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

NCT ID: NCT05821660

Last Updated: 2025-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2023-08-17

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.

Conditions

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Healthy Nutrition Healthy Lifestyle

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, two-arm interventional study
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

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

Group Type EXPERIMENTAL

Five-day hypocaloric and ketogenic programme

Intervention Type OTHER

Dietary intervention

Control

The group will maintain their habitual diet

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Five-day hypocaloric and ketogenic programme

Dietary intervention

Intervention Type OTHER

Other Intervention Names

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Buchinger Wilhelmi Fastingbox

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Buchinger Wilhelmi Clinic

UNKNOWN

Sponsor Role collaborator

King's College London

OTHER

Sponsor Role collaborator

MVZ Labor Ravensburg GbR

UNKNOWN

Sponsor Role collaborator

Synlab Málaga

UNKNOWN

Sponsor Role collaborator

Buchinger Wilhelmi Development & Holding GmbH

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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Germany

Other Identifiers

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F-2023-014

Identifier Type: -

Identifier Source: org_study_id

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