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

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ClinicalTrials.gov Identifier: NCT03785197
Recruitment Status : Recruiting
First Posted : December 24, 2018
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
Andreas Michalsen, Charite University, Berlin, Germany

Tracking Information
First Submitted Date December 20, 2018
First Posted Date December 24, 2018
Last Update Posted Date May 14, 2019
Actual Study Start Date February 1, 2018
Estimated Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 10, 2019)
  • Fibromyalgia Impact Questionnaire (FIQ) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: Change Baseline, 2 weeks, 3 months, 6 months, 12 months ]
    Questionnaire; 11 items with each item scored on a scale of 0-7.
Original Primary Outcome Measures
 (submitted: December 20, 2018)
  • Fibromyalgia Impact Questionnaire (FIQ) [ Time Frame: Change Baseline, 2 weeks, 3 months, 6 months, 12 months ]
  • Disease Activity Score 28 (DAS 28) [ Time Frame: Change Baseline, 2 weeks, 3 months, 6 months, 12 months ]
  • Health Assessment Questionnaire (HAQ) [ Time Frame: Change Baseline, 2 weeks, 3 months, 6 months, 12 months ]
  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: Change Baseline, 2 weeks, 3 months, 6 months, 12 months ]
  • Summary of Diabetes Self Care Activities Measure (SDSCA) [ Time Frame: Change Baseline, 2 weeks, 3 months, 6 months, 12 months ]
Change History Complete list of historical versions of study NCT03785197 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 10, 2019)
  • Pain on Visual Analogue Scale (VAS) [ Time Frame: Change Baseline, 2 weeks, 3 months, 6 months, 12 months ]
    Questionnaire
  • Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: Change Baseline, 2 weeks ]
    Anthropometry
  • Blood pressure [ Time Frame: Change Baseline, 2 weeks ]
    Measuring systolic and diastolic blood pressure in mmHg
  • 24h-Blood pressure [ Time Frame: Change Baseline, 2 weeks ]
    Measuring systolic and diastolic blood pressure with Device "Mobil-O-Graph"
  • Blood count [ Time Frame: Change Baseline, 2 weeks ]
    Laboratory test
  • Glomerular filtration rate (GFR) [ Time Frame: Change Baseline, 2 weeks ]
    Laboratory test
  • Blood lipids [ Time Frame: Change Baseline, 2 weeks ]
    triglycerides (mmol/L), total cholesterol (mmol/L), LDL (mmol/L), HDL (mmol/L), fasting glucose (mmol/L)
  • CRP [ Time Frame: Change Baseline, 2 weeks ]
    CRP in milligram per liter (mg/L)
  • Liver enzymes (GOT, GPT) [ Time Frame: Change Baseline, 2 weeks ]
    Hepatic transaminases (GPT, GOT in U/L)
  • Stepcounter [ Time Frame: Change Baseline, 2 weeks ]
    With Device "Everion"
  • Heart Rate Variability [ Time Frame: Change Baseline, 2 weeks ]
    With Device "Faros 180"
  • Heart Rate [ Time Frame: Change Baseline, 2 weeks ]
    With Device "Everion"
  • Blood Oxygenation [ Time Frame: Change Baseline, 2 weeks ]
    With Device "Everion"
Original Secondary Outcome Measures
 (submitted: December 20, 2018)
  • Pain on Visual Analogue Scale (VAS) [ Time Frame: Change Baseline, 2 weeks, 3 months, 6 months, 12 months ]
  • Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Change Baseline, 2 weeks, 3 months, 6 months, 12 months ]
  • Perceived Stress Scale (PSS) [ Time Frame: Change Baseline, 2 weeks, 3 months, 6 months, 12 months ]
  • Quality of Life (WHO-5) [ Time Frame: Change Baseline, 2 weeks, 3 months, 6 months, 12 months ]
  • Body-Mass-Index (BMI) [ Time Frame: Change Baseline, 2 weeks ]
  • Blood pressure [ Time Frame: Change Baseline, 2 weeks ]
  • 24h-Blood pressure [ Time Frame: Change Baseline, 2 weeks ]
    With Device "Mobil-O-Graph"
  • Blood count [ Time Frame: Change Baseline, 2 weeks ]
  • Glomerular filtration rate (GFR) [ Time Frame: Change Baseline, 2 weeks ]
  • Blood lipids [ Time Frame: Change Baseline, 2 weeks ]
  • CRP [ Time Frame: Change Baseline, 2 weeks ]
  • Liver enzymes (GOT, GPT) [ Time Frame: Change Baseline, 2 weeks ]
  • Stepcounter [ Time Frame: Change Baseline, 2 weeks ]
    With Device "Everion"
  • Heart Rate Variability [ Time Frame: Change Baseline, 2 weeks ]
    With Device "Faros 180"
  • Heart Rate [ Time Frame: Change Baseline, 2 weeks ]
    With Device "Everion"
  • Blood Oxygenation [ Time Frame: Change Baseline, 2 weeks ]
    With Device "Everion"
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effects of a Clinical Dietary Intervention During Inpatient Treatment
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)
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Blood, serum, urine
Sampling Method Probability Sample
Study Population Regular hospitalised patients
Condition
  • Metabolic Syndrome
  • Osteoarthritis, Hip
  • Osteoarthritis, Knee
  • Rheumatoid Arthritis
  • Fibromyalgia
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
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 20, 2018)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 1, 2020
Estimated Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Daniela Liebscher, Dr. 03080505770 daniela.liebscher@charite.de
Contact: Christian Kessler, Dr. 03080505691 christian.kessler@charite.de
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT03785197
Other Study ID Numbers FASTA
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Andreas Michalsen, Charite University, Berlin, Germany
Study Sponsor Charite University, Berlin, Germany
Collaborators Not Provided
Investigators
Principal Investigator: Andreas Michalsen, Prof. Dr. Study Principal Investigator
PRS Account Charite University, Berlin, Germany
Verification Date May 2019