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| Name | Class |
|---|---|
| Buchinger Wilhelmi Clinic | UNKNOWN |
| King's College London | OTHER |
| MVZ Labor Ravensburg GbR | UNKNOWN |
| Synlab Málaga |
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The aim of this study is to assess changes in body and metabolism caused by this new five-day hypocaloric and ketogenic programme
Therapeutic effects of fasting are increasingly documented. Recent studies on a cohort of subjects doing a long-term fasting lasting from 4 days to several weeks demonstrated beneficial effects on health and well-being. In recent studies on the therapeutic efficacy of the Buchinger Wilhelmi fasting program, long-term fasting significantly improved risk factors for a variety of chronic diseases including hypertension even in medicated subjects, liver steatosis, inflammation, oxidative stress and lipoprotein distribution.
There is an increasing demand for dietary interventions which can be delivered at home. This has been amplified by the Coronavirus-19 disease (COVID-19) pandemic during which many countries kept their population in lockdown at home in isolation. The COVID-19 pandemic has also influenced the lifestyle of individuals, with an increased consumption of unhealthy food and a sedentary behaviour resulting in mental (anxiety, depression, and others) and physical (weight gain, rise in blood pressure) health issues. In order to adapt to this new context, the Buchinger Wilhelmi Clinics have created a hypocaloric, ketogenic program with interval fasting.
The five-day programme is designed to be easily integrated into everyday life and can be applied several times a year. The programme is based on ready-to-eat soups made with locally sourced organic ingredients. The ingredients represent a total daily intake of around 600 kcal per day - with a high share of fats and a limited quantity of carbohydrates and proteins. Minerals and micronutrients used at the Buchinger Wilhelmi Clinics are also supplied. Although the comprehensive medical care and assistance offered at the clinics cannot be replicated, medical professionals are available to support the customers remotely.
The investigators hypothesise that the metabolic changes caused by this new five-day programme can be similar to a short-term fast. In order to test this hypothesis, the investigators will perform a two-arm randomized controlled trial in which a group of participants will perform the five-day Fastingbox programme and a group of participants will receive an eucaloric diet as a control group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Five-day hypocaloric and ketogenic programme | Experimental | The group will receive a five-day remotely delivered hypocaloric and ketogenic programme followed by a four-day food reintroduction period |
|
| Control | No Intervention | The group will maintain their habitual diet |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Five-day hypocaloric and ketogenic programme | Other | Dietary intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in body weight | in kg | through study completion (11 subsequent days as well as one month afterwards) |
| Changes in systolic blood pressure | in mmHg | through study completion (11 subsequent days as well as one month afterwards) |
| Changes in diastolic blood pressure | in mmHg | through study completion (11 subsequent days as well as one month afterwards) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in acetoacetic acid | measured by nitroprussid test in urine in mg/dL | through study completion (11 subsequent days as well as one month afterwards) |
| Changes in total cholesterol | measured in serum by a routine technique (photometry) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in body mass index | in kg/m² | through study completion (11 subsequent days as well as one month afterwards) |
| Changes in abdominal circumference | in cm |
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Françoise Wilhelmi de Toledo, Dr. | Buchinger Wilhelmi | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Buchinger Wilhelmi Clinic | Überlingen | Baden-Wurttemberg | 88662 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42226305 | Derived | Grundler F, Ducarmon QR, Holley A, Knufinke M, Strathmeyer S, Heelemann S, Geyer R, Martinez-Tellez B, MacArthur MR, Zeller G, Wilhelmi de Toledo F, Mesnage R. Health benefits of a five-day at-home modified fasting program: a randomised controlled trial. Genome Med. 2026 Jun 1;18(1):80. doi: 10.1186/s13073-026-01681-3. |
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| UNKNOWN |
Prospective, two-arm interventional study
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| At baseline, after 5 and 9 days as well as 1 month afterwards |
| Changes in HDL-C | measured in serum by a routine technique (elimination/catalase) | At baseline, after 5 and 9 days as well as 1 month afterwards |
| Changes in LDL-C | measured in serum by a routine technique (elimination/catalase) | At baseline, after 5 and 9 days as well as 1 month afterwards |
| Changes in triglycerides | measured in serum by a routine technique (GPO, trinder without serum blank) in mmol/l | At baseline, after 5 and 9 days as well as 1 month afterwards |
| Changes in glucose | measured in serum by a routine technique (hexokinase) in mmol/l | At baseline, after 5 and 9 days as well as 1 month afterwards |
| Changes in HbA1c | measured in serum by a routine technique (HPLC) in % | At baseline, after 5 and 9 days as well as 1 month afterwards |
| Changes in Insulin | measured in serum by a routine technique (CLIA) in mU/l | At baseline, after 5 and 9 days as well as 1 month afterwards |
| Changes in total antioxidant capacity | measured in serum by a routine technique | At baseline, after 5 and 9 days as well as 1 month afterwards |
| Changes in lipidperoxidation | measured in serum by a routine technique (in µmol/l) | At baseline, after 5 and 9 days as well as 1 month afterwards |
| Changes in well-being | WHO-5 well-being index | through study completion (11 subsequent days as well as one month afterwards) |
| Changes in ESR | measured in mm/h by kinetic flow analysis in capillaries on a photometric basis | At baseline, after 5 and 9 days as well as 1 month afterwards |
| Changes in CRP | measured in serum by a routine technique | At baseline, after 5 and 9 days as well as 1 month afterwards |
| Changes in IL-6 | measured in serum by a routine technique (ECLIA) | At baseline, after 5 and 9 days as well as 1 month afterwards |
| Changes in IL-10 | measured in serum by a routine technique | At baseline, after 5 and 9 days as well as 1 month afterwards |
| Changes in TNF-a | measured in serum by a routine technique (CLIA) | At baseline, after 5 and 9 days as well as 1 month afterwards |
| Changes in gut microbiome composition | Shotgun metagenomics, qPCR, SCFA | At baseline, first stool after 9 days as well as 1 month afterwards |
| through study completion (11 subsequent days as well as one month afterwards) |
| Changes in resting heart frequency | in beats/min | through study completion (11 subsequent days as well as one month afterwards) |
| Changes in leucocytes | measured in serum by a routine technique (electronic count) | At baseline, after 5 and 9 days as well as 1 month afterwards |
| Changes in erythrocytes | measured in serum by a routine technique (electronic count) | At baseline, after 5 and 9 days as well as 1 month afterwards |
| Changes in haemoglobin | measured in serum by a routine technique (photometry) | At baseline, after 5 and 9 days as well as 1 month afterwards |
| Changes in haematocrit | measured in serum by a routine technique (electronic count) | At baseline, after 5 and 9 days as well as 1 month afterwards |
| Changes in MCV | measured in serum by a routine technique (ELISA) | At baseline, after 5 and 9 days as well as 1 month afterwards |
| Changes in MCH | measured in serum by a routine technique | At baseline, after 5 and 9 days as well as 1 month afterwards |
| Changes in MCHC | measured in serum by a routine technique | At baseline, after 5 and 9 days as well as 1 month afterwards |
| Changes in thrombocytes | measured in serum by a routine technique (electronic count) | At baseline, after 5 and 9 days as well as 1 month afterwards |
| Changes in INR | measured in serum by a routine technique (coagulometry) in sec | At baseline, after 5 and 9 days as well as 1 month afterwards |
| Changes in PTT | measured in serum by a routine technique (coagulometry) in sec | At baseline, after 5 and 9 days as well as 1 month afterwards |
| Changes in kidney parameters | blood parameters: uric acid, urea, creatinine in mg/dl | At baseline, after 5 and 9 days as well as 1 month afterwards |
| Changes in uric acid | measured in serum by a routine technique (enzymatic/uricase/peroxidas) in mg/dl | At baseline, after 5 and 9 days as well as 1 month afterwards |
| Changes in urea | measured in serum by a routine technique (GLDH) in mg/dl | At baseline, after 5 and 9 days as well as 1 month afterwards |
| Changes in creatinine | measured in serum by a routine technique (creatininase) in mg/dl | At baseline, after 5 and 9 days as well as 1 month afterwards |
| Changes in GOT | measured in serum by a routine technique (IFCC method) in U/l | At baseline, after 5 and 9 days as well as 1 month afterwards |
| Changes in GPT | measured in serum by a routine technique (IFCC method) in U/l | At baseline, after 5 and 9 days as well as 1 month afterwards |
| Changes in GGT | measured in serum by a routine technique (IFCC modified) in U/l | At baseline, after 5 and 9 days as well as 1 month afterwards |
| Changes in AP | measured in serum by a routine technique in U/l | At baseline, after 5 and 9 days as well as 1 month afterwards |
| Changes in sodium | measured in serum by a routine technique (potentiometric, ISE) in mmol/l | At baseline, after 5 and 9 days as well as 1 month afterwards |
| Changes in potassium | measured in serum by a routine technique (potentiometric, ISE) in mmol/l | At baseline, after 5 and 9 days as well as 1 month afterwards |
| Changes in calcium | measured in serum by a routine technique (CPC) in mmol/l | At baseline, after 5 and 9 days as well as 1 month afterwards |
| Changes in magnesium | measured in serum by a routine technique (ICPMS) in mmol/l | At baseline, after 5 and 9 days as well as 1 month afterwards |
| Changes in continous glucose monitoring | glucose level in mg/dl | At baseline, after 5 and 9 days as well as 1 month afterwards |
| Changes in physical activity level | questionnaires: International Physical Activity Questionnaire (IPAQ) 150min./week of exercise is considered sufficient physical activity | At baseline, after 5 and 9 days as well as 1 month afterwards |
| Changes in sleep quality | questionnaires: Pittsburgh Sleep Quality Index (PSQI), score ranging from 0 to 21, where lower scores denote a healthier sleep quality | At baseline, after 5 and 9 days as well as 1 month afterwards |
| Changes in processed food consumption | questionnaire: highly processed food consumption (sQ-HPF) | At baseline, after 5 and 9 days as well as 1 month afterwards |
| Changes in physical well-being | measured by visual scale (0-10) | through study completion (11 subsequent days as well as one month afterwards) |
| Changes in emotional well-being | measured by visual scale (0-10) | through study completion (11 subsequent days as well as one month afterwards) |
| Changes in energy level | measured by visual scale (0-10) | through study completion (11 subsequent days as well as one month afterwards) |
| Changes in cravings | measured by visual scale (0-10) | through study completion (11 subsequent days as well as one month afterwards) |
| Changes in feeling bloated | measured by visual scale (0-10) | through study completion (11 subsequent days as well as one month afterwards) |
| Changes in feeling cold | measured by visual scale (0-10) | through study completion (11 subsequent days as well as one month afterwards) |
| Changes in tiredness | measured by visual scale (0-10) | through study completion (11 subsequent days as well as one month afterwards) |
| Changes in muscle weakness | measured by visual scale (0-10) | through study completion (11 subsequent days as well as one month afterwards) |
| Changes in back pain | measured by visual scale (0-10) | through study completion (11 subsequent days as well as one month afterwards) |
| Changes in headache | measured by visual scale (0-10) | through study completion (11 subsequent days as well as one month afterwards) |
| Changes in hunger | measured by visual scale (0-10) | through study completion (11 subsequent days as well as one month afterwards) |
| Changes in anxiety | measured by visual scale (0-10) | through study completion (11 subsequent days as well as one month afterwards9 |
| Changes in digestive problems | measured by visual scale (0-10) | through study completion (11 subsequent days as well as one month afterwards) |
| Changes in optimism | measured by visual scale (0-4) | through study completion (11 subsequent days as well as one month afterwards) |
| Changes in relaxation | measured by visual scale (0-4) | through study completion (11 subsequent days as well as one month afterwards) |
| Changes in clear thinking | measured by visual scale (0-4) | through study completion (11 subsequent days as well as one month afterwards) |
| Changes in confidence | measured by visual scale (0-4) | through study completion (11 subsequent days as well as one month afterwards) |
| Changes in happiness | measured by visual scale (0-4) | through study completion (11 subsequent days as well as one month afterwards) |
| Changes in physical activity | measured by visual scale (0-10) and absolut numbers | through study completion (11 subsequent days as well as one month afterwards) |
| Ethnicity | Caucasian, Hispanic, African American, Asian, others | baseline |
| Smoking | status: never, former, current, flatmate | baseline |
| Alcohol consumption | number of glasses: wine, beer, spirits | baseline, after 5 and 9 days as well as 1 month afterwards |
| Changes in stress level | measured by visual scale (0-10) | baseline, after 5 and 9 days as well as 1 month afterwards |
| Changes in energy level | measured by visual scale (0-10) | baseline, after 5 and 9 days as well as 1 month afterwards |
| Changes in pain level | measured by visual scale (0-10) | baseline, after 5 and 9 days as well as 1 month afterwards |