Clinical trial NCT03785197: Effects of a Clinical Dietary Intervention During Inpatient Treatment
Official title: Effects of a Clinical Dietary Intervention During Inpatient Treatment (Modified Fasting in Metabolic Syndrome, Osteoarthritis of the Hip or Knee, Rheumatoid Arthritis and Fibromyalgia)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metabolic Syndrome
Osteoarthritis, Hip
Osteoarthritis, Knee
Rheumatoid Arthritis
Fibromyalgia
Keywords: fasting
natural therapies
prolonged fasting
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2018-12-24
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Regular hospitalised patients

Brief summary: The purpose of the study is a scientific and prospective documentation of the clinical effects of an inpatient treatment at the Immanuel Hospital of Berlin, in the department for complementary and integrative medicine, with the use of a modified fasting regime. A pre- and post- as well as group comparisons are planned. Patients that are admitted to the inpatient department for metabolic syndrome, osteoarthritis of the hip or knee, rheumatoid arthritis and fibromyalgia will be enrolled in the study.

Detailed description: At the beginning, during and at the end of the treatment at the inpatient department routine blood parameters, anthropometric parameters and certain scores and parameters specific to the different conditions will be measured. Questionnaires will be filled out by patients before and after the treatment as well as 3, 6 and 12 months after leaving the inpatient department.

Eligibility criteria: Inclusion Criteria:

* The patient is consents to participating in the trial during the first 24h of his or her stay in the inpatient naturopathic department of the Immanuel Hospital.
* Written informed consent is given
* The referral diagnosis is one of the following: diabetes mellitus type 2/metabolic syndrome, osteoarthritis of the hip, osteoarthritis of the knee, rheumatoid arthritis, fibromyalgia.

Exclusion Criteria:

* Language barries to understanding the instructions of the study personnel
* Dementia or other strong cognitive impairment
* Pregnant or lactating women
* Taking part in another study at the same time

Primary outcomes:
measure: Fibromyalgia Impact Questionnaire (FIQ)
timeFrame: Change Baseline, 2 weeks, 3 months, 6 months, 12 months
measure: Disease Activity Score 28 (DAS 28)
timeFrame: Change Baseline, 2 weeks, 3 months, 6 months, 12 months
measure: Health Assessment Questionnaire (HAQ)
timeFrame: Change Baseline, 2 weeks, 3 months, 6 months, 12 months
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: Change Baseline, 2 weeks, 3 months, 6 months, 12 months
measure: Summary of Diabetes Self Care Activities Measure (SDSCA)
timeFrame: Change Baseline, 2 weeks, 3 months, 6 months, 12 months
Secondary outcomes:
measure: Pain on Visual Analogue Scale (VAS)
timeFrame: Change Baseline, 2 weeks, 3 months, 6 months, 12 months
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Change Baseline, 2 weeks, 3 months, 6 months, 12 months
measure: Perceived Stress Scale (PSS)
timeFrame: Change Baseline, 2 weeks, 3 months, 6 months, 12 months
measure: Quality of Life (WHO-5)
timeFrame: Change Baseline, 2 weeks, 3 months, 6 months, 12 months
measure: Body-Mass-Index (BMI)
timeFrame: Change Baseline, 2 weeks
measure: Blood pressure
timeFrame: Change Baseline, 2 weeks
measure: 24h-Blood pressure
timeFrame: Change Baseline, 2 weeks
measure: Blood count
timeFrame: Change Baseline, 2 weeks
measure: Glomerular filtration rate (GFR)
timeFrame: Change Baseline, 2 weeks
measure: Blood lipids
timeFrame: Change Baseline, 2 weeks
measure: CRP
timeFrame: Change Baseline, 2 weeks
measure: Liver enzymes (GOT, GPT)
timeFrame: Change Baseline, 2 weeks
measure: Stepcounter
timeFrame: Change Baseline, 2 weeks
measure: Heart Rate Variability
timeFrame: Change Baseline, 2 weeks
measure: Heart Rate
timeFrame: Change Baseline, 2 weeks
measure: Blood Oxygenation
timeFrame: Change Baseline, 2 weeks
Other outcomes:
Locations:
city: Berlin-Wannsee
country: Germany
facility: Immanuel Hospital
state: Berlin
Study officials:
affiliation: Study Principal Investigator
name: Andreas Michalsen, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: