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Oral and Gut Microbiota Changes During Long-term Fasting in Humans (OralFast)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05449249
Recruitment Status : Completed
First Posted : July 8, 2022
Last Update Posted : January 13, 2023
Sponsor:
Collaborators:
Buchinger Wilhelmi Clinic
University of Geneva, Switzerland
King's College London
ETH Zurich (Switzerland)
Information provided by (Responsible Party):
Françoise Wilhelmi de Toledo, Buchinger Wilhelmi Development & Holding GmbH

Tracking Information
First Submitted Date  ICMJE June 29, 2022
First Posted Date  ICMJE July 8, 2022
Last Update Posted Date January 13, 2023
Actual Study Start Date  ICMJE September 1, 2022
Actual Primary Completion Date October 8, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 4, 2022)
  • Changes in halitosis [ Time Frame: daily from baseline to the 3rd day of food reintroduction ]
    Concentration of volatile sulfide compounds (hydrogen sulfide, methylmercaptan and dimethyl sulphide) using the OralChrome devise
  • Changes in microbiota compositions of subgingival microbial and plaque sampling [ Time Frame: Baseline, fasting day 10, food reintroduction day 3 ]
    Aggregatibacter actinomycetemcomitans (Aa), Porphyromonas (Pg), Tannerella forsythia (Tf), Treponema denticola (Td), Parvimonas micra (Pm) and Prevotella intermedia (Pi) analysed by RT-q-PCR
  • Changes in microbiota composition in saliva [ Time Frame: Baseline, fasting day 10, food reintroduction day 3, 1 and 3 months afterwards ]
    16 rRNA gene amplicon sequencing
  • Changes in microbiota composition in faeces [ Time Frame: Baseline, first spontaneous stool after food reintroduction (up to day 3), 1 and 3 months afterwards ]
    16 rRNA gene amplicon sequencing
  • Changes in total antioxidant capacity (TAC) [ Time Frame: Baseline, fasting day 3, 5, 10 ]
    (mmol DPPH/L)
  • Changes in hydrogen sulfide production capacity [ Time Frame: at the beginning and the end of fasting, on day 3 and 5, as well as at the food reintroduction ]
    measured in serum and urine using the lead acetate assay
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 4, 2022)
  • Changes in glutathione (GSH) [ Time Frame: Baseline, fasting day 3, 5, 10 ]
    (µmol/g Hb)
  • Changes in thiobarbituric acid reactive substances (TBARS) [ Time Frame: Baseline, fasting day 3, 5, 10 ]
    (µmol/L)
  • Changes in malondialdehyde (MDA) [ Time Frame: Baseline, fasting day 3, 5, 10 ]
    nM/L
  • Changes in protein carbonyls [ Time Frame: Baseline, fasting day 3, 5, 10 ]
    (nmol/mg protein)
  • Changes in nicotinamide adenine dinucleotide phosphate (NADPH) oxidase [ Time Frame: Baseline, fasting day 3, 5, 10 ]
    (µL)
  • Changes in glutathione reductase (GR) activity [ Time Frame: Baseline, fasting day 3, 5, 10 ]
    (U/g Hb)
  • Changes in glutathione peroxidase (GPx) activity [ Time Frame: Baseline, fasting day 3, 5, 10 ]
    (U/g Hb)
  • Changes in peroxiredoxin activity [ Time Frame: Baseline, fasting day 3, 5, 10 ]
    (U/g Hb)
  • Changes in catalase (CAT) activity [ Time Frame: Baseline, fasting day 3, 5, 10 ]
    (U/mg Hb)
  • Changes in superoxide dismutase (SOD) activity [ Time Frame: Baseline, fasting day 3, 5, 10 ]
    (U/g Hb)
  • Changes in hydroxyl radical scavenging [ Time Frame: Baseline, fasting day 3, 5, 10 ]
    (mmol deoxyribose/ml)
  • Changes in superoxydradical scavenging [ Time Frame: Baseline, fasting day 3, 5, 10 ]
    (mmol NBT/L plasma)
  • Changes in ABTS scavenging [ Time Frame: Baseline, fasting day 3, 5, 10 ]
    (mmol/L)
  • Changes in reducing power [ Time Frame: Baseline, fasting day 3, 5, 10 ]
    (mmol/L plasma)
  • Changes in thiosulfate [ Time Frame: Baseline, fasting day 10, food reintroduction day 3 ]
    measured using the monobromobimane method using HPLC and LC-MS/MS
  • Changes in persulfidation [ Time Frame: Baseline, fasting day 10, food reintroduction day 3 ]
    persulfidation in serum and urine
  • Changes in cystein [ Time Frame: Baseline, fasting day 10, food reintroduction day 3 ]
    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
  • Changes in amino acid metabolites [ Time Frame: Baseline, fasting day 10, food reintroduction day 3 ]
    using a targeted approach in serum and urine
  • Changes in IL-10 in blood [ Time Frame: Baseline, fasting day 10, food reintroduction day 3 ]
    analysed in blood with Bio-Plex 200 Suspension array System
  • Changes in G-CSF in blood [ Time Frame: Baseline, fasting day 10, food reintroduction day 3 ]
    analysed in blood with Bio-Plex 200 Suspension array System
  • Changes in IFN-γ in blood [ Time Frame: Baseline, fasting day 10, food reintroduction day 3 ]
    analysed in blood with Bio-Plex 200 Suspension array System
  • Changes in TNF-α in blood [ Time Frame: Baseline, fasting day 10, food reintroduction day 3 ]
    analysed in blood with Bio-Plex 200 Suspension array System
  • Changes in IL-1β in blood [ Time Frame: Baseline, fasting day 10, food reintroduction day 3 ]
    analysed in blood with Bio-Plex 200 Suspension array System
  • Changes in IL-6 in blood [ Time Frame: Baseline, fasting day 10, food reintroduction day 3 ]
    analysed in blood with Bio-Plex 200 Suspension array System
  • Changes in IL-8 in blood [ Time Frame: Baseline, fasting day 10, food reintroduction day 3 ]
    analysed in blood with Bio-Plex 200 Suspension array System
  • Changes in IL-17 in blood [ Time Frame: Baseline, fasting day 10, food reintroduction day 3 ]
    analysed in blood with Bio-Plex 200 Suspension array System
  • Changes in IL-10 in gingival crevicular fluid [ Time Frame: Baseline, fasting day 10, food reintroduction day 3 ]
    analysed in gingival crevicular fluid with Bio-Plex 200 Suspension array System
  • Changes in G-CSF in gingival crevicular fluid [ Time Frame: Baseline, fasting day 10, food reintroduction day 3 ]
    analysed in gingival crevicular fluid with Bio-Plex 200 Suspension array System
  • Changes in IFN-γ in gingival crevicular fluid [ Time Frame: Baseline, fasting day 10, food reintroduction day 3 ]
    analysed in gingival crevicular fluid with Bio-Plex 200 Suspension array System
  • Changes in TNF-α in gingival crevicular fluid [ Time Frame: Baseline, fasting day 10, food reintroduction day 3 ]
    analysed in gingival crevicular fluid with Bio-Plex 200 Suspension array System
  • Changes in IL-1β in gingival crevicular fluid [ Time Frame: Baseline, fasting day 10, food reintroduction day 3 ]
    analysed in gingival crevicular fluid with Bio-Plex 200 Suspension array System
  • Changes in IL-6 in gingival crevicular fluid [ Time Frame: Baseline, fasting day 10, food reintroduction day 3 ]
    analysed in gingival crevicular fluid with Bio-Plex 200 Suspension array System
  • Changes in IL-8 in gingival crevicular fluid [ Time Frame: Baseline, fasting day 10, food reintroduction day 3 ]
    analysed in gingival crevicular fluid with Bio-Plex 200 Suspension array System
  • Changes in IL-17 in gingival crevicular fluid [ Time Frame: Baseline, fasting day 10, food reintroduction day 3 ]
    analysed in gingival crevicular fluid with Bio-Plex 200 Suspension array System
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 4, 2022)
  • Changes in Rosenberg scale [ Time Frame: daily from baseline to the 3rd day of food reintroduction ]
    organoleptic intensity scale for measuring oral malodor: 0 = no odor to 5 = intense odor
  • Changes in Seemann scale [ Time Frame: daily from baseline to the 3rd day of food reintroduction ]
    organoleptic assessment: 1 = odor noticable from 10 cm to 3 = odor noticeable from 1m
  • Changes in Ayurvedic diagnosis of the tongue [ Time Frame: daily from baseline to the 3rd day of food reintroduction ]
    examination of the tongue
  • Changes in urinary ketone bodies [ Time Frame: daily from baseline to the 3rd day of food reintroduction ]
    using ketostix
  • Changes in capillary blood ketones [ Time Frame: daily from baseline to the 3rd day of food reintroduction ]
    using GlucoMen areo 2k
  • Changes in capillary blood glucose [ Time Frame: daily from baseline to the 3rd day of food reintroduction ]
    using GlucoMen areo 2k
  • Changes in ph value of the urin [ Time Frame: daily from baseline to the 3rd day of food reintroduction ]
    using test strips
  • Changes in weight [ Time Frame: daily from baseline to the 3rd day of food reintroduction as well as 1 and 3 months after ]
    kg
  • Changes in blood pressure [ Time Frame: daily from baseline to the 3rd day of food reintroduction as well as 1 and 3 months after ]
    systolic and diastolic in mmHg
  • Changes in pulse [ Time Frame: daily from baseline to the 3rd day of food reintroduction as well as 1 and 3 months after ]
    beats per minute
  • Plaque Index score [ Time Frame: baseline ]
    Sillness & Loe, 1964: from 0 = no plaque to 3 = abundant plaque along the gingival margin, interdental spaces filled with plaque
  • Gingival index score [ Time Frame: baseline ]
    Löe & Sillness, 1963: from 0 = normal gingiva to 3 = severe inflammation
  • Probing pocket depth [ Time Frame: baseline ]
    Bleeding on probing, recorded as present within 30 sec (1) or absent (0)
  • clinical attachment level [ Time Frame: baseline ]
    distance between the cemento-enamel junction and the tip of the graduated steel
  • recession [ Time Frame: baseline ]
    distance between CEJ and marginal edge of the free gingiva
  • Changes in leucocytes [ Time Frame: Baseline, fasting day 10, and food reintroduction day 3 ]
    (thousands/µl)
  • Changes in erythrocytes [ Time Frame: Baseline, fasting day 10, and food reintroduction day 3 ]
    (millions/µl)
  • Changes in haemoglobin [ Time Frame: Baseline, fasting day 10, and food reintroduction day 3 ]
    (g/dl)
  • Changes in haematocrit [ Time Frame: Baseline, fasting day 10, and food reintroduction day 3 ]
    (in %)
  • Changes in MCV [ Time Frame: Baseline, fasting day 10, and food reintroduction day 3 ]
    (fl)
  • Changes in MCH [ Time Frame: Baseline, fasting day 10, and food reintroduction day 3 ]
    (pg)
  • Changes in MCHC [ Time Frame: Baseline, fasting day 10, and food reintroduction day 3 ]
    (g/dl)
  • Changes in thrombocytes [ Time Frame: Baseline, fasting day 10, and food reintroduction day 3 ]
    (thousands/µl)
  • Changes in international normalized ratio [ Time Frame: Baseline, fasting day 10, and food reintroduction day 3 ]
    ratio
  • Changes in Quick [ Time Frame: Baseline, fasting day 10, and food reintroduction day 3 ]
    (in %)
  • Changes in partial thromboplastin time [ Time Frame: Baseline, fasting day 10, and food reintroduction day 3 ]
    (sec)
  • Changes in aspartate aminotransferase (AST/GOT) [ Time Frame: Baseline, fasting day 10, and food reintroduction day 3 ]
    (U/l)
  • Changes in alanine aminotransferase (ALT/GPT) [ Time Frame: Baseline, fasting day 10, and food reintroduction day 3 ]
    (U/l)
  • Changes in gamma-glutamyl transferase (GGT) [ Time Frame: Baseline, fasting day 10, and food reintroduction day 3 ]
    (U/l)
  • Changes in alkaline phosphatase [ Time Frame: Baseline, fasting day 10, and food reintroduction day 3 ]
    (U/l)
  • Changes in uric acid [ Time Frame: Baseline, fasting day 10, and food reintroduction day 3 ]
    (mg/dl)
  • Changes in urea [ Time Frame: Baseline, fasting day 10, and food reintroduction day 3 ]
    (mg/dl)
  • Changes in glomerular Filtration Rate (GFR) [ Time Frame: Baseline, fasting day 10, and food reintroduction day 3 ]
    (ml/min/1.73m2KOF)
  • Changes in creatinine [ Time Frame: Baseline, fasting day 10, and food reintroduction day 3 ]
    (mg/dl)
  • Changes in thyroid-stimulating hormone (TSH) [ Time Frame: Baseline, fasting day 10, and food reintroduction day 3 ]
    (mE/l)
  • Changes in total cholesterol [ Time Frame: Baseline, fasting day 10, and food reintroduction day 3 ]
    (mg/dl)
  • Changes in triglyceride [ Time Frame: Baseline, fasting day 10, and food reintroduction day 3 ]
    (mg/dl)
  • Changes in high-density lipoprotein (HDL) [ Time Frame: Baseline, fasting day 10, and food reintroduction day 3 ]
    (mg/dl)
  • Changes in low-density lipoprotein (LDL) [ Time Frame: Baseline, fasting day 10, and food reintroduction day 3 ]
    (mg/dl)
  • Changes in LDL / HDL - ratio [ Time Frame: Baseline, fasting day 10, and food reintroduction day 3 ]
    ratio
  • Changes in glucose [ Time Frame: Baseline, fasting day 10, and food reintroduction day 3 ]
    (mg/dl)
  • Changes in HbA1c [ Time Frame: Baseline, fasting day 10, and food reintroduction day 3 ]
    (mmol/mol)
  • Changes in sodium [ Time Frame: Baseline, fasting day 10, and food reintroduction day 3 ]
    (mmol/l)
  • Changes in potassium [ Time Frame: Baseline, fasting day 10, and food reintroduction day 3 ]
    (mmol/l)
  • Changes in calcium [ Time Frame: Baseline, fasting day 10, and food reintroduction day 3 ]
    (mmol/l)
  • Changes in magnesium [ Time Frame: Baseline, fasting day 10, and food reintroduction day 3 ]
    (mmol/l)
  • Changes in erythrocyte sedimentation rate [ Time Frame: Baseline, fasting day 10, and food reintroduction day 3 ]
    (mm/h)
  • Changes in C - reactive protein [ Time Frame: Baseline, fasting day 10, and food reintroduction day 3 ]
    (mg/l)
  • Changes in pH value of saliva [ Time Frame: Baseline, fasting day 10, food reintroduction day 3, 1 and 3 months afterwards ]
    (mol/l)
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Oral and Gut Microbiota Changes During Long-term Fasting in Humans
Official Title  ICMJE Oral and Gut Microbiota Changes During Long-term Fasting in Humans
Brief Summary The aim of this longitudinal trial is to investigate the effects of a 10±3-day fasting period in 30 subjects. Changes in the oral and gut microbiota, halitosis, as well as inflammatory and antioxidative parameters and biomarkers of sulfur metabolism will be analysed.
Detailed Description Fasting has been linked with changes in gut microbiota as part of the physiological adaptation. Furthermore, associations have been described between oral disease and nutrition (diet rich in carbohydrates). The aim of the present longitudinal clinical study is to explore the effect of a 10±3-day fasting period on the oral and gut microbiota. 30 systemically healthy subjects attending the Buchinger Wilhelmi Clinics for fasting, will participate. Changes in oral microbiota will be assessed in plaque and saliva samples and a number of inflammatory markers will be analyzed in Gingival Crevicular fluid (GCF) and blood obtained before, during and after the fasting period. The changes in the oral microbiota will be associated to the composition of the gut microbiota. Changes in periodontal parameters and halitosis related to the fasting period will be further evaluated. Given the known association between sulfur metabolism and the redox status, parameters from the antioxidant status and oxidative damages will also be assessed.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
single-arm, prospective, monocentric, interventional study
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Healthy
  • Periodontitis
Intervention  ICMJE Procedure: Long-term fasting
The participants will undergo a fasting program that includes the daily intake of 250 kcal under medical supervision.
Study Arms  ICMJE Experimental: Long-term fasting
Long-term fasting according to the Buchinger Wilhelmi fasting program.
Intervention: Procedure: Long-term fasting
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 12, 2023)		 36
Original Estimated Enrollment  ICMJE
 (submitted: July 4, 2022)		 30
Actual Study Completion Date  ICMJE January 6, 2023
Actual Primary Completion Date October 8, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Both subjects with periodontitis and healthy periodontium will be included.
  • Signed informed consent

Exclusion Criteria:

  • Not able to sign the informed consent
  • diagnosticated with cachexia, anorexia, nervosa, advanced kidney, liver or cerebrovascular insufficiency
  • Smoking
  • the intake of antibiotics within the last 8 weeks, as well as the intake of probiotics within the last 4 weeks
  • periodontal treatment in the last 6 months
  • chronic manifest psychical and psychiatric diseases
  • participation in another study
  • pregnancy or breastfeeding
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05449249
Other Study ID Numbers  ICMJE BuWi_OralFast_2022
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Françoise Wilhelmi de Toledo, Buchinger Wilhelmi Development & Holding GmbH
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Buchinger Wilhelmi Development & Holding GmbH
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Buchinger Wilhelmi Clinic
  • University of Geneva, Switzerland
  • King's College London
  • ETH Zurich (Switzerland)
Investigators  ICMJE
Principal Investigator: Françoise Wilhelmi de Toledo, MD Buchinger Wilhelmi
PRS Account Buchinger Wilhelmi Development & Holding GmbH
Verification Date January 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP