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

10. mai 2021 oppdatert av: Andreas Michalsen, Charite University, Berlin, Germany

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.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Annen: Prolonged modified fasting

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Forventet)

500

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Tyskland
- Berlin
  - Berlin-Wannsee, Berlin, Tyskland, 14109
    - Immanuel Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 85 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

Regular hospitalised patients

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Fibromyalgia Impact Questionnaire (FIQ) Tidsramme: 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.	Change Baseline, 2 weeks, 3 months, 6 months, 12 months
Disease Activity Score 28 (DAS 28) Tidsramme: 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	Change Baseline, 2 weeks, 3 months, 6 months, 12 months
Health Assessment Questionnaire (HAQ) Tidsramme: 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	Change Baseline, 2 weeks, 3 months, 6 months, 12 months
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Tidsramme: 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.	Change Baseline, 2 weeks, 3 months, 6 months, 12 months
Summary of Diabetes Self Care Activities Measure (SDSCA) Tidsramme: Change Baseline, 2 weeks, 3 months, 6 months, 12 months	Questionnaire; 11 items with each item scored on a scale of 0-7.	Change Baseline, 2 weeks, 3 months, 6 months, 12 months

Sekundære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Pain on Visual Analogue Scale (VAS) Tidsramme: Change Baseline, 2 weeks, 3 months, 6 months, 12 months	Questionnaire	Change Baseline, 2 weeks, 3 months, 6 months, 12 months
Hospital Anxiety and Depression Scale (HADS) Tidsramme: Change Baseline, 2 weeks, 3 months, 6 months, 12 months	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) Tidsramme: 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.	Change Baseline, 2 weeks, 3 months, 6 months, 12 months
Quality of Life (WHO-5) Tidsramme: 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	Change Baseline, 2 weeks, 3 months, 6 months, 12 months
Body-Mass-Index (BMI) Tidsramme: Change Baseline, 2 weeks	Anthropometry	Change Baseline, 2 weeks
Blood pressure Tidsramme: Change Baseline, 2 weeks	Measuring systolic and diastolic blood pressure in mmHg	Change Baseline, 2 weeks
24h-Blood pressure Tidsramme: Change Baseline, 2 weeks	Measuring systolic and diastolic blood pressure with Device "Mobil-O-Graph"	Change Baseline, 2 weeks
Blood count Tidsramme: Change Baseline, 2 weeks	Laboratory test	Change Baseline, 2 weeks
Glomerular filtration rate (GFR) Tidsramme: Change Baseline, 2 weeks	Laboratory test	Change Baseline, 2 weeks
Blood lipids Tidsramme: Change Baseline, 2 weeks	triglycerides (mmol/L), total cholesterol (mmol/L), LDL (mmol/L), HDL (mmol/L), fasting glucose (mmol/L)	Change Baseline, 2 weeks
CRP Tidsramme: Change Baseline, 2 weeks	CRP in milligram per liter (mg/L)	Change Baseline, 2 weeks
Liver enzymes (GOT, GPT) Tidsramme: Change Baseline, 2 weeks	Hepatic transaminases (GPT, GOT in U/L)	Change Baseline, 2 weeks
Stepcounter Tidsramme: Change Baseline, 2 weeks	With Device "Everion"	Change Baseline, 2 weeks
Heart Rate Variability Tidsramme: Change Baseline, 2 weeks	With Device "Faros 180"	Change Baseline, 2 weeks
Heart Rate Tidsramme: Change Baseline, 2 weeks	With Device "Everion"	Change Baseline, 2 weeks
Blood Oxygenation Tidsramme: Change Baseline, 2 weeks	With Device "Everion"	Change Baseline, 2 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Charite University, Berlin, Germany

Etterforskere

Hovedetterforsker: Andreas Michalsen, Prof. Dr., study principal investigator

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. februar 2018

Primær fullføring (Forventet)

1. mars 2022

Studiet fullført (Forventet)

1. mars 2022

Datoer for studieregistrering

Først innsendt

20. desember 2018

Først innsendt som oppfylte QC-kriteriene