Effects of a Clinical Dietary Intervention During Inpatient Treatment

• Conditions: Rheumatoid Arthritis; Osteoarthritis, Hip; Osteoarthritis, Knee; Fibromyalgia; Metabolic Syndrome

• Registration Number: NCT03785197
• Lead Sponsor: Charite University, Berlin, Germany

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.

Study Timeline

• Study Start: 2018-02-01
• Study First Submitted: 2018-12-20
• Study First Submitted QC: 2018-12-20
• Study First Posted: 2018-12-24
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-10
• Last Update Posted: 2021-05-12
• Primary Completion: 2022-03-01
• Study Completion: 2022-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Health Assessment Questionnaire (HAQ)	Change Baseline, 2 weeks, 3 months, 6 months, 12 months	Questionnaire; Change from Baseline in the HAQ, range from 0 to 3 while higher values meaning a higher grade of disability
Disease Activity Score 28 (DAS 28)	Change Baseline, 2 weeks, 3 months, 6 months, 12 months	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
Summary of Diabetes Self Care Activities Measure (SDSCA)	Change Baseline, 2 weeks, 3 months, 6 months, 12 months	Questionnaire; 11 items with each item scored on a scale of 0-7.
Fibromyalgia Impact Questionnaire (FIQ)	Change Baseline, 2 weeks, 3 months, 6 months, 12 months	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.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	Change Baseline, 2 weeks, 3 months, 6 months, 12 months	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Immanuel Hospital; 🇩🇪 Berlin-Wannsee, Berlin, Germany