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Rheumatoid arthritis
  • 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
  • Ability to understand the intervention concept and written consent to participate;
  • Willingness to accept randomization and undergo the testing and intervention procedures and deliver stool, blood and urine samples for testing
  • Age 18-70 years (inclusive)
  • drug therapy was not started in the last 8 weeks before screening

You may not qualify if:

  • Gout or septic arthritis
  • Psychiatric disease that interferes with the understanding and implementation of the intervention
  • Pregnancy or breast feeding
  • Underweight (BMI \<18,5) or weight loss of \>3kg/5kg in the last/last 3 month(s)
  • Eating disorder (such as bulimia, anorexia nervosa) in the last 5 years
  • Current vegan nutrition
  • Non-existence of email address or internet access

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Charité Hochschulambulanz für Naturheilkunde, Immanuel Krankenhaus Berlin

Berlin, 14163, Germany

Location

Charité University, Berlin, Department of Rheumatology and Clinical Immunology

Berlin, Germany

Location

Related Publications (2)

  • 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.

    PMID: 36407522DERIVED

  • 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.

    PMID: 34380725DERIVED

MeSH Terms

Conditions

Arthritis, RheumatoidFasting

Interventions

Diet, Plant-Based

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesFeeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Andreas Michalsen, Prof. Dr.

    Charité Hochschulambulanz für Naturheilkunde, Immanuel Krankenhaus Berlin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 24, 2019

First Posted

February 27, 2019

Study Start

March 18, 2019

Primary Completion

April 8, 2021

Study Completion

July 7, 2021

Last Updated

February 7, 2022

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will share

The study protocol is to be published open access. On publishing the outcomes, the anonymized individual participant data that underlie the reported results, as well as the statistical code, will be made available to scientific investigators who issue a methodologically sound proposal.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
10 years after publication of primary results
Access Criteria
* scientific objective (non-commercial) * sound methodology

Locations

DE(2)