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Long-term Fasting: Multi-system Adaptations in Humans

B

Buchinger Wilhelmi Development

Status

Completed

Conditions

Fasting

Treatments

Other: Long-term fasting according to the Buchinger Wilhelmi fasting program

Study type

Interventional

Funder types

Other

Identifiers

NCT05031598
F-2021-075

Details and patient eligibility

About

The aim of this trial is to investigate the effects of long-term fasting on size, mass, composition and function of metabolic active tissues in several organs that reexpand possibly rejuvenated after 1-4 months. Additionally, the lipid metabolism is investigated in depth.

Full description

Fasting displays numerous positive effects on metabolism, health and aging. Surprisingly, few considerations are given to long-term fasting periods.

The metabolic switch from food-derived glucose to adipose tissue-derived fatty acids and ketones as primary cellular fuel is the key to fasting metabolism. Fasting has been shown to improve cardiovascular risk factors and gut microbiota in humans. It provokes profound changes in lipid metabolism. However, many questions are still open concerning the mobilization, exchange, and function of lipids during long-term fasting. Furthermore, recent results show the ability of periodic restrictive nutritional strategies to trigger organ regeneration. This promising regenerative power has not been investigated comprehensively in humans. In addition, the knowledge about the role of human faecal microbiota in health and disease is increasing. Only little is known about its composition and function during fasting. We found indications that the gut microbiome could influence energy metabolism and consequently could influence the dynamic of the metabolic switch.

Long-term fasting under medical supervision according to the Buchinger Wilhelmi fasting program has been demonstrated to be safe and well-tolerated.

The current project investigates the effects of a 9±3 days fasting period by a multi-systemic approach focusing on lipid metabolism and the gut microbiome in 100 subjects. Additionally, the body composition in combination with muscle performance will be analyzed in-depth in a subgroup of 32 subjects.

Enrollment

62 patients

Sex

All

Ages

20 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • BMI between 22 - 35 kg/m2

Exclusion criteria

  • intake of medication (cardiovascular diseases, lipid and glucose metabolism)
  • chronic manifest psychical and psychiatric diseases
  • participation in another study
  • pregnancy or breastfeeding
  • in the MRI/MRS sub-study, any MRI contraindication (claustrophobia, pacemakers, MR-incompatible prosthetic valves, metallic implants, foreign metallic body)
  • active uncontrolled gastrointestinal disorders including ulcerative colitis, Crohn's disease, indeterminate colitis, severe irritable bowel syndrome, persistent infectious gastroenteritis, persistent or chronic diarrhea of unknown etiology, recurrent Clostridium difficile infection
  • major surgery of the GI tract, in the past five years. Any major bowel resection at any time
  • intake of antibiotics in the last 2 months

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

62 participants in 1 patient group

Long-term fasting
Experimental group
Description:
The participants will undergo 6-12 fasting days according to the Buchinger Wilhelmi fasting program
Treatment:
Other: Long-term fasting according to the Buchinger Wilhelmi fasting program

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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