Arthritis, RheumatoidNCT04739852
An Exploratory Clinical Study on Autophagy During Fasting
A study testing Fasting in people with Arthritis, Rheumatoid and Syndrome, Metabolic, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Autophagy is considered one of the key molecular mechanisms for the broad preventive and therapeutic effects of periodic fasting. While it is generally known that fasting induces autophagy, there are no human studies that focus on the size and temporal kinetics of autophagy and its association with fasting specific… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Arthritis, Rheumatoid, Syndrome, Metabolic, Healthy
- What is being tested?
- Fasting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 1 Feb 2021to 1 Jul 2025
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- One of the following diagnoses: rheumatoid arthritis, metabolic syndrome OR healthy volunteer
- Beginning (first 24h) inpatient treatment or hospital stay at Immanuel Hospital Berlin, Department of Naturopathy OR healthy volunteer
- Present written declaration of consent
Who cannot join
- Insufficient linguistic communication
- Dementia or other cognitive disorder
- Pregnancy or lactation
- Simultaneous participation in another clinical trial
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Hochschulambulanz für Naturheilkunde der Charité-Universitätsmedizin Berlin am Immanuel-Krankenhaus
Berlin, 14109
Miriam Rösner, Study nurse, 00493080505682, miriam.roesner@immanuel.de
Andreas Michalsen, Prof. Dr.
About this study
Official title: The Kinetics of Autophagy During Periodic Fasting in Healthy People and Patients With Rheumatoid Arthritis or Metabolic Syndrome - an Exploratory Clinical Study
Autophagy is considered one of the key molecular mechanisms for the broad preventive and therapeutic effects of periodic fasting. While it is generally known that fasting induces autophagy, there are no human studies that focus on the size and temporal kinetics of autophagy and its association with fasting specific signaling pathways. The kinetics of autophagy in patients with chronic diseases will now be compared with the kinetics of autophagy in healthy subjects, who both fast according to the same scheme; and further changes in metabolic and inflammatory parameters will be investigated.
Read the detailed description
Therapeutic fasting has been used for many decades in naturopathy and integrative medicine clinically successfully in the treatment of chronic diseases and pain syndromes. In particular, fasting therapy is used for chronic rheumatic, inflammatory, and metabolic diseases with increasing patient demand in specialized clinical facilities (fasting clinics).
Within the various historically developed forms of fasting, the fasting program according to the Buchinger Wilhelmi method has established itself worldwide as the most frequently applied method. This involves a subtotal caloric restriction with a daily caloric intake (200-400kcal/day) in the form of liquid components over a defined period of at least 10 days, accompanied by supporting measures of a health-promoting lifestyle program with elements such as exercise therapy, manual procedures, stress reduction and hydro-balneotherapy.
In early randomized studies and a systematic review, the effectiveness of inpatient fasting therapy for patients with rheumatoid arthritis was proven with 1a evidence. For the other indications, there is mainly empirical evidence or data from observation or prospective uncontrolled studies. In recent years, extensive basic science research activity has developed in the area of caloric restriction and intermittent fasting. In this context, a large number of favorable animal experimental findings have been demonstrated by defined fasting periods, including reductions in insulin, IGF-1, increases in adiponectins, insulin sensitivity, neurotrophic factors, and, over longer observation periods, a decrease in the incidence of cardiovascular, inflammatory, and metabolic, and more recently oncological diseases in a wide variety of animal species.
Numerous experimental studies have demonstrated that fasting or total or subtotal caloric restriction is a potent inducer of cellular autophagy. For autophagy, numerous beneficial effects on chronic diseases or disease defense functions have now been experimentally documented and also hypothesized for humans, including neurodegenerative and metabolic diseases, but also acute infections and inflammatory diseases. Unclear to date is the kinetics of the autophagy enhancing effect of fasting. In theoretical transfer from animal experimental data, an increase is postulated between 12 and 36h of fasting and possibly a decrease after several days.
Against this background, autophagy will now be investigated for the first time in blood samples from fasting healthy and diseased individuals in an exploratory clinical study.
- Conditions
- Arthritis, Rheumatoid, Syndrome, Metabolic, Healthy
- Being tested
- Fasting
- Keywords
- Fasting, Autophagy
- Medical subject headings
- Arthritis, Rheumatoid, Metabolic Syndrome, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FastingOther
Patients undergo a 5-10 day fasting period with a dietary energy supply 350-400kcal per day with fruit and vegetable juices or, if not feasible, an established fasting-mimicking diet of 600-800 kcal according to Longo et al.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Participants | Active comparator | Healthy participants Receives: Other: Fasting |
| Metabolic Syndrome | Active comparator | Participants with diagnosed metabolic syndrome Receives: Other: Fasting |
| Rheumatoid Arthritis | Active comparator | Participants with diagnosed rheumatoid arthritis Receives: Other: Fasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exploratory Proteomics of Autophagy Processes I
- Change in protein levels of autophagy biomarkers (LC3II \& p62) of isolated PBMCs (peripheral blood mononuclear cells) by Western Blotting, change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
Measured: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
Exploratory Proteomics of Autophagy Processes II
- Change in protein levels and protein phosphorylation by untargeted mass spectrometry-based proteomics and phosphoproteomics of isolated PBMCs (peripheral blood mononuclear cells), change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
Measured: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
Secondary outcomes (39)
Muscle mass
Estimation of the body composition via bio-electrical impedance analysis (muscle mass in kg)
Measured: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
Body fat
Estimation of the body composition via bio-electrical impedance analysis (body fat and visceral fat in %)
Measured: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
Resting blood pressure
Measured: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
Cutaneous carotenoid level (CCL)
Cutaneous carotenoid level (CCL), correlating with the overall antioxidant status, measured with a noninvasive skin carotenoid sensor (Biozoom®)
Measured: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
Heart rate
Measured: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
Waist to Hip Ratio
Measured: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
Body Mass Index (kg/m2)
Measured: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
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: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
Health Assessement Questionnaire (HAQ)
Change from Baseline in the HAQ, range from 0 to 3 while higher values meaning a higher grade of disability
Measured: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
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: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
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, higher values meaning a higher grade of perceived stress.
Measured: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
Mindful Attention Awareness Scale (MAAS)
Assessing full scale, range from 15 to 90, higher score values meaning a better outcome.
Measured: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
Numerical Analog Scales
Assessing stress, back pain, headache, shoulder/neck tension, sleep quality and duration, exhaustion, nervousness, digestive complaints, mood on 0-10 points each.
Measured: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
Quality of Life questionnaire (WHO-5)
Change from Baseline in the WHO-5, range from 0 to 100 %, higher values meaning a higher grade of well-being
Measured: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
Hospital Anxiety and Depression Scale (HADS)
Assessing full scale, range 0-42, lower score meaning a better outcome
Measured: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
General Self-efficacy Short Scale (ASKU)
Assessing full scale, range 3-15, higher score meaning a better outcome
Measured: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
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 (ASTS) short version (19 items, 7-point Likert scale; 0=not at all, 6=extremely). Lower scores indicate more stable mood profiles.
Measured: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
Sociodemographic Measurements
Age, gender, education level, household income, employment status, marital status, language spoken, complete family history, current and previous illness and co-morbidities, and current medications
Measured: Day 1 (baseline)
Behavioral Factors
Physical inactivity, coffee, health promoting activities via Likert Scales, range from 0 to 5 while higher values meaning a higher grade of agreement
Measured: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
Behavioral Factors: alcohol consumption
Number of alcoholic beverages on average per week in the last month
Measured: Day 1 (baseline), after 2 and 6 weeks
Behavioral Factors: smoking
Number of cigarettes on average per week in the last month
Measured: Day 1 (baseline), after 2 and 6 weeks
Behavioral Factors: fasting experience
Type, definition, duration and date of previous fasting experiences
Measured: Day 1 (baseline)
Expectation questions
For fasting on a 5-point likert scale from 1 (nothing at all) to 5 (very strong)
Measured: Day 1 (baseline)
Creatinine in µmol per liter (µmol/L)
Measured: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
Estimated glomerular filtration rate (eGFR) in milliliter per minute (mL/min)
Measured: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
Electrolytes
potassium (mmol/L) sodium (mmol/L)
Measured: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
Blood lipids and fasting glucose
triglycerides (mmol/L) total cholesterol (mmol/L) LDL (mmol/L) HDL (mmol/L) fasting glucose (mmol/L)
Measured: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
Insulin (mU/L)
Measured: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
ß-Hydroxybutyrate
Evaluate change in ketone body production by POCT
Measured: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
CrP (mg/L)
Evaluate change in CrP levels in participants with RA
Measured: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
Erythrocyte sedimentation rate (ESR) in millimeters per hour (mm/h)
Evaluate change in ESR in participants with RA
Measured: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
Rheumatoid factor (RF, IgM) (U/mL)
Evaluate RF status in participants with RA
Measured: Day 1 (baseline)
Anti-cyclic citrullinated peptide (ACPA) (U/mL)
Evaluate change in ACPA levels in participants with RA
Measured: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
Metabolic processes
Targeted and quantitative analysis by mass spectrometry of change in metabolites of plasma, change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
Measured: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
Lipid profiling
Targeted and quantitative analysis by mass spectrometry of change in plasma lipids, change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
Measured: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
Transcription expression patterns
Change of the gene expression profile by RNA sequencing of isolated PBMCs (peripheral blood mononuclear cells), change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
Measured: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
Proteome/phosphoproteome/ubiquitinome patterns
Evaluate proteome expression patterns through blood based proteome, phosphoproteome, and ubiquitinome analysis assessed prior to intervention (pre) vs. after 5-day fasting, day 2 of refeeding and 7 days post intervention
Measured: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
Epigentic patterns
Evaluate epigentic methylation patterns through blood based epigenome analysis assessed prior to intervention (pre) vs. after 5-day fasting, day 2 of refeeding and 7 days post intervention
Measured: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
Exosomal protein patterns
Evaluate exosomal protein content through blood based metabolome analysis assessed prior to intervention (pre) vs. after 5-day fasting, day 2 of refeeding and 7 days post intervention
Measured: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start1 Feb 2021
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, RheumatoidStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 3 groups of different inclusion criteria (healthy, metabolic syndrome or rheumatoid arthritis) undergoing the same intervention
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Klinik und Poliklinik für Psychiatrie und Psychotherapie, Universitätsklinikum Bonn AöR
- Responsible party
- Principal investigator, Andreas Michalsen, Charite University, Berlin, Germany
- Investigators
- Andreas Michalsen, Prof. Dr., Principal investigator, Charite - Universitätsmedizin BerlinNils Gassen, Dr., Study director, Department of Psychiatry and Psychotherapy University Bonn, Clinical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04739852
- Sponsor's protocol ID
- Autophagy Fasting
- Status last verified
- Dec 2023
- First submitted
- 5 Jan 2021
- Last updated
- 2 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Kinetics of Autophagy During Periodic Fasting in Healthy People and Patients With Rheumatoid Arthritis or Metabolic Syndrome - an Exploratory Clinical Study
- ClinicalTrials.gov ID
- NCT04739852
- Acronym / sponsor ID
- Autophagy Fasting
- Conditions
- Arthritis, Rheumatoid, Syndrome, Metabolic, Healthy
- Keywords
- Fasting, Autophagy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Klinik und Poliklinik für Psychiatrie und Psychotherapie, Universitätsklinikum Bonn AöR
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 5 Feb 2021 (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.
Autophagy is considered one of the key molecular mechanisms for the broad preventive and therapeutic effects of periodic fasting. While it is generally known that fasting induces autophagy, there are no human studies that focus on the size and temporal kinetics of autophagy and its association with fasting specific signaling pathways. The kinetics of autophagy in patients with chronic diseases will now be compared with the kinetics of autophagy in healthy subjects, who both fast according to the same scheme; and further changes in metabolic and inflammatory parameters will be investigated.
Detailed description
Therapeutic fasting has been used for many decades in naturopathy and integrative medicine clinically successfully in the treatment of chronic diseases and pain syndromes. In particular, fasting therapy is used for chronic rheumatic, inflammatory, and metabolic diseases with increasing patient demand in specialized clinical facilities (fasting clinics).
Within the various historically developed forms of fasting, the fasting program according to the Buchinger Wilhelmi method has established itself worldwide as the most frequently applied method. This involves a subtotal caloric restriction with a daily caloric intake (200-400kcal/day) in the form of liquid components over a defined period of at least 10 days, accompanied by supporting measures of a health-promoting lifestyle program with elements such as exercise therapy, manual procedures, stress reduction and hydro-balneotherapy.
In early randomized studies and a systematic review, the effectiveness of inpatient fasting therapy for patients with rheumatoid arthritis was proven with 1a evidence. For the other indications, there is mainly empirical evidence or data from observation or prospective uncontrolled studies. In recent years, extensive basic science research activity has developed in the area of caloric restriction and intermittent fasting. In this context, a large number of favorable animal experimental findings have been demonstrated by defined fasting periods, including reductions in insulin, IGF-1, increases in adiponectins, insulin sensitivity, neurotrophic factors, and, over longer observation periods, a decrease in the incidence of cardiovascular, inflammatory, and metabolic, and more recently oncological diseases in a wide variety of animal species.
Numerous experimental studies have demonstrated that fasting or total or subtotal caloric restriction is a potent inducer of cellular autophagy. For autophagy, numerous beneficial effects on chronic diseases or disease defense functions have now been experimentally documented and also hypothesized for humans, including neurodegenerative and metabolic diseases, but also acute infections and inflammatory diseases. Unclear to date is the kinetics of the autophagy enhancing effect of fasting. In theoretical transfer from animal experimental data, an increase is postulated between 12 and 36h of fasting and possibly a decrease after several days.
Against this background, autophagy will now be investigated for the first time in blood samples from fasting healthy and diseased individuals in an exploratory clinical study.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 3 groups of different inclusion criteria (healthy, metabolic syndrome or rheumatoid arthritis) undergoing the same intervention
| Arm | Type | Receives |
|---|---|---|
| Healthy Participants | Active comparator | Other: FastingHealthy participants |
| Metabolic Syndrome | Active comparator | Other: FastingParticipants with diagnosed metabolic syndrome |
| Rheumatoid Arthritis | Active comparator | Other: FastingParticipants with diagnosed rheumatoid arthritis |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- One of the following diagnoses: rheumatoid arthritis, metabolic syndrome OR healthy volunteer
- Beginning (first 24h) inpatient treatment or hospital stay at Immanuel Hospital Berlin, Department of Naturopathy OR healthy volunteer
- Present written declaration of consent
Key exclusion criteria (4 listed)
- Insufficient linguistic communication
- Dementia or other cognitive disorder
- Pregnancy or lactation
- Simultaneous participation in another clinical trial
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 |
|---|---|---|
| FastingPatients undergo a 5-10 day fasting period with a dietary energy supply 350-400kcal per day with fruit and vegetable juices or, if not feasible, an established fasting-mimicking diet of 600-800 kcal according to Longo et al. | Other | Healthy Participants, Metabolic Syndrome, Rheumatoid Arthritis |
Primary outcome
Exploratory Proteomics of Autophagy Processes I
Time frame: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
- Change in protein levels of autophagy biomarkers (LC3II \& p62) of isolated PBMCs (peripheral blood mononuclear cells) by Western Blotting, change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
Exploratory Proteomics of Autophagy Processes II
Time frame: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
- Change in protein levels and protein phosphorylation by untargeted mass spectrometry-based proteomics and phosphoproteomics of isolated PBMCs (peripheral blood mononuclear cells), change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
39 secondary outcomes
Muscle mass
Time frame: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
Body fat
Time frame: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
Resting blood pressure
Time frame: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
Cutaneous carotenoid level (CCL)
Time frame: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
Heart rate
Time frame: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
Waist to Hip Ratio
Time frame: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
Body Mass Index (kg/m2)
Time frame: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
Disease Activity Score 28 (DAS-28-CRP)
Time frame: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
Health Assessement Questionnaire (HAQ)
Time frame: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
Simplified Disease Activity Index Score (SDAI)
Time frame: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
Stress questionnaire (Cohen Perceived Stress Scale, CPSS)
Time frame: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
Mindful Attention Awareness Scale (MAAS)
Time frame: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
Numerical Analog Scales
Time frame: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
Quality of Life questionnaire (WHO-5)
Time frame: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
Hospital Anxiety and Depression Scale (HADS)
Time frame: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
General Self-efficacy Short Scale (ASKU)
Time frame: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
Mood questionnaire (Profile of Mood States, POMS)
Time frame: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
Sociodemographic Measurements
Time frame: Day 1 (baseline)
Behavioral Factors
Time frame: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
Behavioral Factors: alcohol consumption
Time frame: Day 1 (baseline), after 2 and 6 weeks
Behavioral Factors: smoking
Time frame: Day 1 (baseline), after 2 and 6 weeks
Behavioral Factors: fasting experience
Time frame: Day 1 (baseline)
Expectation questions
Time frame: Day 1 (baseline)
Creatinine in µmol per liter (µmol/L)
Time frame: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
Estimated glomerular filtration rate (eGFR) in milliliter per minute (mL/min)
Time frame: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
Electrolytes
Time frame: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
Blood lipids and fasting glucose
Time frame: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
Insulin (mU/L)
Time frame: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
ß-Hydroxybutyrate
Time frame: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
CrP (mg/L)
Time frame: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
Erythrocyte sedimentation rate (ESR) in millimeters per hour (mm/h)
Time frame: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
Rheumatoid factor (RF, IgM) (U/mL)
Time frame: Day 1 (baseline)
Anti-cyclic citrullinated peptide (ACPA) (U/mL)
Time frame: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
Metabolic processes
Time frame: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
Lipid profiling
Time frame: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
Transcription expression patterns
Time frame: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
Proteome/phosphoproteome/ubiquitinome patterns
Time frame: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
Epigentic patterns
Time frame: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
Exosomal protein patterns
Time frame: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2024.
- Individual participant dataSharing planned: No
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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
Charite - Universitätsmedizin Berlin
Nils Gassen, Dr. study director
Department of Psychiatry and Psychotherapy University Bonn, Clinical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fasting in people with Arthritis, Rheumatoid and Syndrome, Metabolic, run by Charite University, Berlin, Germany at 1 site 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 2 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nadine Sylvester (+4930 80505 734, nadine.sylvester@immanuelalbertinen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exploratory Proteomics of Autophagy Processes I (time frame: change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jan 2024.