NCT02113111

Brief Summary

The study aims to investigate

  • if a 7 day therapeutic fasting regimen will affect self-efficacy of patients with chronic diseases
  • the effects of fasting on physical and mental well-being, quality of life and body awareness/image
  • the association between patients characteristics and the perceived health benefit after fasting
  • the association between Diagnosis according to traditional Chinese medicine and physical and mental well-being during the course of fasting
  • experiences and perceptions of patients during fasting therapy

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

April 10, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 14, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

September 4, 2015

Status Verified

September 1, 2015

Enrollment Period

1.2 years

First QC Date

April 10, 2014

Last Update Submit

September 3, 2015

Conditions

Outcome Measures

Primary Outcomes (2)

  • Self efficacy questionnaire

    Self efficacy questionnaire (SWE) by Schwarzer and Jerusalem, 1999

    up to 6 months

  • Bodily self-efficacy

    Bodily self-efficacy (Schützler and Witt, 2013)

    up to 6 months

Secondary Outcomes (9)

  • Ability and will to change

    2 weeks, 6 months

  • Easiness of life

    2 weeks, 6 months

  • Health-related quality of life

    2 weeks, 6 months

  • Body responsiveness

    2 weeks, 6 months

  • Body awareness and dissociation

    2 weeks, 6 months

  • +4 more secondary outcomes

Other Outcomes (3)

  • Well-being

    2 weeks

  • Diagnosis according to traditional Chinese medicine

    day 1

  • Experiences

    2 weeks

Study Arms (1)

Fasting

Patients being admitted to an internal integrative medicine hospital and referred to therapeutic fasting therapy

Behavioral: Fasting

Interventions

FastingBEHAVIORAL

Fasting therapy was adapted from Buchinger, including a fasting period of 7 days. After 2 prefasting days with 800kcal per day from vegetables and rice/potatoes, fasting starts with the ingestion of an oral laxative. During fasting patients receive small quantities of juice and herbal teas, and a vegetable broth for lunch, altogether no more than 350kcal per day. At the end, fasting is broken by an apple or cooked potato, and for the following 3 days nutrition returns to normocaloric diet.

Fasting

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients being treated in an integrative clinic for internal medicine Patients recommended for fasting therapy during the inpatient treatment

You may qualify if:

  • years or older
  • eligible for fasting, i.e. normal weight (no anorexia, no nutritional deficiency, no BMI\<18 or \>35, no eating disorder)

You may not qualify if:

  • psychiatric disorder
  • type 1 diabetes
  • hepatitis
  • severe somatic disorder (oncological disease, hepatological or nephrological)
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Internal and Integrative Medicine, Kliniken Essen-Mitte

Essen, 45276, Germany

Location

Related Links

MeSH Terms

Conditions

Chronic PainFibromyalgiaArthritis, RheumatoidGoutHeadacheArthritisGastrointestinal DiseasesIrritable Bowel SyndromeInflammatory Bowel DiseasesCardiovascular Diseases

Interventions

Angptl4 protein, mouse

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesJoint DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesCrystal ArthropathiesPurine-Pyrimidine Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic DiseasesDigestive System DiseasesColonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastroenteritis

Study Officials

  • Gustav Dobos, Prof

    Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen

    STUDY DIRECTOR
  • Romy Lauche, PhD

    Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen

    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

April 10, 2014

First Posted

April 14, 2014

Study Start

April 1, 2014

Primary Completion

July 1, 2015

Study Completion

September 1, 2015

Last Updated

September 4, 2015

Record last verified: 2015-09

Locations