Effects of a Clinical Dietary Intervention During Inpatient Treatment

NCT ID: NCT03785197

Last Updated: 2021-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-01

Study Completion Date

2022-03-01

Brief Summary

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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

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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.

Conditions

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Metabolic Syndrome Osteoarthritis, Hip Osteoarthritis, Knee Rheumatoid Arthritis Fibromyalgia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Andreas Michalsen

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andreas Michalsen, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Study Principal Investigator

Locations

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Immanuel Hospital

Wannsee, State of Berlin, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 38613092 (View on PubMed)

Other Identifiers

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FASTA

Identifier Type: -

Identifier Source: org_study_id

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