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

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

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

Study Overview

• Status: Recruiting
• Conditions: Healthy Lifestyle; Healthy Nutrition
• Intervention / Treatment: Other: 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.

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Buchinger Wilhelmi Clinic; Phone Number: +49-7551-8070; Email: forschung@buchinger-wilhelmi.com
• Study Contact Backup: Name: Françoise Wilhelmi de Toledo, Dr.; Phone Number: +49-7551-8070; Email: francoise.wilhelmi@buchinger-wilhelmi.com

Study Locations

• Germany
  • Baden-Württemberg
    • Überlingen, Baden-Württemberg, Germany, 88662
      • Recruiting
      • Buchinger Wilhelmi Clinic
      • Contact: Françoise Wilhelmi de Toledo, Dr; Phone Number: 0049 7551 8070; Email: forschung@buchinger-wilhelmi.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: Five-day hypocaloric and ketogenic programme; Dietary intervention; Other Names: Buchinger Wilhelmi Fastingbox
No Intervention: Control; The group will maintain their habitual diet

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Buchinger Wilhelmi Development & Holding GmbH
• Collaborators: King's College London; Buchinger Wilhelmi Clinic; MVZ Labor Ravensburg GbR; Synlab Málaga
• Investigators: Principal Investigator: Françoise Wilhelmi de Toledo, Dr., Buchinger Wilhelmi

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Estimated): September 1, 2023
• Study Completion (Estimated): November 1, 2023

Study Registration Dates

• First Submitted: March 22, 2023
• First Submitted That Met QC Criteria: April 6, 2023
• First Posted (Actual): April 20, 2023

Study Record Updates

• Last Update Posted (Actual): August 2, 2023
• Last Update Submitted That Met QC Criteria: August 1, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: intestinal microbiota; inflammatory status; hypocaloric and ketogenic diet
• Other Study ID Numbers: F-2023-014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No