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Completed

NCT Number: NCT05821660

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

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

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Key information

Conditions

Healthy Nutrition Healthy Lifestyle

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Buchinger Wilhelmi Clinic

Überlingen, Baden-Wurttemberg, 88662, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Five-day hypocaloric and ketogenic programme

Other

Dietary intervention

Other names: Buchinger Wilhelmi Fastingbox

Primary outcomes

  1. Changes in body weight

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

    in kg

  2. Changes in systolic blood pressure

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

    in mmHg

  3. Changes in diastolic blood pressure

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

    in mmHg

Secondary outcomes

  1. Changes in acetoacetic acid

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

    measured by nitroprussid test in urine in mg/dL

  2. Changes in total cholesterol

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

    measured in serum by a routine technique (photometry)

  3. Changes in HDL-C

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

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

  4. Changes in LDL-C

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

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

  5. Changes in triglycerides

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

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

  6. Changes in glucose

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

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

  7. Changes in HbA1c

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

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

  8. Changes in Insulin

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

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

  9. Changes in total antioxidant capacity

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

    measured in serum by a routine technique

  10. Changes in lipidperoxidation

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

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

  11. Changes in well-being

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

    WHO-5 well-being index

  12. Changes in ESR

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

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

  13. Changes in CRP

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

    measured in serum by a routine technique

  14. Changes in IL-6

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

    measured in serum by a routine technique (ECLIA)

  15. Changes in IL-10

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

    measured in serum by a routine technique

  16. Changes in TNF-a

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

    measured in serum by a routine technique (CLIA)

  17. Changes in gut microbiome composition

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

    Shotgun metagenomics, qPCR, SCFA

Other outcomes

  1. Changes in body mass index

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

    in kg/m²

  2. Changes in abdominal circumference

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

    in cm

  3. Changes in resting heart frequency

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

    in beats/min

  4. Changes in leucocytes

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

    measured in serum by a routine technique (electronic count)

  5. Changes in erythrocytes

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

    measured in serum by a routine technique (electronic count)

  6. Changes in haemoglobin

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

    measured in serum by a routine technique (photometry)

  7. Changes in haematocrit

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

    measured in serum by a routine technique (electronic count)

  8. Changes in MCV

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

    measured in serum by a routine technique (ELISA)

  9. Changes in MCH

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

    measured in serum by a routine technique

  10. Changes in MCHC

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

    measured in serum by a routine technique

  11. Changes in thrombocytes

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

    measured in serum by a routine technique (electronic count)

  12. Changes in INR

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

    measured in serum by a routine technique (coagulometry) in sec

  13. Changes in PTT

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

    measured in serum by a routine technique (coagulometry) in sec

  14. Changes in kidney parameters

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

    blood parameters: uric acid, urea, creatinine in mg/dl

  15. Changes in uric acid

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

    measured in serum by a routine technique (enzymatic/uricase/peroxidas) in mg/dl

  16. Changes in urea

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

    measured in serum by a routine technique (GLDH) in mg/dl

  17. Changes in creatinine

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

    measured in serum by a routine technique (creatininase) in mg/dl

  18. Changes in GOT

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

    measured in serum by a routine technique (IFCC method) in U/l

  19. Changes in GPT

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

    measured in serum by a routine technique (IFCC method) in U/l

  20. Changes in GGT

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

    measured in serum by a routine technique (IFCC modified) in U/l

  21. Changes in AP

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

    measured in serum by a routine technique in U/l

  22. Changes in sodium

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

    measured in serum by a routine technique (potentiometric, ISE) in mmol/l

  23. Changes in potassium

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

    measured in serum by a routine technique (potentiometric, ISE) in mmol/l

  24. Changes in calcium

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

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

  25. Changes in magnesium

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

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

  26. Changes in continous glucose monitoring

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

    glucose level in mg/dl

  27. Changes in physical activity level

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

    questionnaires: International Physical Activity Questionnaire (IPAQ) 150min./week of exercise is considered sufficient physical activity

  28. Changes in sleep quality

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

    questionnaires: Pittsburgh Sleep Quality Index (PSQI), score ranging from 0 to 21, where lower scores denote a healthier sleep quality

  29. Changes in processed food consumption

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

    questionnaire: highly processed food consumption (sQ-HPF)

  30. Changes in physical well-being

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

    measured by visual scale (0-10)

  31. Changes in emotional well-being

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

    measured by visual scale (0-10)

  32. Changes in energy level

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

    measured by visual scale (0-10)

  33. Changes in cravings

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

    measured by visual scale (0-10)

  34. Changes in feeling bloated

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

    measured by visual scale (0-10)

  35. Changes in feeling cold

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

    measured by visual scale (0-10)

  36. Changes in tiredness

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

    measured by visual scale (0-10)

  37. Changes in muscle weakness

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

    measured by visual scale (0-10)

  38. Changes in back pain

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

    measured by visual scale (0-10)

  39. Changes in headache

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

    measured by visual scale (0-10)

  40. Changes in hunger

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

    measured by visual scale (0-10)

  41. Changes in anxiety

    Time frame: through study completion (11 subsequent days as well as one month afterwards9

    measured by visual scale (0-10)

  42. Changes in digestive problems

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

    measured by visual scale (0-10)

  43. Changes in optimism

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

    measured by visual scale (0-4)

  44. Changes in relaxation

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

    measured by visual scale (0-4)

  45. Changes in clear thinking

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

    measured by visual scale (0-4)

  46. Changes in confidence

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

    measured by visual scale (0-4)

  47. Changes in happiness

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

    measured by visual scale (0-4)

  48. Changes in physical activity

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

    measured by visual scale (0-10) and absolut numbers

  49. Ethnicity

    Time frame: baseline

    Caucasian, Hispanic, African American, Asian, others

  50. Smoking

    Time frame: baseline

    status: never, former, current, flatmate

  51. Alcohol consumption

    Time frame: baseline, after 5 and 9 days as well as 1 month afterwards

    number of glasses: wine, beer, spirits

  52. Changes in stress level

    Time frame: baseline, after 5 and 9 days as well as 1 month afterwards

    measured by visual scale (0-10)

  53. Changes in energy level

    Time frame: baseline, after 5 and 9 days as well as 1 month afterwards

    measured by visual scale (0-10)

  54. Changes in pain level

    Time frame: baseline, after 5 and 9 days as well as 1 month afterwards

    measured by visual scale (0-10)

Sponsors and collaborators

Lead sponsor

Buchinger Wilhelmi Development & Holding GmbH

Other

Collaborators

  • King's College London
  • MVZ Labor Ravensburg GbR
  • Synlab Málaga

Registry information

Official study title

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

Acronym: Fastreset

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 20, 2023
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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