Effects of a Clinical Dietary Intervention During Inpatient Treatment

NCT03785197 | Unknown

• 1 other identifier: FASTA
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome; Osteoarthritis, Hip; Osteoarthritis, Knee; Rheumatoid Arthritis; Fibromyalgia

Keywords

fasting; natural therapies; prolonged fasting

Outcome Measures

Primary Outcomes (5)

• Fibromyalgia Impact Questionnaire (FIQ)

  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)

  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)

  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)

  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)

  Questionnaire; 11 items with each item scored on a scale of 0-7.

  Change Baseline, 2 weeks, 3 months, 6 months, 12 months

Secondary Outcomes (16)

• Pain on Visual Analogue Scale (VAS)

  Change Baseline, 2 weeks, 3 months, 6 months, 12 months

• Hospital Anxiety and Depression Scale (HADS)

  Change Baseline, 2 weeks, 3 months, 6 months, 12 months

• Perceived Stress Scale (PSS)

  Change Baseline, 2 weeks, 3 months, 6 months, 12 months

• Quality of Life (WHO-5)

  Change Baseline, 2 weeks, 3 months, 6 months, 12 months

• Body-Mass-Index (BMI)

  Change Baseline, 2 weeks

Interventions

Prolonged modified fasting OTHER

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

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Regular hospitalised patients

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Immanuel Hospital

Wannsee, State of Berlin, 14109, Germany

Location

Related Publications (1)

• Koppold DA, Kandil FI, Muller A, Guttler O, Steckhan N, Meiss S, Breinlinger C, Nelle E, Rajput Khokhar A, Jeitler M, Hanslian E, Fischer JM, Michalsen A, Kessler CS. Effects of Prolonged Medical Fasting during an Inpatient, Multimodal, Nature-Based Treatment on Pain, Physical Function, and Psychometric Parameters in Patients with Fibromyalgia: An Observational Study. Nutrients. 2024 Apr 4;16(7):1059. doi: 10.3390/nu16071059.

  PMID: 38613092 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood, serum, urine

MeSH Terms

Conditions

Metabolic Syndrome; Osteoarthritis, Hip; Osteoarthritis, Knee; Arthritis, Rheumatoid; Fibromyalgia; Fasting

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Muscular Diseases; Neuromuscular Diseases; Nervous System Diseases; Feeding Behavior; Behavior

Study Officials

• Andreas Michalsen, Prof. Dr.

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 20, 2018
• First Posted: December 24, 2018
• Study Start: February 1, 2018
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: May 12, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)