FastingNCT05031598
Long-term Fasting: Multi-system Adaptations in Humans
A study testing Long-term fasting according to the Buchinger Wilhelmi fasting program in people with Fasting, run by Buchinger Wilhelmi Development & Holding GmbH at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Fasting
- What is being tested?
- Long-term fasting according to the Buchinger Wilhelmi fasting program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteGermany
- Study dates
- 10 Sep 2021to 31 Dec 2022
- 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 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI between 22 - 35 kg/m2
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Fasting
- Being tested
- Long-term fasting according to the Buchinger Wilhelmi fasting program
- Keywords
- long-term fasting, Buchinger Wilhelmi program, magnetic resonance imaging (MRI), magnetic resonance spectroscopy (MRS), HDL efflux capacity, fatty acid profile in erythrocyte membrane, gut microbiota, metabolomics, hydrogen sulfide and transsulfuration pathway
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long-term fasting according to the Buchinger Wilhelmi fasting programOther
the participants will undergo a fasting program that includes the daily intake of 250 kcal under medical supervision
| Study group | Role | What they receive |
|---|---|---|
| Long-term fasting | Experimental | The participants will undergo 6-12 fasting days according to the Buchinger Wilhelmi fasting program Receives: Other: Long-term fasting according to the Buchinger Wilhelmi fasting program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in whole body composition
Fat mass, lean mass, water content measured by magnetic resonance imaging
Measured: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in the composition of the heart
Fat mass, lean mass, water content measured by magnetic resonance imaging
Measured: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in the composition of the liver
Fat mass, lean mass, water content measured by magnetic resonance imaging
Measured: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in the composition of the kidney
Fat mass, lean mass, water content measured by magnetic resonance imaging
Measured: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in the composition of the spleen
Fat mass, lean mass, water content measured by magnetic resonance imaging
Measured: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in the composition of the quadriceps
Fat mass, lean mass, water content measured by magnetic resonance imaging
Measured: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in the composition of the adipose tissue
Fat mass, lean mass, water content measured by magnetic resonance imaging
Measured: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in HDL cholesterol efflux capacity
measured in serum by a standardized used radioisotopic technique
Measured: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in serum cholesterol loading capacity
measured in serum using radioactive cholesterol loaded macrophages
Measured: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in HS-Omega-3 Index
Determination of fatty acid (C 14:0; 16:0; 18:0; 20:0; 22:0; 24:0; 16:1 n-7; 18:1 n-9; 20:1 n-9; 24:1 n-9; 18:2 n-6; 18: 3 n-6; 20: 3 n-6; 22:2 n-6; 20:4 n-6; 22:4 n-6; 22:5 n-6; 18: 3 n-3; 20:5 n-3; 22:5 n-3; 22:6 n-3; 16:1 n-7t; 18:1 n-9t; 18:2 n-6tt; 18:2 n-6ct; 18:2 n-6tc) in erythrocyte membranes with highly standardized analytical procedure
Measured: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in faecal microbiota composition and function (carbohydrate metabolism)
Shotgun metagenomics, 5Gb of DNA sequencing data.
Measured: Baseline and changes after an average of 10 (+/-3) fasting days
Changes in metabolome
using an untargeted metabolomics approach to investigate changes in the metabolome, with a focus on the polyamine biosynthetic pathway at the cellular level in PBMCs and compare them with changes in the circulating plasma/serum metabolome
Measured: Baseline and changes after 3 fasting days, the end of fasting as well as one and four months afterwards
Changes in hydrogen sulfide production capacity
measured in serum and urine using the lead acetate assay
Measured: Baseline and changes at the end of fasting as well as one and four months afterwards
Secondary outcomes (39)
Changes in brain morphometry
measured by magnetic resonance imaging
Measured: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in cardiac mass
measured by magnetic resonance imaging
Measured: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in lower limbs (quadriceps, hamstrings, calves)
measured by magnetic resonance imaging
Measured: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in lumbosacral muscle mass
measured by magnetic resonance imaging
Measured: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in systolic cardiac function
global and regional function (right and left ejection fraction, right and left end-diastolic and end-systolic volumes, peak regional strains (circumferential, longitudinal strain) measured with magnetic resonance imaging
Measured: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in diastolic cardiac function
global and regional diastolic function (peak filling rate, torsion rate, diastolic strain rate) measured with magnetic resonance imaging
Measured: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in apparent diffusion coefficient (ADC)
measured with magnetic impedance imaging
Measured: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in fiber strain (Eff)
measured with magnetic impedance imaging
Measured: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in fractional anisotropy (FA)
measured with magnetic impedance imaging
Measured: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in helix angle (HA)
measured with magnetic impedance imaging
Measured: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in mean diffusivity (MD)
measured with magnetic impedance imaging
Measured: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in cardiovascular fitness
using the maximal oxygen consumption (VO2max)
Measured: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in muscle metabolism and mitochondrial oxidative capacity: TauPCr(s)
during ergometric effort in MRI at the level of the sural muscle (31P spectroscopy)
Measured: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in muscle metabolism and mitochondrial oxidative capacity: PCr hydrolysis (%)
during ergometric effort in MRI at the level of the sural muscle (31P spectroscopy)
Measured: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in muscle metabolism and mitochondrial oxidative capacity: PCr concentration
during ergometric effort in MRI at the level of the sural muscle (31P spectroscopy)
Measured: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in muscle metabolism and mitochondrial oxidative capacity: Pi concentration
during ergometric effort in MRI at the level of the sural muscle (31P spectroscopy)
Measured: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in muscle metabolism and mitochondrial oxidative capacity: ATP concentration
during ergometric effort in MRI at the level of the sural muscle (31P spectroscopy)
Measured: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in muscle metabolism and mitochondrial oxidative capacity: pH at rest and post exercise in mM
during ergometric effort in MRI at the level of the sural muscle (31P spectroscopy)
Measured: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in muscle metabolism and mitochondrial oxidative capacity: T1 of metabolites at rest
during ergometric effort in MRI at the level of the sural muscle (31P spectroscopy)
Measured: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in muscle metabolism and mitochondrial oxidative capacity: PCr consumption
during ergometric effort in MRI at the level of the sural muscle (31P spectroscopy)
Measured: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in multiparametric muscle quantification: T2
measured with quantitative magnetic impedance imaging
Measured: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in multiparametric muscle quantification: T2 * relaxation time
measured with quantitative magnetic impedance imaging
Measured: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in multiparametric muscle quantification: susceptibility (chi)
measured with quantitative magnetic impedance imaging
Measured: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in multiparametric muscle quantification: fat fraction (PDFF)
measured with quantitative magnetic impedance imaging
Measured: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in quadricipital maximum voluntary contraction
measured with magnetic impedance imaging
Measured: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in DNA methylation
biomarker of biological aging using erythrocytes
Measured: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in serum amyloid A levels
determined in serum
Measured: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in paraoxonase (PON-1) activity
determined in serum
Measured: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in lipoprotein transfer enzymes
CETP activity, determined as U/ml using a commercially available assay
Measured: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in GlycA
determined in serum
Measured: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in proprotein convertase subtilisin/kexin type 9 (PCSK9)
determined in serum by ELISA
Measured: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in chylomicrons
determined in serum
Measured: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in oxidized phospholipids
determined in serum
Measured: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in enzymes
immunoblotting of relevantly altered enzymes in PBMCs
Measured: Baseline and changes after 3 fasting days, the end of fasting as well as one and four months afterwards
Changes in persulfidation
persulfidation in serum and urine
Measured: Baseline, and changes after 3 fasting days, at the end of fasting as well as one and four months afterwards
Changes in sulfur compounds
amino acids (using a targeted approach), thiosulfate (measured using the monobromobimane method using HPLC and LC-MS/MS), cysteine and cystine (use the S-sulfocysteine (SSC) method which is a HPLC-based method using automated precolumn derivatization with OPA and UV detection at 338 nm) in serum and urine
Measured: Baseline and changes after 3 fasting days, at the end of fasting as well as one and four months afterwards
Changes in thiosulfate levels
measured using the monobromobimane method using HPLC and LC-MS/MS
Measured: Baseline and changes after 3 fasting days, at the end of fasting as well as one and four months afterwards
Changes in cysteine and cystine levels
using the S-sulfocysteine (SSC) method which is a HPLC-based method using automated precolumn derivatization with OPA and UV detection at 338 nm in serum and urine
Measured: Baseline and changes after 3 fasting days, at the end of fasting as well as one and four months afterwards
Changes in amino acids
using a targeted approach in serum and urine
Measured: Baseline and changes after 3 fasting days, at the end of fasting as well as one and four months afterwards
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start10 Sep 2021
- Primary completion30 Aug 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FastingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single-arm interventional study
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Buchinger Wilhelmi Development & Holding GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Claude Bernard University, University of Milan, Omegametrix GmbH, King's College London, MVZ Humangenetik Ulm, University of Graz, Leiden University Medical Center, MVZ Labor Ravensburg, ETH Zurich
- Responsible party
- Principal investigator, Françoise Wilhelmi de Toledo, Buchinger Wilhelmi Development & Holding GmbH
- Investigators
- Françoise Wilhelmi de Toledo, Dr, Principal investigator, Buchinger Wilhelmi Development & Holding GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05031598
- Sponsor's protocol ID
- F-2021-075
- Status last verified
- Feb 2023
- First submitted
- 11 Aug 2021
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Grundler F, Palumbo M, Adorni MP, Zimetti F, Papotti B, Plonne D, Holley A, Mesnage R, Ruscica M, Wilhelmi de Toledo F. HDL cholesterol efflux capacity and cholesterol loading capacity in long-term fasting: Evidence from a prospective, single-arm interventional study in healthy individuals. Atherosclerosis. 2024 Oct;397:118548. doi: 10.1016/j.atherosclerosis.2024.118548. Epub 2024 Aug 6.
PubMed 39180960Grundler F, Viallon M, Mesnage R, Ruscica M, von Schacky C, Madeo F, Hofer SJ, Mitchell SJ, Croisille P, Wilhelmi de Toledo F. Long-term fasting: Multi-system adaptations in humans (GENESIS) study-A single-arm interventional trial. Front Nutr. 2022 Nov 17;9:951000. doi: 10.3389/fnut.2022.951000. eCollection 2022.
PubMed 36466423
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Fasting: Multi-system Adaptations in Humans
- ClinicalTrials.gov ID
- NCT05031598
- Acronym / sponsor ID
- F-2021-075
- Conditions
- Fasting
- Keywords
- long-term fasting, Buchinger Wilhelmi program, magnetic resonance imaging (MRI), magnetic resonance spectroscopy (MRS), HDL efflux capacity, fatty acid profile in erythrocyte membrane, gut microbiota, metabolomics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Buchinger Wilhelmi Development & Holding GmbHUniversity, hospital or other
- Collaborators
- Claude Bernard University, University of Milan, Omegametrix GmbH, King's College London, MVZ Humangenetik Ulm, University of Graz, Leiden University Medical Center, MVZ Labor Ravensburg, ETH Zurich
- Study start
- 10 Sep 2021 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 2 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single-arm interventional study
| Arm | Type | Receives |
|---|---|---|
| Long-term fasting | Experimental | Other: Long-term fasting according to the Buchinger Wilhelmi fasting programThe participants will undergo 6-12 fasting days according to the Buchinger Wilhelmi fasting program |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- BMI between 22 - 35 kg/m2
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Long-term fasting according to the Buchinger Wilhelmi fasting programthe participants will undergo a fasting program that includes the daily intake of 250 kcal under medical supervision | Other | Long-term fasting |
Primary outcome
Changes in whole body composition
Time frame: Baseline and changes at the end of fasting as well as one and four months afterwards
Fat mass, lean mass, water content measured by magnetic resonance imaging
Changes in the composition of the heart
Time frame: Baseline and changes at the end of fasting as well as one and four months afterwards
Fat mass, lean mass, water content measured by magnetic resonance imaging
Changes in the composition of the liver
Time frame: Baseline and changes at the end of fasting as well as one and four months afterwards
Fat mass, lean mass, water content measured by magnetic resonance imaging
Changes in the composition of the kidney
Time frame: Baseline and changes at the end of fasting as well as one and four months afterwards
Fat mass, lean mass, water content measured by magnetic resonance imaging
Changes in the composition of the spleen
Time frame: Baseline and changes at the end of fasting as well as one and four months afterwards
Fat mass, lean mass, water content measured by magnetic resonance imaging
Changes in the composition of the quadriceps
Time frame: Baseline and changes at the end of fasting as well as one and four months afterwards
Fat mass, lean mass, water content measured by magnetic resonance imaging
Changes in the composition of the adipose tissue
Time frame: Baseline and changes at the end of fasting as well as one and four months afterwards
Fat mass, lean mass, water content measured by magnetic resonance imaging
Changes in HDL cholesterol efflux capacity
Time frame: Baseline and changes at the end of fasting as well as one and four months afterwards
measured in serum by a standardized used radioisotopic technique
Changes in serum cholesterol loading capacity
Time frame: Baseline and changes at the end of fasting as well as one and four months afterwards
measured in serum using radioactive cholesterol loaded macrophages
Changes in HS-Omega-3 Index
Time frame: Baseline and changes at the end of fasting as well as one and four months afterwards
Determination of fatty acid (C 14:0; 16:0; 18:0; 20:0; 22:0; 24:0; 16:1 n-7; 18:1 n-9; 20:1 n-9; 24:1 n-9; 18:2 n-6; 18: 3 n-6; 20: 3 n-6; 22:2 n-6; 20:4 n-6; 22:4 n-6; 22:5 n-6; 18: 3 n-3; 20:5 n-3; 22:5 n-3; 22:6 n-3; 16:1 n-7t; 18:1 n-9t; 18:2 n-6tt; 18:2 n-6ct; 18:2 n-6tc) in erythrocyte membranes with highly standardized analytical procedure
Changes in faecal microbiota composition and function (carbohydrate metabolism)
Time frame: Baseline and changes after an average of 10 (+/-3) fasting days
Shotgun metagenomics, 5Gb of DNA sequencing data.
Changes in metabolome
Time frame: Baseline and changes after 3 fasting days, the end of fasting as well as one and four months afterwards
using an untargeted metabolomics approach to investigate changes in the metabolome, with a focus on the polyamine biosynthetic pathway at the cellular level in PBMCs and compare them with changes in the circulating plasma/serum metabolome
Changes in hydrogen sulfide production capacity
Time frame: Baseline and changes at the end of fasting as well as one and four months afterwards
measured in serum and urine using the lead acetate assay
39 secondary outcomes
Changes in brain morphometry
Time frame: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in cardiac mass
Time frame: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in lower limbs (quadriceps, hamstrings, calves)
Time frame: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in lumbosacral muscle mass
Time frame: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in systolic cardiac function
Time frame: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in diastolic cardiac function
Time frame: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in apparent diffusion coefficient (ADC)
Time frame: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in fiber strain (Eff)
Time frame: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in fractional anisotropy (FA)
Time frame: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in helix angle (HA)
Time frame: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in mean diffusivity (MD)
Time frame: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in cardiovascular fitness
Time frame: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in muscle metabolism and mitochondrial oxidative capacity: TauPCr(s)
Time frame: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in muscle metabolism and mitochondrial oxidative capacity: PCr hydrolysis (%)
Time frame: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in muscle metabolism and mitochondrial oxidative capacity: PCr concentration
Time frame: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in muscle metabolism and mitochondrial oxidative capacity: Pi concentration
Time frame: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in muscle metabolism and mitochondrial oxidative capacity: ATP concentration
Time frame: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in muscle metabolism and mitochondrial oxidative capacity: pH at rest and post exercise in mM
Time frame: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in muscle metabolism and mitochondrial oxidative capacity: T1 of metabolites at rest
Time frame: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in muscle metabolism and mitochondrial oxidative capacity: PCr consumption
Time frame: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in multiparametric muscle quantification: T2
Time frame: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in multiparametric muscle quantification: T2 * relaxation time
Time frame: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in multiparametric muscle quantification: susceptibility (chi)
Time frame: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in multiparametric muscle quantification: fat fraction (PDFF)
Time frame: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in quadricipital maximum voluntary contraction
Time frame: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in DNA methylation
Time frame: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in serum amyloid A levels
Time frame: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in paraoxonase (PON-1) activity
Time frame: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in lipoprotein transfer enzymes
Time frame: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in GlycA
Time frame: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in proprotein convertase subtilisin/kexin type 9 (PCSK9)
Time frame: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in chylomicrons
Time frame: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in oxidized phospholipids
Time frame: Baseline and changes at the end of fasting as well as one and four months afterwards
Changes in enzymes
Time frame: Baseline and changes after 3 fasting days, the end of fasting as well as one and four months afterwards
Changes in persulfidation
Time frame: Baseline, and changes after 3 fasting days, at the end of fasting as well as one and four months afterwards
Changes in sulfur compounds
Time frame: Baseline and changes after 3 fasting days, at the end of fasting as well as one and four months afterwards
Changes in thiosulfate levels
Time frame: Baseline and changes after 3 fasting days, at the end of fasting as well as one and four months afterwards
Changes in cysteine and cystine levels
Time frame: Baseline and changes after 3 fasting days, at the end of fasting as well as one and four months afterwards
Changes in amino acids
Time frame: Baseline and changes after 3 fasting days, at the end of fasting as well as one and four months afterwards
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Derived from this study: PubMed 39180960Grundler F, Palumbo M, Adorni MP, Zimetti F, Papotti B, Plonne D, Holley A, Mesnage R, Ruscica M, Wilhelmi de Toledo F. HDL cholesterol efflux capacity and cholesterol loading capacity in long-term fasting: Evidence from a prospective, single-arm interventional study in healthy individuals. Atherosclerosis. 2024 Oct;397:118548. doi: 10.1016/j.atherosclerosis.2024.118548. Epub 2024 Aug 6.
- Derived from this study: PubMed 36466423Grundler F, Viallon M, Mesnage R, Ruscica M, von Schacky C, Madeo F, Hofer SJ, Mitchell SJ, Croisille P, Wilhelmi de Toledo F. Long-term fasting: Multi-system adaptations in humans (GENESIS) study-A single-arm interventional trial. Front Nutr. 2022 Nov 17;9:951000. doi: 10.3389/fnut.2022.951000. eCollection 2022.
- Individual participant dataSharing planned: Undecided
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A Bioequivalence and Safety Study of AJU-B718 and B718R in Healthy Adult Volunteers Under Fasting Conditions
Peripheral Arterial Disease
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A Bioequivalence and Safety Study of AJU-C719 and C719R in Healthy Adult Volunteers
Hypertension
Active, not recruitingPhase 4
Comparison of Two Timings of Levothyroxine Intake in Hypothyroid Patients: A Cross-over Randomized Control Trial
Hypothyroidism Primary
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Françoise Wilhelmi de Toledo, Dr principal investigator
Buchinger Wilhelmi Development & Holding GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Long-term fasting according to the Buchinger Wilhelmi fasting program in people with Fasting, 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 1 inclusion and 8 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 8 Feb 2023. 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 whole body composition (time frame: Baseline and changes at the end of fasting as well as one and four months afterwards). The study lists 13 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 NCT05031598, which also lists 2 linked publications.
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 8 Feb 2023.