FASTA: Effects of a Clinical Dietary Intervention During Inpatient Treatment

Sponsor

Charite University, Berlin, Germany (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03785197

Collaborator

(none)

500

Enrollment

Location

48.9

Anticipated Duration (Months)

10.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metabolic Syndrome Osteoarthritis, Hip Osteoarthritis, Knee Rheumatoid Arthritis Fibromyalgia	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 Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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)

Actual Study Start Date :

Feb 1, 2018

Anticipated Primary Completion Date :

Mar 1, 2022

Anticipated Study Completion Date :

Mar 1, 2022

Outcome Measures

Primary Outcome Measures

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.
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
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
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.
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.

Secondary Outcome Measures

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.
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
Blood pressure [Change Baseline, 2 weeks]
Measuring systolic and diastolic blood pressure in mmHg
24h-Blood pressure [Change Baseline, 2 weeks]
Measuring systolic and diastolic blood pressure with Device "Mobil-O-Graph"
Blood count [Change Baseline, 2 weeks]
Laboratory test
Glomerular filtration rate (GFR) [Change Baseline, 2 weeks]
Laboratory test
Blood lipids [Change Baseline, 2 weeks]
triglycerides (mmol/L), total cholesterol (mmol/L), LDL (mmol/L), HDL (mmol/L), fasting glucose (mmol/L)
CRP [Change Baseline, 2 weeks]
CRP in milligram per liter (mg/L)
Liver enzymes (GOT, GPT) [Change Baseline, 2 weeks]
Hepatic transaminases (GPT, GOT in U/L)
Stepcounter [Change Baseline, 2 weeks]
With Device "Everion"
Heart Rate Variability [Change Baseline, 2 weeks]
With Device "Faros 180"
Heart Rate [Change Baseline, 2 weeks]
With Device "Everion"
Blood Oxygenation [Change Baseline, 2 weeks]
With Device "Everion"

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.