Fastreset Study: Metabolic Effects of a Five-day Remotely Delivered Hypocaloric and Ketogenic Program
- Conditions
- Healthy LifestyleHealthy Nutrition
- Interventions
- Other: Five-day hypocaloric and ketogenic programme
- Registration Number
- NCT05821660
- Lead Sponsor
- Buchinger Wilhelmi Development & Holding GmbH
- Brief Summary
The aim of this study is to assess changes in body and metabolism caused by this new five-day hypocaloric and ketogenic programme
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 64
Not provided
- Not able to sign the informed consent
- diagnosticated with cachexia, anorexia, nervosa, advanced kidney, liver or cerebrovascular insufficiency.
- Intake of antibiotics up to 2 months prior the study
- Medicated high blood pressure
- Diagnosed hyperuricemia
- Diagnosed diabetes mellitus type I and II
- Diagnosed kidney stone
- Active malignant diseases
- Known substance addiction
- Pregnancy or breastfeeding
- Participation in another study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Five-day hypocaloric and ketogenic programme Five-day hypocaloric and ketogenic programme The group will receive a five-day remotely delivered hypocaloric and ketogenic programme followed by a four-day food reintroduction period
- Primary Outcome Measures
Name Time Method Changes in body weight through study completion (11 subsequent days as well as one month afterwards) in kg
Changes in systolic blood pressure through study completion (11 subsequent days as well as one month afterwards) in mmHg
Changes in diastolic blood pressure through study completion (11 subsequent days as well as one month afterwards) in mmHg
- Secondary Outcome Measures
Name Time Method Changes in total cholesterol At baseline, after 5 and 9 days as well as 1 month afterwards measured in serum by a routine technique (photometry)
Changes in acetoacetic acid through study completion (11 subsequent days as well as one month afterwards) measured by nitroprussid test in urine in mg/dL
Changes in HDL-C At baseline, after 5 and 9 days as well as 1 month afterwards measured in serum by a routine technique (elimination/catalase)
Changes in ESR At baseline, after 5 and 9 days as well as 1 month afterwards measured in mm/h by kinetic flow analysis in capillaries on a photometric basis
Changes in triglycerides At baseline, after 5 and 9 days as well as 1 month afterwards measured in serum by a routine technique (GPO, trinder without serum blank) in mmol/l
Changes in HbA1c At baseline, after 5 and 9 days as well as 1 month afterwards measured in serum by a routine technique (HPLC) in %
Changes in Insulin At baseline, after 5 and 9 days as well as 1 month afterwards measured in serum by a routine technique (CLIA) in mU/l
Changes in gut microbiome composition At baseline, first stool after 9 days as well as 1 month afterwards Shotgun metagenomics, qPCR, SCFA
Changes in LDL-C At baseline, after 5 and 9 days as well as 1 month afterwards measured in serum by a routine technique (elimination/catalase)
Changes in lipidperoxidation At baseline, after 5 and 9 days as well as 1 month afterwards measured in serum by a routine technique (in µmol/l)
Changes in CRP At baseline, after 5 and 9 days as well as 1 month afterwards measured in serum by a routine technique
Changes in IL-10 At baseline, after 5 and 9 days as well as 1 month afterwards measured in serum by a routine technique
Changes in well-being through study completion (11 subsequent days as well as one month afterwards) WHO-5 well-being index
Changes in glucose At baseline, after 5 and 9 days as well as 1 month afterwards measured in serum by a routine technique (hexokinase) in mmol/l
Changes in total antioxidant capacity At baseline, after 5 and 9 days as well as 1 month afterwards measured in serum by a routine technique
Changes in IL-6 At baseline, after 5 and 9 days as well as 1 month afterwards measured in serum by a routine technique (ECLIA)
Changes in TNF-a At baseline, after 5 and 9 days as well as 1 month afterwards measured in serum by a routine technique (CLIA)
Trial Locations
- Locations (1)
Buchinger Wilhelmi Clinic
🇩🇪Überlingen, Baden-Württemberg, Germany