Long-term Fasting: Multi-system Adaptations in Humans

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

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-10

Study Completion Date

2022-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Fasting

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

single-arm interventional study

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Long-term fasting

The participants will undergo 6-12 fasting days according to the Buchinger Wilhelmi fasting program

Group Type EXPERIMENTAL

Long-term fasting according to the Buchinger Wilhelmi fasting program

Intervention Type OTHER

the participants will undergo a fasting program that includes the daily intake of 250 kcal under medical supervision

Interventions

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Long-term fasting according to the Buchinger Wilhelmi fasting program

the participants will undergo a fasting program that includes the daily intake of 250 kcal under medical supervision

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes