Rheumatoid ArthritisNutriFastNCT03856190
Effectiveness of Therapeutic Fasting and Specific Diet in Patients With Rheumatoid Arthritis
A study testing Fasting and plant-based nutrition and Standard Nutrition Counselling in people with Rheumatoid Arthritis, run by Charite University, Berlin, Germany at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Fasting and plant-based nutrition and Standard Nutrition Counselling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 2 sitesGermany
- Study dates
- 18 Mar 2019to 7 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Gout or septic arthritis
- Psychiatric disease that interferes with the understanding and implementation of the intervention
- Pregnancy or breast feeding
- In the case of pronounced anemia (Hb <10 mg / dl) no inclusion in the examination or no additional blood sampling is carried out
- 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
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Charité Hochschulambulanz für Naturheilkunde, Immanuel Krankenhaus Berlin
Berlin, 14163
Charité University, Berlin, Department of Rheumatology and Clinical Immunology
Berlin
About this study
Official title: Effectiveness of Therapeutic Fasting and Specific Diet in Patients With Rheumatoid Arthritis: a Randomized Controlled Clinical Trial
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.
Read the 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
- Being tested
- Fasting and plant-based nutrition, Standard Nutrition Counselling
- Keywords
- Fasting, Vegan, Plant based, Randomized Trial
- Medical subject headings
- Arthritis, Rheumatoid, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Fasting and "best practice" nutrition | Active comparator | Initial fasting followed by 11 weeks plant-based diet Receives: Other: Fasting and plant-based nutrition |
| Standard Nutrition Counselling | Active comparator | 12 weeks standard antiinflammatory diet Receives: Other: Standard Nutrition Counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Date of inclusion (baseline), day 7, after 6 and 12 weeks
Secondary outcomes (40)
Disease Activity Score 28 (DAS-28-CRP)
Change from Baseline in the DAS-28-CRP, range from 2.0 to 10.0 while higher values meaning a higher disease activity and below of 2.6 meaning remission
Measured: Date of inclusion (baseline), day 7, after 6 and 12 weeks
American College of Rheumatology (ACR) response criteria
Change from Baseline in fulfilling the ACR response criteria indicating therapy response rate in percent (none, ACR20, ACR50 or ACR70)
Measured: Date of inclusion (baseline), day 7, after 6 and 12 weeks
Simplified Disease Activity Index Score (SDAI)
Change from Baseline in the SDAI, range from 0 to 86 with assumed range from 0.1 to 10mg/dL for CRP. Higher values mean a higher disease activity and below of 34 meaning remission.
Measured: Date of inclusion (baseline), day 7, after 6 and 12 weeks
Bio-electrical impedance analysis (BIA)
Estimation of the body composition via bio-electrical impedance analysis (body fat and visceral fat in %)
Measured: Date of inclusion (baseline), after 6 and 12 weeks
Bio-electrical impedance analysis (BIA)
Estimation of the body composition via bio-electrical impedance analysis (muscle mass in kg)
Measured: Date of inclusion (baseline), after 6 and 12 weeks
Abdominal circumference
Measured: Date of inclusion (baseline), after 6 and 12 weeks
Resting blood pressure
Measured: Date of inclusion (baseline), after 6 and 12 weeks
Pulse rate
Measured: Date of inclusion (baseline), after 6 and 12 weeks
Differential blood count
Measured: Date of inclusion (baseline), day 7, after 6 and 12 weeks
Hepatic transaminases (GPT, GOT) and Gamma glutamyl transpeptidase (y-GT)
- GPT in units per liter (U/L)
- GOT (U/L)
- y-GT (U/L)
Measured: Date of inclusion (baseline), day 7, after 6 and 12 weeks
Total protein in grams per liter (g/L)
Measured: Date of inclusion (baseline), day 7, after 6 and 12 weeks
Creatinine in µmol per liter (µmol/L)
Measured: Date of inclusion (baseline), day 7, after 6 and 12 weeks
Creatine kinase (U/L)
Measured: Date of inclusion (baseline), day 7, after 6 and 12 weeks
Estimated glomerular filtration rate (eGFR) in milliliter per minute (mL/min)
Measured: Date of inclusion (baseline), day 7, after 6 and 12 weeks
Electrolytes
- calcium in millimol per liter (mmol/L)
- potassium (mmol/L)
- sodium (mmol/L)
Measured: Date of inclusion (baseline), day 7, after 6 and 12 weeks
Erythrocyte sedimentation rate (ESR) in millimeters per hour (mm/h)
Measured: Date of inclusion (baseline), day 7, after 6 and 12 weeks
CRP in milligram per liter (mg/L)
Measured: Date of inclusion (baseline), day 7, after 6 and 12 weeks
International normalized ratio (INR)
Measured: Date of inclusion (baseline), day 7, after 6 and 12 weeks
Partial thromboplastin time (PTT) in seconds (s)
Measured: Date of inclusion (baseline), day 7, after 6 and 12 weeks
Lactate dehydrogenase (LDH) (U/L)
Measured: Date of inclusion (baseline), day 7, after 6 and 12 weeks
Blood lipids and fasting glucose
- triglycerides (mmol/L)
- total cholesterol (mmol/L)
- LDL (mmol/L)
- HDL (mmol/L)
- fasting glucose (mmol/L)
Measured: Date of inclusion (baseline), day 7, after 6 and 12 weeks
Uric acid (µmol/L)
Measured: Date of inclusion (baseline), day 7, after 6 and 12 weeks
Rheumatoid factor (IgM)
Measured: Date of inclusion (baseline)
Anti-cyclic citrullinated peptide (anti-CCP)
Measured: Date of inclusion (baseline), day 7, after 6 and 12 weeks
Phenotyping of immune cells
Determination of cytometric parameters that indicate changes in cell activation or quantitative changes in the absolute and/or relative size of subpopulations (e.g. classical/intermediate/non-classical monocytes, naïve and memory T-cells, B-cell differentiation to plasmablasts/-cells) Gene expression analysis of immune cells with Affymetrix whole genome microarrays and RNAseq to search for transcriptional patterns and markers that help to identify relevant immune cell (sub-)populations, which are not yet included in the cytometric phenotyping screen
Measured: Date of inclusion (baseline), day 7, after 6 and 12 weeks
Metabolic plasma metabolites
Metabolic plasma metabolites of carbon metabolism with a blood spot extract using metabolomics (GC / MS)
Measured: Date of inclusion (baseline), day 7, after 6 and 12 weeks
Urine analysis (10 ml midstream urine)
Measured: Date of inclusion (baseline), day 7, after 6 and 12 weeks
Gut microbiome
Molecular typing of the extremely individual intestinal microbiota composition by sequencing of stool material (16S-, 18S-, ITS-amplicon sequencing, metagenomics, metatranscriptomics) and performing proteomics and metabolomics to characterize fasting and diet induced changes of the so far insufficiently characterized gut microbiota related molecular components in a subgroup of patients
Measured: Date of inclusion (baseline), day 7, week 6 and week 12
Sociodemographic Measurements
age, education level, household income, employment status, marital status, language spoken, complete family history of rheumatoid arthritis in first- and second-degree relatives, current and previous illness and co-morbidities, and current medications
Measured: Date of inclusion (baseline)
Medication intake
Systematized documentation of medication, main and secondary diagnoses using CRF
Measured: Date of inclusion (baseline), after 6 and 12 weeks
Analgetics intake
Systematized documentation of analgetic medication on a daily basis using a diary
Measured: Up to 12 weeks
Documentation of Behavioral Factors
Documentation of digestion, menstruation, compliance on diet and extraordinary events on a daily basis using a diary
Measured: Up to 12 weeks
Quantification of Behavioral Factors
Documentation of occupational stress, domestic stress, interpersonal conflicts on a daily basis using a diary via visual analog scale (VAS), range from 0 to 10 while higher values meaning a higher grade of stress
Measured: Up to 12 weeks
Quantification of Behavioral Factors
Nicotine, Alcohol, Physical Inactivity, Coffee and Media Consumption via Likert Scales, range from 0 to 5 while higher values meaning a higher grade of agreement
Measured: Date of inclusion (baseline), after 6 and 12 weeks
Food selection
Nutritional history via dietary record (each for 3 days)
Measured: Date of inclusion (baseline), after 4 and 9 weeks
Dietary Behaviour
Modified FFQ recording dietary behaviour such as mealtimes, frequency of food intake, food preferences, fasting experiences
Measured: Date of inclusion (baseline), after 6 and 12 weeks
The Hannover Functional Ability Questionnaire (Funktionsfragebogen Hannover, FFbH-R)
Change from Baseline in the FFbH-R, range from 0 to 100 % while higher values meaning a higher grade of functional capacity
Measured: Date of inclusion (baseline), after 6 and 12 weeks, after 6 months
Mood questionnaire (Profile of Mood States, POMS)
Change from Baseline in Emotional Distress will be measured using the German Version of the Profile of Mood States (POMS) short version (35 items, 7-point Likert scale; 0=not at all, 6=extremely). It has 65 items and 6 domains: depression [range 0 - 98], vigour-activity [range 0 - 49], fatigue [range 0 - 49], and anger-hostility [range 0 - 49]. The total mood disturbance score is derived by subtracting the vigour-activity score from the the sum of scores from the other subscales. Lower scores indicate more stable mood profiles.
Measured: Date of inclusion (baseline), after 6 and 12 weeks, after 6 months
Stress questionnaire (Cohen Perceived Stress Scale, CPSS)
Change from Baseline in the CPSS, range from 0 to 4 in each item. Scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 \& 4 = 0) to the positively stated items and then summing across all scale items while higher values meaning a higher grade of perceived stress.
Measured: Date of inclusion (baseline), after 6 and 12 weeks, after 6 months
Quality of Life questionnaire (WHO-5)
Change from Baseline in the WHO-5, range from 0 to 100 % while higher values meaning a higher grade of well-being
Measured: Date of inclusion (baseline), after 6 and 12 weeks, after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start18 Mar 2019
- Primary completion8 Apr 2021
- Study completion7 Jul 2021
Why it stopped: Covid pandemic, research halt, expiring funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Braunschweig Integrated Centre of Systems Biology (BRICS), Germany, University of Luxembourg
- Responsible party
- Principal investigator, Andreas Michalsen, Charite University, Berlin, Germany
- Investigators
- Andreas Michalsen, Prof. Dr., Principal investigator, Charité Hochschulambulanz für Naturheilkunde, Immanuel Krankenhaus Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03856190
- Sponsor's protocol ID
- NutriFast
- Acronym
- NutriFast
- Status last verified
- Jul 2021
- First submitted
- 24 Jan 2019
- Last updated
- 7 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 36407522Hartmann 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.
PubMed 34380725
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Therapeutic Fasting and Specific Diet in Patients With Rheumatoid Arthritis: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03856190
- Acronym / sponsor ID
- NutriFast / NutriFast
- Conditions
- Rheumatoid Arthritis
- Keywords
- Fasting, Vegan, Plant based, Randomized Trial
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Covid pandemic, research halt, expiring funding
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Braunschweig Integrated Centre of Systems Biology (BRICS), Germany, University of Luxembourg
- Study start
- 18 Mar 2019 (actual)
- Primary completion
- 8 Apr 2021 (actual)
- Study completion
- 7 Jul 2021 (actual)
- First posted
- 27 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fasting and "best practice" nutrition | Active comparator | Other: Fasting and plant-based nutritionInitial fasting followed by 11 weeks plant-based diet |
| Standard Nutrition Counselling | Active comparator | Other: Standard Nutrition Counselling12 weeks standard antiinflammatory diet |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (8 listed)
- Gout or septic arthritis
- Psychiatric disease that interferes with the understanding and implementation of the intervention
- Pregnancy or breast feeding
- In the case of pronounced anemia (Hb <10 mg / dl) no inclusion in the examination or no additional blood sampling is carried out
- Underweight (BMI <18,5) or weight loss of >3kg/5kg in the last/last 3 month(s)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fasting and plant-based nutritionThe 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 | Fasting and "best practice" nutrition |
| Standard Nutrition CounsellingThe 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. | Other | Standard Nutrition Counselling |
Primary outcome
Health Assessement Questionnaire (HAQ)
Time frame: Date of inclusion (baseline), day 7, after 6 and 12 weeks
Change from Baseline in the HAQ after 12 weeks, range from 0 to 3 while higher values meaning a higher grade of disability
40 secondary outcomes
Disease Activity Score 28 (DAS-28-CRP)
Time frame: Date of inclusion (baseline), day 7, after 6 and 12 weeks
American College of Rheumatology (ACR) response criteria
Time frame: Date of inclusion (baseline), day 7, after 6 and 12 weeks
Simplified Disease Activity Index Score (SDAI)
Time frame: Date of inclusion (baseline), day 7, after 6 and 12 weeks
Bio-electrical impedance analysis (BIA)
Time frame: Date of inclusion (baseline), after 6 and 12 weeks
Bio-electrical impedance analysis (BIA)
Time frame: Date of inclusion (baseline), after 6 and 12 weeks
Abdominal circumference
Time frame: Date of inclusion (baseline), after 6 and 12 weeks
Resting blood pressure
Time frame: Date of inclusion (baseline), after 6 and 12 weeks
Pulse rate
Time frame: Date of inclusion (baseline), after 6 and 12 weeks
Differential blood count
Time frame: Date of inclusion (baseline), day 7, after 6 and 12 weeks
Hepatic transaminases (GPT, GOT) and Gamma glutamyl transpeptidase (y-GT)
Time frame: Date of inclusion (baseline), day 7, after 6 and 12 weeks
Total protein in grams per liter (g/L)
Time frame: Date of inclusion (baseline), day 7, after 6 and 12 weeks
Creatinine in µmol per liter (µmol/L)
Time frame: Date of inclusion (baseline), day 7, after 6 and 12 weeks
Creatine kinase (U/L)
Time frame: Date of inclusion (baseline), day 7, after 6 and 12 weeks
Estimated glomerular filtration rate (eGFR) in milliliter per minute (mL/min)
Time frame: Date of inclusion (baseline), day 7, after 6 and 12 weeks
Electrolytes
Time frame: Date of inclusion (baseline), day 7, after 6 and 12 weeks
Erythrocyte sedimentation rate (ESR) in millimeters per hour (mm/h)
Time frame: Date of inclusion (baseline), day 7, after 6 and 12 weeks
CRP in milligram per liter (mg/L)
Time frame: Date of inclusion (baseline), day 7, after 6 and 12 weeks
International normalized ratio (INR)
Time frame: Date of inclusion (baseline), day 7, after 6 and 12 weeks
Partial thromboplastin time (PTT) in seconds (s)
Time frame: Date of inclusion (baseline), day 7, after 6 and 12 weeks
Lactate dehydrogenase (LDH) (U/L)
Time frame: Date of inclusion (baseline), day 7, after 6 and 12 weeks
Blood lipids and fasting glucose
Time frame: Date of inclusion (baseline), day 7, after 6 and 12 weeks
Uric acid (µmol/L)
Time frame: Date of inclusion (baseline), day 7, after 6 and 12 weeks
Rheumatoid factor (IgM)
Time frame: Date of inclusion (baseline)
Anti-cyclic citrullinated peptide (anti-CCP)
Time frame: Date of inclusion (baseline), day 7, after 6 and 12 weeks
Phenotyping of immune cells
Time frame: Date of inclusion (baseline), day 7, after 6 and 12 weeks
Metabolic plasma metabolites
Time frame: Date of inclusion (baseline), day 7, after 6 and 12 weeks
Urine analysis (10 ml midstream urine)
Time frame: Date of inclusion (baseline), day 7, after 6 and 12 weeks
Gut microbiome
Time frame: Date of inclusion (baseline), day 7, week 6 and week 12
Sociodemographic Measurements
Time frame: Date of inclusion (baseline)
Medication intake
Time frame: Date of inclusion (baseline), after 6 and 12 weeks
Analgetics intake
Time frame: Up to 12 weeks
Documentation of Behavioral Factors
Time frame: Up to 12 weeks
Quantification of Behavioral Factors
Time frame: Up to 12 weeks
Quantification of Behavioral Factors
Time frame: Date of inclusion (baseline), after 6 and 12 weeks
Food selection
Time frame: Date of inclusion (baseline), after 4 and 9 weeks
Dietary Behaviour
Time frame: Date of inclusion (baseline), after 6 and 12 weeks
The Hannover Functional Ability Questionnaire (Funktionsfragebogen Hannover, FFbH-R)
Time frame: Date of inclusion (baseline), after 6 and 12 weeks, after 6 months
Mood questionnaire (Profile of Mood States, POMS)
Time frame: Date of inclusion (baseline), after 6 and 12 weeks, after 6 months
Stress questionnaire (Cohen Perceived Stress Scale, CPSS)
Time frame: Date of inclusion (baseline), after 6 and 12 weeks, after 6 months
Quality of Life questionnaire (WHO-5)
Time frame: Date of inclusion (baseline), after 6 and 12 weeks, after 6 months
Results and safety
The study was stopped early (reason given: Covid pandemic, research halt, expiring funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2022.
- Derived from this study: PubMed 36407522Hartmann 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.
- Derived from this study: PubMed 34380725Hartmann 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.
- Individual participant dataSharing planned: Yes. 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.
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A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Michalsen, Prof. Dr. principal investigator
Charité Hochschulambulanz für Naturheilkunde, Immanuel Krankenhaus Berlin
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fasting and plant-based nutrition and Standard Nutrition Counselling in people with Rheumatoid Arthritis, run by Charite University, Berlin, Germany at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Covid pandemic, research halt, expiring funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Assessement Questionnaire (HAQ) (time frame: Date of inclusion (baseline), day 7, after 6 and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03856190, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2022.