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Long-term Fasting: Multi-system Adaptations in Humans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05031598
Recruitment Status : Recruiting
First Posted : September 2, 2021
Last Update Posted : November 11, 2021
Sponsor:
Collaborators:
Buchinger Wilhelmi Clinic
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
Information provided by (Responsible Party):
Françoise Wilhelmi de Toledo, Buchinger Wilhelmi Development & Holding GmbH

Brief 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.

Condition or disease Intervention/treatment Phase
Fasting Other: Long-term fasting according to the Buchinger Wilhelmi fasting program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: single-arm interventional study
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Long-term Fasting: Multi-system Adaptations in Humans
Actual Study Start Date : September 10, 2021
Estimated Primary Completion Date : August 30, 2022
Estimated Study Completion Date : October 31, 2022

Arm Intervention/treatment
Experimental: Long-term fasting
The participants will undergo 6-12 fasting days according to the Buchinger Wilhelmi fasting program
Other: 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




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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.

  12. 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

  13. 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


Secondary Outcome Measures :
  1. Changes in brain morphometry [ Time Frame: Baseline and changes at the end of fasting as well as one and four months afterwards ]
    measured by magnetic resonance imaging

  2. Changes in cardiac mass [ Time Frame: Baseline and changes at the end of fasting as well as one and four months afterwards ]
    measured by magnetic resonance imaging

  3. 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 ]
    measured by magnetic resonance imaging

  4. Changes in lumbosacral muscle mass [ Time Frame: Baseline and changes at the end of fasting as well as one and four months afterwards ]
    measured by magnetic resonance imaging

  5. Changes in systolic cardiac function [ Time Frame: Baseline and changes at the end of fasting as well as one and four months afterwards ]
    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

  6. Changes in diastolic cardiac function [ Time Frame: Baseline and changes at the end of fasting as well as one and four months afterwards ]
    global and regional diastolic function (peak filling rate, torsion rate, diastolic strain rate) measured with magnetic resonance imaging

  7. Changes in apparent diffusion coefficient (ADC) [ Time Frame: Baseline and changes at the end of fasting as well as one and four months afterwards ]
    measured with magnetic impedance imaging

  8. Changes in fiber strain (Eff) [ Time Frame: Baseline and changes at the end of fasting as well as one and four months afterwards ]
    measured with magnetic impedance imaging

  9. Changes in fractional anisotropy (FA) [ Time Frame: Baseline and changes at the end of fasting as well as one and four months afterwards ]
    measured with magnetic impedance imaging

  10. Changes in helix angle (HA) [ Time Frame: Baseline and changes at the end of fasting as well as one and four months afterwards ]
    measured with magnetic impedance imaging

  11. Changes in mean diffusivity (MD) [ Time Frame: Baseline and changes at the end of fasting as well as one and four months afterwards ]
    measured with magnetic impedance imaging

  12. Changes in cardiovascular fitness [ Time Frame: Baseline and changes at the end of fasting as well as one and four months afterwards ]
    using the maximal oxygen consumption (VO2max)

  13. 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 ]
    during ergometric effort in MRI at the level of the sural muscle (31P spectroscopy)

  14. 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 ]
    during ergometric effort in MRI at the level of the sural muscle (31P spectroscopy)

  15. 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 ]
    during ergometric effort in MRI at the level of the sural muscle (31P spectroscopy)

  16. 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 ]
    during ergometric effort in MRI at the level of the sural muscle (31P spectroscopy)

  17. 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 ]
    during ergometric effort in MRI at the level of the sural muscle (31P spectroscopy)

  18. 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 ]
    during ergometric effort in MRI at the level of the sural muscle (31P spectroscopy)

  19. 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 ]
    during ergometric effort in MRI at the level of the sural muscle (31P spectroscopy)

  20. 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 ]
    during ergometric effort in MRI at the level of the sural muscle (31P spectroscopy)

  21. Changes in multiparametric muscle quantification: T2 [ Time Frame: Baseline and changes at the end of fasting as well as one and four months afterwards ]
    measured with quantitative magnetic impedance imaging

  22. 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 ]
    measured with quantitative magnetic impedance imaging

  23. 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 ]
    measured with quantitative magnetic impedance imaging

  24. 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 ]
    measured with quantitative magnetic impedance imaging

  25. Changes in quadricipital maximum voluntary contraction [ Time Frame: Baseline and changes at the end of fasting as well as one and four months afterwards ]
    measured with magnetic impedance imaging

  26. Changes in DNA methylation [ Time Frame: Baseline and changes at the end of fasting as well as one and four months afterwards ]
    biomarker of biological aging using erythrocytes

  27. Changes in serum amyloid A levels [ Time Frame: Baseline and changes at the end of fasting as well as one and four months afterwards ]
    determined in serum

  28. Changes in paraoxonase (PON-1) activity [ Time Frame: Baseline and changes at the end of fasting as well as one and four months afterwards ]
    determined in serum

  29. Changes in lipoprotein transfer enzymes [ Time Frame: Baseline and changes at the end of fasting as well as one and four months afterwards ]
    CETP activity, determined as U/ml using a commercially available assay

  30. Changes in GlycA [ Time Frame: Baseline and changes at the end of fasting as well as one and four months afterwards ]
    determined in serum

  31. 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 ]
    determined in serum by ELISA

  32. Changes in chylomicrons [ Time Frame: Baseline and changes at the end of fasting as well as one and four months afterwards ]
    determined in serum

  33. Changes in oxidized phospholipids [ Time Frame: Baseline and changes at the end of fasting as well as one and four months afterwards ]
    determined in serum

  34. Changes in enzymes [ Time Frame: Baseline and changes after 3 fasting days, the end of fasting as well as one and four months afterwards ]
    immunoblotting of relevantly altered enzymes in PBMCs

  35. 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 ]
    persulfidation in serum and urine

  36. 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 ]
    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

  37. 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 ]
    measured using the monobromobimane method using HPLC and LC-MS/MS

  38. 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 ]
    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

  39. 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 ]
    using a targeted approach in serum and urine


Other Outcome Measures:
  1. Changes in body weight [ Time Frame: Baseline, daily during fasting and food reintroduction as well as one and four months afterwards ]
    in kg

  2. Changes in body mass index [ Time Frame: Baseline, daily during fasting and food reintroduction as well as one and four months afterwards ]
    in kg/m²

  3. Changes in abdominal circumference [ Time Frame: Baseline and changes at the end of fasting as well as one and four months afterwards ]
    in cm

  4. Changes in resting systolic blood pressure [ Time Frame: Baseline, daily during fasting and food reintroduction as well as one and four months afterwards ]
    in mmHg

  5. Changes in resting diastolic blood pressure [ Time Frame: Baseline, daily during fasting and food reintroduction as well as one and four months afterwards ]
    in mmHg

  6. Changes in resting heart frequency [ Time Frame: Baseline, daily during fasting and food reintroduction as well as one and four months afterwards ]
    in beats/min

  7. Changes in bio-electrical multifrequency impedance analysis [ Time Frame: Baseline and changes at the end of fasting as well as one and four months afterwards ]
    Global and segmental body composition (water, fat and lean mass), liquid distribution (total, extracellular and intracellular water), metabolic indexes (metabolic activity index (MAI), protein content (total and active cell mass fraction) as determined by bioimpedance analysis

  8. Changes in liver stiffness [ Time Frame: Baseline, during and after fasting ]
    measured by FibroScan

  9. Changes in physical activity [ Time Frame: Before, daily during fasting as well as one and four months afterwards ]
    intensity, duration, frequency measured by triaxial actigraphy

  10. Changes in circadian rhythm and sleep [ Time Frame: Before, daily during fasting as well as one and four months afterwards ]
    measured by triaxial actigraphy

  11. Changes in mental well-being [ Time Frame: Baseline and at the end of fasting as well as one and four months afterwards ]
    questionnaires: Warwick-Edinburgh Mental Well-Being Scale

  12. Changes in global health [ Time Frame: Baseline and at the end of fasting as well as one and four months afterwards ]
    questionnaires: PROMIS Scale

  13. Changes in physical activity [ Time Frame: Baseline and at the end of fasting as well as one and four months afterwards ]
    questionnaires: Godin Leisure-Time Exercise Questionnaire

  14. Changes in sleep quality [ Time Frame: Baseline and at the end of fasting as well as one and four months afterwards ]
    questionnaires: Pittsburgh Sleep Quality Index

  15. Changes in ketonuria [ Time Frame: during the fasting period and food reintroduction ]
    Ketone bodies in urine measured by urine dip sticks

  16. Changes in ketonemia [ Time Frame: during the fasting period and food reintroduction ]
    Ketone bodies in capillary blood

  17. Changes in glycemia [ Time Frame: during the fasting period and food reintroduction ]
    Glucose in capillary blood

  18. Changes in dietary behaviour [ Time Frame: Baseline and after fasting as well as one and four months afterwards ]
    questionnaire: short healthy eating index survey

  19. Changes in smoking behaviour [ Time Frame: Baseline and after fasting as well as one and four months afterwards ]
    questionnaire

  20. Changes in alcohol consumption [ Time Frame: Baseline and after fasting as well as one and four months afterwards ]
    questionnaire

  21. Changes in physical activity [ Time Frame: Baseline and after fasting as well as one and four months afterwards ]
    in hours/week

  22. Changes in energy level [ Time Frame: Baseline, daily during fasting and food reintroduction as well as one and four months afterwards ]
    measured by visual scale (0-10)

  23. Changes in emotional well-being [ Time Frame: Baseline, daily during fasting and food reintroduction as well as one and four months afterwards ]
    measured by visual scale (0-10)

  24. Changes in physical well-being [ Time Frame: Baseline, daily during fasting and food reintroduction as well as one and four months afterwards ]
    measured by visual scale (0-10)

  25. Changes in symptoms: fatigue [ Time Frame: Baseline, daily during fasting and food reintroduction as well as one and four months afterwards ]
    measured by visual scale (0-10)

  26. Changes in symptoms: muscle weakness [ Time Frame: Baseline, daily during fasting and food reintroduction as well as one and four months afterwards ]
    measured by visual scale (0-10)

  27. Changes in symptoms: back pain [ Time Frame: Baseline, daily during fasting and food reintroduction as well as one and four months afterwards ]
    measured by visual scale (0-10)

  28. Changes in symptoms: hunger [ Time Frame: Baseline, daily during fasting and food reintroduction as well as one and four months afterwards ]
    measured by visual scale (0-10)

  29. Changes in symptoms: anxiety [ Time Frame: Baseline, daily during fasting and food reintroduction as well as one and four months afterwards ]
    measured by visual scale (0-10)

  30. Changes in symptoms: headache [ Time Frame: Baseline, daily during fasting and food reintroduction as well as one and four months afterwards ]
    measured by visual scale (0-10)

  31. Changes in symptoms: sleep disturbances [ Time Frame: Baseline, daily during fasting and food reintroduction as well as one and four months afterwards ]
    measured by visual scale (0-10)

  32. Adverse events [ Time Frame: through study completion, an average of 4.5 months ]
    Documentation of side effects

  33. Changes in blood count [ Time Frame: Baseline and at the end of fasting as well as one and four months afterwards ]
    blood parameters: leucocytes, erythrocytes, haemoglobin, haematocrit, MCV, MCH, MCHC, thrombocytes, bilirubin

  34. Changes in differential blood count [ Time Frame: Baseline and at the end of fasting as well as one and four months afterwards ]
    blood parameters: basophiles, neutrophils, eosinophiles, monocytes, reticulocytes

  35. Changes in coagulation [ Time Frame: Baseline and at the end of fasting as well as one and four months afterwards ]
    blood parameters: INR, PTT in sec

  36. Changes in liver enzymes [ Time Frame: Baseline and at the end of fasting as well as one and four months afterwards ]
    blood parameters: GOT, GPT, GGT, AP in U/l

  37. Changes in kidney parameters [ Time Frame: Baseline and at the end of fasting as well as one and four months afterwards ]
    blood parameters: uric acid, urea, creatinine in mg/dl

  38. Changes in inflammatory parameters [ Time Frame: Baseline and at the end of fasting as well as one and four months afterwards ]
    blood parameters: hs-CRP, ESR in mm/h, inflammasome, cortisol in µg/dl

  39. Changes in glucose metabolism [ Time Frame: Baseline and at the end of fasting as well as one and four months afterwards ]
    blood parameters: glucose in mmol/l, HbA1c in %, insulin in mU/l

  40. Changes in lipid parameters [ Time Frame: Baseline and at the end of fasting as well as one and four months afterwards ]
    blood parameters: total cholesterol, HDL-C, LDL-C, triglycerides in mmol/l

  41. Changes in electrolytes [ Time Frame: Baseline and at the end of fasting as well as one and four months afterwards ]
    blood parameters: sodium, potassium, calcium, magnesium in mmol/l

  42. Changes in the immune response to fasting [ Time Frame: Baseline, after 3 fasting days, and at the end of fasting as well as one and four months afterwards ]
    using single cell nucleus sequencing

  43. Changes in cell populations (natural killer and T cells) [ Time Frame: Baseline, after 3 fasting days, and at the end of fasting as well as one and four months afterwards ]
    using single cell nucleus sequencing

  44. Changes in lipoprotein subclasses [ Time Frame: Baseline and changes at the end of fasting as well as one and four months afterwards ]
    determined in serum by high-density ultracentrifugation reflecting cholesterol and triglyceride composition

  45. Changes in apolipoproteins [ Time Frame: Baseline and changes at the end of fasting as well as one and four months afterwards ]
    ApoA-I and ApoB determined in serum

  46. Changes in lipoprotein(a) [ Time Frame: Baseline and changes at the end of fasting as well as one and four months afterwards ]
    determined in serum

  47. Changes in methylation based clocks [ Time Frame: Baseline and changes at the end of fasting as well as one and four months afterwards ]
    biomarker of biological aging using PBMCs

  48. Sociodemographic Measurements [ Time Frame: Baseline ]
    Age, gender, language, complete family history, current and previous illness and co-morbidities, and current medications

  49. Changes in nitrogen balance [ Time Frame: Baseline, daily during fasting as well as food reintroduction ]
    nitrogen in 24-hours-urine



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05031598


Contacts
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Contact: Buchinger Wilhelmi clinic 0049 7551 8070 forschung@buchinger-wilhelmi.com

Locations
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Germany
Buchinger Wilhelmi clinic Recruiting
Überlingen, Germany, 88662
Contact: Françoise Wilhelmi de Toledo, Dr         
Sponsors and Collaborators
Buchinger Wilhelmi Development & Holding GmbH
Buchinger Wilhelmi Clinic
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
Investigators
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Principal Investigator: Françoise Wilhelmi de Toledo, Dr Buchinger Wilhelmi Clinic
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Responsible Party: Françoise Wilhelmi de Toledo, Scientific Director; Principal Investigator, Buchinger Wilhelmi Development & Holding GmbH
ClinicalTrials.gov Identifier: NCT05031598    
Other Study ID Numbers: F-2021-075
First Posted: September 2, 2021    Key Record Dates
Last Update Posted: November 11, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Françoise Wilhelmi de Toledo, Buchinger Wilhelmi Development & Holding GmbH:
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