Fastreset Study: Metabolic Effects of a Five-day Remotely Delivered Hypocaloric and Ketogenic Program

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Metabolic Effects of a Five-day Remotely Delivered Hypocaloric and Ketogenic Program in Healthy Subjects

Conditions
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Healthy Nutrition, Healthy Lifestyle

Intervention / Treatment
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* Other: Five-day hypocaloric and ketogenic programme


Participation Criteria
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Eligibility Criteria
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Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, two-arm interventional study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Five-day hypocaloric and ketogenic programme<br>The group will receive a five-day remotely delivered hypocaloric and ketogenic programme followed by a four-day food reintroduction period | Other: Five-day hypocaloric and ketogenic programme<br>* Dietary intervention<br>* Other names: Buchinger Wilhelmi Fastingbox;|
| No Intervention: Control<br>The group will maintain their habitual diet | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypocaloric and ketogenic diet, intestinal microbiota, inflammatory status