Effects of a Clinical Dietary Intervention During Inpatient Treatment

Rheumatoid Arthritis Clinical Trial

— FASTA  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03785197
• Other study ID #: FASTA
• Status: Active, not recruiting
• Start date: February 1, 2018
• Est. completion date: March 1, 2022

Study information

• Verified date: May 2021
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: March 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Fibromyalgia
• Metabolic Syndrome
• Myofascial Pain Syndromes
• Osteoarthritis
• Osteoarthritis, Hip
• Osteoarthritis, Knee
• Rheumatoid Arthritis
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Germany	Immanuel Hospital	Berlin-Wannsee	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Pain on Visual Analogue Scale (VAS)	Questionnaire	Change Baseline, 2 weeks, 3 months, 6 months, 12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Body-Mass-Index (BMI)	Anthropometry	Change Baseline, 2 weeks
Secondary	Blood pressure	Measuring systolic and diastolic blood pressure in mmHg	Change Baseline, 2 weeks
Secondary	24h-Blood pressure	Measuring systolic and diastolic blood pressure with Device "Mobil-O-Graph"	Change Baseline, 2 weeks
Secondary	Blood count	Laboratory test	Change Baseline, 2 weeks
Secondary	Glomerular filtration rate (GFR)	Laboratory test	Change Baseline, 2 weeks
Secondary	Blood lipids	triglycerides (mmol/L), total cholesterol (mmol/L), LDL (mmol/L), HDL (mmol/L), fasting glucose (mmol/L)	Change Baseline, 2 weeks
Secondary	CRP	CRP in milligram per liter (mg/L)	Change Baseline, 2 weeks
Secondary	Liver enzymes (GOT, GPT)	Hepatic transaminases (GPT, GOT in U/L)	Change Baseline, 2 weeks
Secondary	Stepcounter	With Device "Everion"	Change Baseline, 2 weeks
Secondary	Heart Rate Variability	With Device "Faros 180"	Change Baseline, 2 weeks
Secondary	Heart Rate	With Device "Everion"	Change Baseline, 2 weeks
Secondary	Blood Oxygenation	With Device "Everion"	Change Baseline, 2 weeks