Effects of a Clinical Dietary Intervention During Inpatient Treatment (FASTA)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Rheumatoid Arthritis; Osteoarthritis, Knee; Metabolic Syndrome; Fibromyalgia; Osteoarthritis, Hip
• Intervention / Treatment: Other: Prolonged modified fasting

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 Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• Germany
  • Berlin
    • Berlin-Wannsee, Berlin, Germany, 14109
      • Immanuel Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Regular hospitalised patients

Description

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 Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Principal Investigator: Andreas Michalsen, Prof. Dr., Study Principal Investigator

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Anticipated): March 1, 2022
• Study Completion (Anticipated): March 1, 2022

Study Registration Dates

• First Submitted: December 20, 2018
• First Submitted That Met QC Criteria: December 20, 2018
• First Posted (Actual): December 24, 2018

Study Record Updates

• Last Update Posted (Actual): May 12, 2021
• Last Update Submitted That Met QC Criteria: May 10, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: fasting; natural therapies; prolonged fasting
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Nervous System Diseases; Immune System Diseases; Autoimmune Diseases; Disease; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Muscular Diseases; Neuromuscular Diseases; Insulin Resistance; Hyperinsulinism; Syndrome; Arthritis; Arthritis, Rheumatoid; Osteoarthritis; Osteoarthritis, Knee; Metabolic Syndrome; Fibromyalgia; Myofascial Pain Syndromes; Osteoarthritis, Hip
• Other Study ID Numbers: FASTA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No