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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

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
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.

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Study Type : Observational
Estimated 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 : February 1, 2018
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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


Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. 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.


  5. 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.


Secondary Outcome Measures :
  1. Pain on Visual Analogue Scale (VAS) [ Time Frame: Change Baseline, 2 weeks, 3 months, 6 months, 12 months ]
    Questionnaire

  2. 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

  3. 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.

  4. 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

  5. Body-Mass-Index (BMI) [ Time Frame: Change Baseline, 2 weeks ]
    Anthropometry

  6. Blood pressure [ Time Frame: Change Baseline, 2 weeks ]
    Measuring systolic and diastolic blood pressure in mmHg

  7. 24h-Blood pressure [ Time Frame: Change Baseline, 2 weeks ]
    Measuring systolic and diastolic blood pressure with Device "Mobil-O-Graph"

  8. Blood count [ Time Frame: Change Baseline, 2 weeks ]
    Laboratory test

  9. Glomerular filtration rate (GFR) [ Time Frame: Change Baseline, 2 weeks ]
    Laboratory test

  10. 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)

  11. CRP [ Time Frame: Change Baseline, 2 weeks ]
    CRP in milligram per liter (mg/L)

  12. Liver enzymes (GOT, GPT) [ Time Frame: Change Baseline, 2 weeks ]
    Hepatic transaminases (GPT, GOT in U/L)

  13. Stepcounter [ Time Frame: Change Baseline, 2 weeks ]
    With Device "Everion"

  14. Heart Rate Variability [ Time Frame: Change Baseline, 2 weeks ]
    With Device "Faros 180"

  15. Heart Rate [ Time Frame: Change Baseline, 2 weeks ]
    With Device "Everion"

  16. Blood Oxygenation [ Time Frame: Change Baseline, 2 weeks ]
    With Device "Everion"


Biospecimen Retention:   Samples Without DNA
Blood, serum, urine


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Regular hospitalised patients
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03785197


Contacts
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Contact: Daniela Liebscher, Dr. 03080505770 daniela.liebscher@charite.de
Contact: Christian Kessler, Dr. 03080505691 christian.kessler@charite.de

Locations
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Germany
Immanuel Hospital Recruiting
Berlin-Wannsee, Berlin, Germany, 14109
Contact: Daniela Liebscher, Dr.    03080505770    daniela.liebscher@charite.de   
Contact: Christian Kessler, Dr.    03080505691    christian.kessler@charite.de   
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
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Principal Investigator: Andreas Michalsen, Prof. Dr. Study Principal Investigator

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Responsible Party: Andreas Michalsen, Principal Investigator, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT03785197     History of Changes
Other Study ID Numbers: FASTA
First Posted: December 24, 2018    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andreas Michalsen, Charite University, Berlin, Germany:
fasting
natural therapies
prolonged fasting
Additional relevant MeSH terms:
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Arthritis
Osteoarthritis
Arthritis, Rheumatoid
Fibromyalgia
Myofascial Pain Syndromes
Osteoarthritis, Knee
Osteoarthritis, Hip
Metabolic Syndrome
Syndrome
Disease
Pathologic Processes
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Muscular Diseases
Neuromuscular Diseases
Nervous System Diseases