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

Healthy Lifestyle Clinical Trial

— Fastreset  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05821660
• Other study ID #: F-2023-014
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: November 2023

Study information

• Verified date: August 2023
• Source: Buchinger Wilhelmi Development & Holding GmbH
• Contact: Buchinger Wilhelmi Clinic
• Phone: +49-7551-8070
• Email: forschung[@]buchinger-wilhelmi.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to assess changes in body and metabolism caused by this new five-day hypocaloric and ketogenic programme

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 information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: November 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Lifestyle

Intervention

Other:
• Five-day hypocaloric and ketogenic programme
Dietary intervention

Locations

Country	Name	City	State
Germany	Buchinger Wilhelmi Clinic	Überlingen	Baden-Württemberg

Sponsors (5)

Lead Sponsor	Collaborator
Buchinger Wilhelmi Development & Holding GmbH	Buchinger Wilhelmi Clinic, King's College London, MVZ Labor Ravensburg GbR, Synlab Málaga

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in body mass index	in kg/m²	through study completion (11 subsequent days as well as one month afterwards)
Other	Changes in abdominal circumference	in cm	through study completion (11 subsequent days as well as one month afterwards)
Other	Changes in resting heart frequency	in beats/min	through study completion (11 subsequent days as well as one month afterwards)
Other	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
Other	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
Other	Changes in haemoglobin	measured in serum by a routine technique (photometry)	At baseline, after 5 and 9 days as well as 1 month afterwards
Other	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
Other	Changes in MCV	measured in serum by a routine technique (ELISA)	At baseline, after 5 and 9 days as well as 1 month afterwards
Other	Changes in MCH	measured in serum by a routine technique	At baseline, after 5 and 9 days as well as 1 month afterwards
Other	Changes in MCHC	measured in serum by a routine technique	At baseline, after 5 and 9 days as well as 1 month afterwards
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	Changes in continous glucose monitoring	glucose level in mg/dl	At baseline, after 5 and 9 days as well as 1 month afterwards
Other	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
Other	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
Other	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
Other	Changes in physical well-being	measured by visual scale (0-10)	through study completion (11 subsequent days as well as one month afterwards)
Other	Changes in emotional well-being	measured by visual scale (0-10)	through study completion (11 subsequent days as well as one month afterwards)
Other	Changes in energy level	measured by visual scale (0-10)	through study completion (11 subsequent days as well as one month afterwards)
Other	Changes in cravings	measured by visual scale (0-10)	through study completion (11 subsequent days as well as one month afterwards)
Other	Changes in feeling bloated	measured by visual scale (0-10)	through study completion (11 subsequent days as well as one month afterwards)
Other	Changes in feeling cold	measured by visual scale (0-10)	through study completion (11 subsequent days as well as one month afterwards)
Other	Changes in tiredness	measured by visual scale (0-10)	through study completion (11 subsequent days as well as one month afterwards)
Other	Changes in muscle weakness	measured by visual scale (0-10)	through study completion (11 subsequent days as well as one month afterwards)
Other	Changes in back pain	measured by visual scale (0-10)	through study completion (11 subsequent days as well as one month afterwards)
Other	Changes in headache	measured by visual scale (0-10)	through study completion (11 subsequent days as well as one month afterwards)
Other	Changes in hunger	measured by visual scale (0-10)	through study completion (11 subsequent days as well as one month afterwards)
Other	Changes in anxiety	measured by visual scale (0-10)	through study completion (11 subsequent days as well as one month afterwards9
Other	Changes in digestive problems	measured by visual scale (0-10)	through study completion (11 subsequent days as well as one month afterwards)
Other	Changes in optimism	measured by visual scale (0-4)	through study completion (11 subsequent days as well as one month afterwards)
Other	Changes in relaxation	measured by visual scale (0-4)	through study completion (11 subsequent days as well as one month afterwards)
Other	Changes in clear thinking	measured by visual scale (0-4)	through study completion (11 subsequent days as well as one month afterwards)
Other	Changes in confidence	measured by visual scale (0-4)	through study completion (11 subsequent days as well as one month afterwards)
Other	Changes in happiness	measured by visual scale (0-4)	through study completion (11 subsequent days as well as one month afterwards)
Other	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)
Other	Ethnicity	Caucasian, Hispanic, African American, Asian, others	baseline
Other	Smoking	status: never, former, current, flatmate	baseline
Other	Alcohol consumption	number of glasses: wine, beer, spirits	baseline, after 5 and 9 days as well as 1 month afterwards
Other	Changes in stress level	measured by visual scale (0-10)	baseline, after 5 and 9 days as well as 1 month afterwards
Other	Changes in energy level	measured by visual scale (0-10)	baseline, after 5 and 9 days as well as 1 month afterwards
Other	Changes in pain level	measured by visual scale (0-10)	baseline, after 5 and 9 days as well as 1 month afterwards
Primary	Changes in body weight	in kg	through study completion (11 subsequent days as well as one month afterwards)
Primary	Changes in systolic blood pressure	in mmHg	through study completion (11 subsequent days as well as one month afterwards)
Primary	Changes in diastolic blood pressure	in mmHg	through study completion (11 subsequent days as well as one month afterwards)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Changes in well-being	WHO-5 well-being index	through study completion (11 subsequent days as well as one month afterwards)
Secondary	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
Secondary	Changes in CRP	measured in serum by a routine technique	At baseline, after 5 and 9 days as well as 1 month afterwards
Secondary	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
Secondary	Changes in IL-10	measured in serum by a routine technique	At baseline, after 5 and 9 days as well as 1 month afterwards
Secondary	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
Secondary	Changes in gut microbiome composition	Shotgun metagenomics, qPCR, SCFA	At baseline, first stool after 9 days as well as 1 month afterwards