Effects of a Clinical Dietary Intervention During Inpatient Treatment

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of a Clinical Dietary Intervention During Inpatient Treatment (Modified Fasting in Metabolic Syndrome, Osteoarthritis of the Hip or Knee, Rheumatoid Arthritis and Fibromyalgia)

Conditions
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Fibromyalgia, Metabolic Syndrome, Osteoarthritis, Hip, Osteoarthritis, Knee, Rheumatoid Arthritis

Intervention / Treatment
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* Other: Prolonged modified fasting


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Prolonged modified fasting|The prolonged modified fasting is a dietary intervention with abstinence from solid foods and a caloric intake of 100-400 kcal through juices and vegetable broths|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fibromyalgia Impact Questionnaire (FIQ) | Questionnaire; The FIQ is scored in such a way that a higher score indicates a greater impact of the syndrome on the person. Each of the 10 items has a maximum possible score of 10. Thus the maximum possible score is 100. The average FM patient scores about 50, severely afflicted patients are usually 70 plus. | Change Baseline, 2 weeks, 3 months, 6 months, 12 months | 
| Disease Activity Score 28 (DAS 28) | Questionnaire with Clinical Examination; Change from Baseline in the DAS-28, range from 2.0 to 10.0 while higher values meaning a higher disease activity and below of 2.6 meaning remission | Change Baseline, 2 weeks, 3 months, 6 months, 12 months | 
| Health Assessment Questionnaire (HAQ) | Questionnaire; Change from Baseline in the HAQ, range from 0 to 3 while higher values meaning a higher grade of disability | Change Baseline, 2 weeks, 3 months, 6 months, 12 months | 
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | Questionnaire consisting of 24 items divided into 3 subscales: Pain (5items), Stiffness (2 items), Physical Function (17 items). The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Higher values meaning a higher grade of disability. | Change Baseline, 2 weeks, 3 months, 6 months, 12 months | 
| Summary of Diabetes Self Care Activities Measure (SDSCA) | Questionnaire; 11 items with each item scored on a scale of 0-7. | Change Baseline, 2 weeks, 3 months, 6 months, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain on Visual Analogue Scale (VAS) | Questionnaire | Change Baseline, 2 weeks, 3 months, 6 months, 12 months | 
| Hospital Anxiety and Depression Scale (HADS) | Questionnaire; HADS: Assessing full scale, range 0-42, lower score meaning a better outcome | Change Baseline, 2 weeks, 3 months, 6 months, 12 months | 
| Perceived Stress Scale (PSS) | Questionnaire; Change from Baseline in the PSS, 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. | Change Baseline, 2 weeks, 3 months, 6 months, 12 months | 
| Quality of Life (WHO-5) | Questionnaire; Change from Baseline in the WHO-5, range from 0 to 100 % while higher values meaning a higher grade of well-being | Change Baseline, 2 weeks, 3 months, 6 months, 12 months | 
| Body-Mass-Index (BMI) | Anthropometry | Change Baseline, 2 weeks | 
| Blood pressure | Measuring systolic and diastolic blood pressure in mmHg | Change Baseline, 2 weeks | 
| 24h-Blood pressure | Measuring systolic and diastolic blood pressure with Device Mobil-O-Graph | Change Baseline, 2 weeks | 
| Blood count | Laboratory test | Change Baseline, 2 weeks | 
| Glomerular filtration rate (GFR) | Laboratory test | Change Baseline, 2 weeks | 
| Blood lipids | triglycerides (mmol/L), total cholesterol (mmol/L), LDL (mmol/L), HDL (mmol/L), fasting glucose (mmol/L) | Change Baseline, 2 weeks | 
| CRP | CRP in milligram per liter (mg/L) | Change Baseline, 2 weeks | 
| Liver enzymes (GOT, GPT) | Hepatic transaminases (GPT, GOT in U/L) | Change Baseline, 2 weeks | 
| Stepcounter | With Device Everion | Change Baseline, 2 weeks | 
| Heart Rate Variability | With Device Faros 180 | Change Baseline, 2 weeks | 
| Heart Rate | With Device Everion | Change Baseline, 2 weeks | 
| Blood Oxygenation | With Device Everion | Change Baseline, 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fasting, natural therapies, prolonged fasting