E66 K76.0
Conditions
Interventions
Group 1: Study group: 14-day liver fasting based on Dr. Worm® and subsequent participation in the Bodymed program with additional administration of the dietary supplements HEPALEAN®, HEPABIOTIC®, SANA
Sponsors
Bodymed GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Body Mass Index = 30 kg/m²
Exclusion criteria
Exclusion criteria: BMI 2.0 mg/dl, GFR <60 ml/min, alcohol abuse (to rule out alcoholic fatty liver disease), use of known hepatotoxic drugs (such as tamoxifen, amiodarone), other liver diseases (hepatitis B, C, hemochromatosis, viral hepatitis); chronic inflammatory bowel disease (CED) (ulcerative colitis, Crohn's disease, collagenous and lymphocytic colitis), taking antibiotics within the last 4 weeks, untreated hypothyroidism, systemic diseases (especially rheumatic diseases, gout and diseases of the blood (anemia, leukemia, sickle cell anemia), the nervous system (Parkinson's disease, multiple sclerosis) and the muscles (muscular dystrophy), cancer, psychiatric diseases, pregnancy, lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| During the study period, examinations will be carried out at a total of four points in time, both in the study group and in the control group: At the beginning of the study, after 14 days, after 3 months (cross-over point) and after 6 months. Body weight, height (once at the beginning), body mass index (BMI) and waist circumference as well as body composition using the BIA method (mBCA 555 from seca) are recorded. Additionally, a blood sample and a stool examination are carried out at all times mentioned in order to determine the microbiota and associated parameters for intestinal health. In addition, at the times mentioned, existing illnesses and medication (after 14 days only in the study group after liver fasting based on Dr. Worm®) as well as well-being and the nutritional situation by means of a nutrition protocol are recorded at the times mentioned. Target criteria (especially in study group within 3 months (T2)) should be when using the named products: - Increase in the mucosal-sensitive microbiota (such as F. prausnitzii, Akkermansia muciniphila) with an increase in the formation of butyric acid (butyrate), which supports the integrity of the intestinal mucosa and the formation of new intestinal mucus. - Decrease in the permeability markers, if there were elevated values ??at the beginning (T0) (zonulin, a1-antitrypsin). - Improving, i.e. increasing, the diversity of the microbiota. | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement of parameters associated with fatty liver and blood lipids in the study group. Weight reduction as well as a decrease in fat mass and an increase in lean body mass, in particular the metabolically active mass (muscles) in both the study and the comparison group. | — |
Countries
Germany
Contacts
Public ContactMichaela Betz
Bodymed-Center Ommersheim
Outcome results
None listed