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

10 de maio de 2021 atualizado por: 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.

Visão geral do estudo

Status

Ativo, não recrutando

Condições

Intervenção / Tratamento

Outro: Prolonged modified fasting

Descrição detalhada

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.

Tipo de estudo

Observacional

Inscrição (Antecipado)

500

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

Alemanha
- Berlin
  - Berlin-Wannsee, Berlin, Alemanha, 14109
    - Immanuel Hospital

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 85 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra de Probabilidade

População do estudo

Regular hospitalised patients

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Descrição da medida	Prazo
Fibromyalgia Impact Questionnaire (FIQ) Prazo: 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) Prazo: 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) Prazo: 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) Prazo: 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) Prazo: 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

Medidas de resultados secundários

Medida de resultado	Descrição da medida	Prazo
Pain on Visual Analogue Scale (VAS) Prazo: 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) Prazo: 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) Prazo: 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) Prazo: 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) Prazo: Change Baseline, 2 weeks	Anthropometry	Change Baseline, 2 weeks
Blood pressure Prazo: Change Baseline, 2 weeks	Measuring systolic and diastolic blood pressure in mmHg	Change Baseline, 2 weeks
24h-Blood pressure Prazo: Change Baseline, 2 weeks	Measuring systolic and diastolic blood pressure with Device "Mobil-O-Graph"	Change Baseline, 2 weeks
Blood count Prazo: Change Baseline, 2 weeks	Laboratory test	Change Baseline, 2 weeks
Glomerular filtration rate (GFR) Prazo: Change Baseline, 2 weeks	Laboratory test	Change Baseline, 2 weeks
Blood lipids Prazo: 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 Prazo: Change Baseline, 2 weeks	CRP in milligram per liter (mg/L)	Change Baseline, 2 weeks
Liver enzymes (GOT, GPT) Prazo: Change Baseline, 2 weeks	Hepatic transaminases (GPT, GOT in U/L)	Change Baseline, 2 weeks
Stepcounter Prazo: Change Baseline, 2 weeks	With Device "Everion"	Change Baseline, 2 weeks
Heart Rate Variability Prazo: Change Baseline, 2 weeks	With Device "Faros 180"	Change Baseline, 2 weeks
Heart Rate Prazo: Change Baseline, 2 weeks	With Device "Everion"	Change Baseline, 2 weeks
Blood Oxygenation Prazo: Change Baseline, 2 weeks	With Device "Everion"	Change Baseline, 2 weeks

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Charite University, Berlin, Germany

Investigadores

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

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de fevereiro de 2018

Conclusão Primária (Antecipado)

1 de março de 2022

Conclusão do estudo (Antecipado)

1 de março de 2022

Datas de inscrição no estudo

Enviado pela primeira vez

20 de dezembro de 2018

Enviado pela primeira vez que atendeu aos critérios de CQ