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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
64
Dietary intervention
Buchinger Wilhelmi Clinic
Überlingen, Baden-Wurttemberg, Germany
Changes in body weight
in kg
Time frame: through study completion (11 subsequent days as well as one month afterwards)
Changes in systolic blood pressure
in mmHg
Time frame: through study completion (11 subsequent days as well as one month afterwards)
Changes in diastolic blood pressure
in mmHg
Time frame: through study completion (11 subsequent days as well as one month afterwards)
Changes in acetoacetic acid
measured by nitroprussid test in urine in mg/dL
Time frame: through study completion (11 subsequent days as well as one month afterwards)
Changes in total cholesterol
measured in serum by a routine technique (photometry)
Time frame: 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)
Time frame: 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)
Time frame: 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 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
Time frame: 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 %
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: At baseline, after 5 and 9 days as well as 1 month afterwards
Changes in well-being
WHO-5 well-being index
Time frame: 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
Time frame: At baseline, after 5 and 9 days as well as 1 month afterwards
Changes in CRP
measured in serum by a routine technique
Time frame: 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)
Time frame: At baseline, after 5 and 9 days as well as 1 month afterwards
Changes in IL-10
measured in serum by a routine technique
Time frame: 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)
Time frame: At baseline, after 5 and 9 days as well as 1 month afterwards
Changes in gut microbiome composition
Shotgun metagenomics, qPCR, SCFA
Time frame: At baseline, first stool after 9 days as well as 1 month afterwards