Fastreset Study: Metabolic Effects of a Five-day Remotely Delivered Hypocaloric and Ketogenic Program
NCT ID: NCT05821660
Last Updated: 2025-10-01
Study Results
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Basic Information
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COMPLETED
NA
64 participants
INTERVENTIONAL
2023-04-01
2023-08-17
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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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
Five-day hypocaloric and ketogenic programme
Dietary intervention
Control
The group will maintain their habitual diet
No interventions assigned to this group
Interventions
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Five-day hypocaloric and ketogenic programme
Dietary intervention
Other Intervention Names
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Eligibility Criteria
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Exclusion Criteria
* 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
18 Years
80 Years
ALL
Yes
Sponsors
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Buchinger Wilhelmi Clinic
UNKNOWN
King's College London
OTHER
MVZ Labor Ravensburg GbR
UNKNOWN
Synlab Málaga
UNKNOWN
Buchinger Wilhelmi Development & Holding GmbH
OTHER
Responsible Party
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Principal Investigators
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Françoise Wilhelmi de Toledo, Dr.
Role: PRINCIPAL_INVESTIGATOR
Buchinger Wilhelmi
Locations
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Buchinger Wilhelmi Clinic
Überlingen, Baden-Wurttemberg, Germany
Countries
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Other Identifiers
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F-2023-014
Identifier Type: -
Identifier Source: org_study_id
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