AzTrials
AzTrials

Metabolic SyndromeFASTANCT03785197

Effects of a Clinical Dietary Intervention During Inpatient Treatment

An observational study of Metabolic Syndrome and Osteoarthritis, Hip, run by Charite University, Berlin, Germany at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
Prolonged modified fasting
How many people
500 participants
Where
1 siteGermany
Study dates
1 Feb 2018to 1 Mar 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Regular hospitalised patients

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Immanuel Hospital

    Wannsee, State of Berlin, 14109

Other trials in Germany

About this study

Official title: 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.

Read the detailed description

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.

Being tested
Prolonged modified fasting
Keywords
fasting, natural therapies, prolonged fasting
Medical subject headings
Metabolic Syndrome, Osteoarthritis, Hip, Osteoarthritis, Knee, Arthritis, Rheumatoid, Fibromyalgia, Fasting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prolonged modified fastingOther

    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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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

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

  3. 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

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

  4. 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.

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

  5. Summary of Diabetes Self Care Activities Measure (SDSCA)

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

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

Secondary outcomes (16)

  1. Pain on Visual Analogue Scale (VAS)

    Questionnaire

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

  2. Hospital Anxiety and Depression Scale (HADS)

    Questionnaire; HADS: Assessing full scale, range 0-42, lower score meaning a better outcome

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

  3. Perceived Stress Scale (PSS)

    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.

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

  4. Quality of Life (WHO-5)

    Questionnaire; Change from Baseline in the WHO-5, range from 0 to 100 % while higher values meaning a higher grade of well-being

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

  5. Body-Mass-Index (BMI)

    Anthropometry

    Measured: Change Baseline, 2 weeks

  6. Blood pressure

    Measuring systolic and diastolic blood pressure in mmHg

    Measured: Change Baseline, 2 weeks

  7. 24h-Blood pressure

    Measuring systolic and diastolic blood pressure with Device "Mobil-O-Graph"

    Measured: Change Baseline, 2 weeks

  8. Blood count

    Laboratory test

    Measured: Change Baseline, 2 weeks

  9. Glomerular filtration rate (GFR)

    Laboratory test

    Measured: Change Baseline, 2 weeks

  10. Blood lipids

    triglycerides (mmol/L), total cholesterol (mmol/L), LDL (mmol/L), HDL (mmol/L), fasting glucose (mmol/L)

    Measured: Change Baseline, 2 weeks

  11. CRP

    CRP in milligram per liter (mg/L)

    Measured: Change Baseline, 2 weeks

  12. Liver enzymes (GOT, GPT)

    Hepatic transaminases (GPT, GOT in U/L)

    Measured: Change Baseline, 2 weeks

  13. Stepcounter

    With Device "Everion"

    Measured: Change Baseline, 2 weeks

  14. Heart Rate Variability

    With Device "Faros 180"

    Measured: Change Baseline, 2 weeks

  15. Heart Rate

    With Device "Everion"

    Measured: Change Baseline, 2 weeks

  16. Blood Oxygenation

    With Device "Everion"

    Measured: Change Baseline, 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Dec 2018
  2. Study start1 Feb 2018
  3. Primary completion1 Mar 2022 (estimated)
  4. Study completion1 Mar 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03785197
Sponsor's protocol ID
FASTA
Acronym
FASTA
Status last verified
May 2021
First submitted
20 Dec 2018
Last updated
12 May 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38613092

Questions about this trial

What is this clinical trial studying?

An observational study of Metabolic Syndrome and Osteoarthritis, Hip, run by Charite University, Berlin, Germany at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fibromyalgia Impact Questionnaire (FIQ) (time frame: Change Baseline, 2 weeks, 3 months, 6 months, 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03785197, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in