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Healthy NutritionFastresetNCT05821660

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

A study testing Five-day hypocaloric and ketogenic programme in people with Healthy Nutrition and Healthy Lifestyle, run by Buchinger Wilhelmi Development & Holding GmbH at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Nutrition, Healthy Lifestyle
What is being tested?
Five-day hypocaloric and ketogenic programme
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
1 siteGermany
Study dates
1 Apr 2023to 17 Aug 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • 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
Show all 11Show fewer
  • Diagnosed kidney stone
  • Active malignant diseases
  • Known substance addiction
  • Pregnancy or breastfeeding
  • Participation in another study

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Buchinger Wilhelmi Clinic

    Überlingen, Baden-Wurttemberg, 88662

Other trials in Germany

About this study

Official title: 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

Read the 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.

Being tested
Five-day hypocaloric and ketogenic programme
Keywords
hypocaloric and ketogenic diet, intestinal microbiota, inflammatory status

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Five-day hypocaloric and ketogenic programmeOther

    Also called Buchinger Wilhelmi Fastingbox

    Dietary intervention

Study groups in NCT05821660
Study groupRoleWhat they receive
Five-day hypocaloric and ketogenic programmeExperimentalThe group will receive a five-day remotely delivered hypocaloric and ketogenic programme followed by a four-day food reintroduction period
Receives: Other: Five-day hypocaloric and ketogenic programme
ControlNo interventionThe group will maintain their habitual diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in body weight

    in kg

    Measured: through study completion (11 subsequent days as well as one month afterwards)

  2. Changes in systolic blood pressure

    in mmHg

    Measured: through study completion (11 subsequent days as well as one month afterwards)

  3. Changes in diastolic blood pressure

    in mmHg

    Measured: through study completion (11 subsequent days as well as one month afterwards)

Secondary outcomes (17)

  1. Changes in acetoacetic acid

    measured by nitroprussid test in urine in mg/dL

    Measured: through study completion (11 subsequent days as well as one month afterwards)

  2. Changes in total cholesterol

    measured in serum by a routine technique (photometry)

    Measured: At baseline, after 5 and 9 days as well as 1 month afterwards

  3. Changes in HDL-C

    measured in serum by a routine technique (elimination/catalase)

    Measured: At baseline, after 5 and 9 days as well as 1 month afterwards

  4. Changes in LDL-C

    measured in serum by a routine technique (elimination/catalase)

    Measured: At baseline, after 5 and 9 days as well as 1 month afterwards

  5. Changes in triglycerides

    measured in serum by a routine technique (GPO, trinder without serum blank) in mmol/l

    Measured: At baseline, after 5 and 9 days as well as 1 month afterwards

  6. Changes in glucose

    measured in serum by a routine technique (hexokinase) in mmol/l

    Measured: At baseline, after 5 and 9 days as well as 1 month afterwards

  7. Changes in HbA1c

    measured in serum by a routine technique (HPLC) in %

    Measured: At baseline, after 5 and 9 days as well as 1 month afterwards

  8. Changes in Insulin

    measured in serum by a routine technique (CLIA) in mU/l

    Measured: At baseline, after 5 and 9 days as well as 1 month afterwards

  9. Changes in total antioxidant capacity

    measured in serum by a routine technique

    Measured: At baseline, after 5 and 9 days as well as 1 month afterwards

  10. Changes in lipidperoxidation

    measured in serum by a routine technique (in µmol/l)

    Measured: At baseline, after 5 and 9 days as well as 1 month afterwards

  11. Changes in well-being

    WHO-5 well-being index

    Measured: through study completion (11 subsequent days as well as one month afterwards)

  12. Changes in ESR

    measured in mm/h by kinetic flow analysis in capillaries on a photometric basis

    Measured: At baseline, after 5 and 9 days as well as 1 month afterwards

  13. Changes in CRP

    measured in serum by a routine technique

    Measured: At baseline, after 5 and 9 days as well as 1 month afterwards

  14. Changes in IL-6

    measured in serum by a routine technique (ECLIA)

    Measured: At baseline, after 5 and 9 days as well as 1 month afterwards

  15. Changes in IL-10

    measured in serum by a routine technique

    Measured: At baseline, after 5 and 9 days as well as 1 month afterwards

  16. Changes in TNF-a

    measured in serum by a routine technique (CLIA)

    Measured: At baseline, after 5 and 9 days as well as 1 month afterwards

  17. Changes in gut microbiome composition

    Shotgun metagenomics, qPCR, SCFA

    Measured: At baseline, first stool after 9 days as well as 1 month afterwards

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2023
  2. Study start1 Apr 2023
  3. Primary completion17 Aug 2023
  4. Study completion17 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective, two-arm interventional study
Masking
Single blind
Who is masked
Participant
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05821660
Sponsor's protocol ID
F-2023-014
Acronym
Fastreset
Status last verified
Sep 2025
First submitted
22 Mar 2023
Last updated
1 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Grundler F, Ducarmon QR, Holley A, Knufinke M, Strathmeyer S, Heelemann S, Geyer R, Martinez-Tellez B, MacArthur MR, Zeller G, Wilhelmi de Toledo F, Mesnage R. Health benefits of a five-day at-home modified fasting program: a randomised controlled trial. Genome Med. 2026 Jun 1;18(1):80. doi: 10.1186/s13073-026-01681-3.

    PubMed 42226305

Questions about this trial

What is this clinical trial studying?

A study testing Five-day hypocaloric and ketogenic programme in people with Healthy Nutrition and Healthy Lifestyle, run by Buchinger Wilhelmi Development & Holding GmbH at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in body weight (time frame: through study completion (11 subsequent days as well as one month afterwards)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05821660, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.

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