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| Name | Class |
|---|---|
| Buchinger Wilhelmi Clinic | UNKNOWN |
| University of Geneva, Switzerland | OTHER |
| King's College London | OTHER |
| ETH Zurich (Switzerland) |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Long-term fasting | Experimental | Long-term fasting according to the Buchinger Wilhelmi fasting program. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Long-term fasting | Procedure | The participants will undergo a fasting program that includes the daily intake of 250 kcal under medical supervision. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in halitosis | Concentration of volatile sulfide compounds (hydrogen sulfide, methylmercaptan and dimethyl sulphide) using the OralChrome devise | daily from baseline to the 3rd day of food reintroduction |
| Changes in microbiota compositions of subgingival microbial and plaque sampling | Aggregatibacter actinomycetemcomitans (Aa), Porphyromonas (Pg), Tannerella forsythia (Tf), Treponema denticola (Td), Parvimonas micra (Pm) and Prevotella intermedia (Pi) analysed by RT-q-PCR | Baseline, fasting day 10, food reintroduction day 3 |
| Changes in microbiota composition in saliva | 16 rRNA gene amplicon sequencing | Baseline, fasting day 10, food reintroduction day 3, 1 and 3 months afterwards |
| Changes in microbiota composition in faeces | 16 rRNA gene amplicon sequencing | Baseline, first spontaneous stool after food reintroduction (up to day 3), 1 and 3 months afterwards |
| Changes in total antioxidant capacity (TAC) | (mmol DPPH/L) | Baseline, fasting day 3, 5, 10 |
| Changes in hydrogen sulfide production capacity | measured in serum and urine using the lead acetate assay | at the beginning and the end of fasting, on day 3 and 5, as well as at the food reintroduction |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in glutathione (GSH) | (µmol/g Hb) | Baseline, fasting day 3, 5, 10 |
| Changes in thiobarbituric acid reactive substances (TBARS) | (µmol/L) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Rosenberg scale | organoleptic intensity scale for measuring oral malodor: 0 = no odor to 5 = intense odor | daily from baseline to the 3rd day of food reintroduction |
| Changes in Seemann scale |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Françoise Wilhelmi de Toledo, MD | Buchinger Wilhelmi | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Buchinger Wilhelmi clinic | Überlingen | 88662 | Germany |
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D006209 | Halitosis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D012817 | Signs and Symptoms, Digestive |
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| OTHER |
single-arm, prospective, monocentric, interventional study
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| Baseline, fasting day 3, 5, 10 |
| Changes in malondialdehyde (MDA) | nM/L | Baseline, fasting day 3, 5, 10 |
| Changes in protein carbonyls | (nmol/mg protein) | Baseline, fasting day 3, 5, 10 |
| Changes in nicotinamide adenine dinucleotide phosphate (NADPH) oxidase | (µL) | Baseline, fasting day 3, 5, 10 |
| Changes in glutathione reductase (GR) activity | (U/g Hb) | Baseline, fasting day 3, 5, 10 |
| Changes in glutathione peroxidase (GPx) activity | (U/g Hb) | Baseline, fasting day 3, 5, 10 |
| Changes in peroxiredoxin activity | (U/g Hb) | Baseline, fasting day 3, 5, 10 |
| Changes in catalase (CAT) activity | (U/mg Hb) | Baseline, fasting day 3, 5, 10 |
| Changes in superoxide dismutase (SOD) activity | (U/g Hb) | Baseline, fasting day 3, 5, 10 |
| Changes in hydroxyl radical scavenging | (mmol deoxyribose/ml) | Baseline, fasting day 3, 5, 10 |
| Changes in superoxydradical scavenging | (mmol NBT/L plasma) | Baseline, fasting day 3, 5, 10 |
| Changes in ABTS scavenging | (mmol/L) | Baseline, fasting day 3, 5, 10 |
| Changes in reducing power | (mmol/L plasma) | Baseline, fasting day 3, 5, 10 |
| Changes in thiosulfate | measured using the monobromobimane method using HPLC and LC-MS/MS | Baseline, fasting day 10, food reintroduction day 3 |
| Changes in persulfidation | persulfidation in serum and urine | Baseline, fasting day 10, food reintroduction day 3 |
| Changes in cystein | 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 | Baseline, fasting day 10, food reintroduction day 3 |
| Changes in amino acid metabolites | using a targeted approach in serum and urine | Baseline, fasting day 10, food reintroduction day 3 |
| Changes in IL-10 in blood | analysed in blood with Bio-Plex 200 Suspension array System | Baseline, fasting day 10, food reintroduction day 3 |
| Changes in G-CSF in blood | analysed in blood with Bio-Plex 200 Suspension array System | Baseline, fasting day 10, food reintroduction day 3 |
| Changes in IFN-γ in blood | analysed in blood with Bio-Plex 200 Suspension array System | Baseline, fasting day 10, food reintroduction day 3 |
| Changes in TNF-α in blood | analysed in blood with Bio-Plex 200 Suspension array System | Baseline, fasting day 10, food reintroduction day 3 |
| Changes in IL-1β in blood | analysed in blood with Bio-Plex 200 Suspension array System | Baseline, fasting day 10, food reintroduction day 3 |
| Changes in IL-6 in blood | analysed in blood with Bio-Plex 200 Suspension array System | Baseline, fasting day 10, food reintroduction day 3 |
| Changes in IL-8 in blood | analysed in blood with Bio-Plex 200 Suspension array System | Baseline, fasting day 10, food reintroduction day 3 |
| Changes in IL-17 in blood | analysed in blood with Bio-Plex 200 Suspension array System | Baseline, fasting day 10, food reintroduction day 3 |
| Changes in IL-10 in gingival crevicular fluid | analysed in gingival crevicular fluid with Bio-Plex 200 Suspension array System | Baseline, fasting day 10, food reintroduction day 3 |
| Changes in G-CSF in gingival crevicular fluid | analysed in gingival crevicular fluid with Bio-Plex 200 Suspension array System | Baseline, fasting day 10, food reintroduction day 3 |
| Changes in IFN-γ in gingival crevicular fluid | analysed in gingival crevicular fluid with Bio-Plex 200 Suspension array System | Baseline, fasting day 10, food reintroduction day 3 |
| Changes in TNF-α in gingival crevicular fluid | analysed in gingival crevicular fluid with Bio-Plex 200 Suspension array System | Baseline, fasting day 10, food reintroduction day 3 |
| Changes in IL-1β in gingival crevicular fluid | analysed in gingival crevicular fluid with Bio-Plex 200 Suspension array System | Baseline, fasting day 10, food reintroduction day 3 |
| Changes in IL-6 in gingival crevicular fluid | analysed in gingival crevicular fluid with Bio-Plex 200 Suspension array System | Baseline, fasting day 10, food reintroduction day 3 |
| Changes in IL-8 in gingival crevicular fluid | analysed in gingival crevicular fluid with Bio-Plex 200 Suspension array System | Baseline, fasting day 10, food reintroduction day 3 |
| Changes in IL-17 in gingival crevicular fluid | analysed in gingival crevicular fluid with Bio-Plex 200 Suspension array System | Baseline, fasting day 10, food reintroduction day 3 |
organoleptic assessment: 1 = odor noticable from 10 cm to 3 = odor noticeable from 1m
| daily from baseline to the 3rd day of food reintroduction |
| Changes in Ayurvedic diagnosis of the tongue | examination of the tongue | daily from baseline to the 3rd day of food reintroduction |
| Changes in urinary ketone bodies | using ketostix | daily from baseline to the 3rd day of food reintroduction |
| Changes in capillary blood ketones | using GlucoMen areo 2k | daily from baseline to the 3rd day of food reintroduction |
| Changes in capillary blood glucose | using GlucoMen areo 2k | daily from baseline to the 3rd day of food reintroduction |
| Changes in ph value of the urin | using test strips | daily from baseline to the 3rd day of food reintroduction |
| Changes in weight | kg | daily from baseline to the 3rd day of food reintroduction as well as 1 and 3 months after |
| Changes in blood pressure | systolic and diastolic in mmHg | daily from baseline to the 3rd day of food reintroduction as well as 1 and 3 months after |
| Changes in pulse | beats per minute | daily from baseline to the 3rd day of food reintroduction as well as 1 and 3 months after |
| Plaque Index score | Sillness & Loe, 1964: from 0 = no plaque to 3 = abundant plaque along the gingival margin, interdental spaces filled with plaque | baseline |
| Gingival index score | Löe & Sillness, 1963: from 0 = normal gingiva to 3 = severe inflammation | baseline |
| Probing pocket depth | Bleeding on probing, recorded as present within 30 sec (1) or absent (0) | baseline |
| clinical attachment level | distance between the cemento-enamel junction and the tip of the graduated steel | baseline |
| recession | distance between CEJ and marginal edge of the free gingiva | baseline |
| Changes in leucocytes | (thousands/µl) | Baseline, fasting day 10, and food reintroduction day 3 |
| Changes in erythrocytes | (millions/µl) | Baseline, fasting day 10, and food reintroduction day 3 |
| Changes in haemoglobin | (g/dl) | Baseline, fasting day 10, and food reintroduction day 3 |
| Changes in haematocrit | (in %) | Baseline, fasting day 10, and food reintroduction day 3 |
| Changes in MCV | (fl) | Baseline, fasting day 10, and food reintroduction day 3 |
| Changes in MCH | (pg) | Baseline, fasting day 10, and food reintroduction day 3 |
| Changes in MCHC | (g/dl) | Baseline, fasting day 10, and food reintroduction day 3 |
| Changes in thrombocytes | (thousands/µl) | Baseline, fasting day 10, and food reintroduction day 3 |
| Changes in international normalized ratio | ratio | Baseline, fasting day 10, and food reintroduction day 3 |
| Changes in Quick | (in %) | Baseline, fasting day 10, and food reintroduction day 3 |
| Changes in partial thromboplastin time | (sec) | Baseline, fasting day 10, and food reintroduction day 3 |
| Changes in aspartate aminotransferase (AST/GOT) | (U/l) | Baseline, fasting day 10, and food reintroduction day 3 |
| Changes in alanine aminotransferase (ALT/GPT) | (U/l) | Baseline, fasting day 10, and food reintroduction day 3 |
| Changes in gamma-glutamyl transferase (GGT) | (U/l) | Baseline, fasting day 10, and food reintroduction day 3 |
| Changes in alkaline phosphatase | (U/l) | Baseline, fasting day 10, and food reintroduction day 3 |
| Changes in uric acid | (mg/dl) | Baseline, fasting day 10, and food reintroduction day 3 |
| Changes in urea | (mg/dl) | Baseline, fasting day 10, and food reintroduction day 3 |
| Changes in glomerular Filtration Rate (GFR) | (ml/min/1.73m2KOF) | Baseline, fasting day 10, and food reintroduction day 3 |
| Changes in creatinine | (mg/dl) | Baseline, fasting day 10, and food reintroduction day 3 |
| Changes in thyroid-stimulating hormone (TSH) | (mE/l) | Baseline, fasting day 10, and food reintroduction day 3 |
| Changes in total cholesterol | (mg/dl) | Baseline, fasting day 10, and food reintroduction day 3 |
| Changes in triglyceride | (mg/dl) | Baseline, fasting day 10, and food reintroduction day 3 |
| Changes in high-density lipoprotein (HDL) | (mg/dl) | Baseline, fasting day 10, and food reintroduction day 3 |
| Changes in low-density lipoprotein (LDL) | (mg/dl) | Baseline, fasting day 10, and food reintroduction day 3 |
| Changes in LDL / HDL - ratio | ratio | Baseline, fasting day 10, and food reintroduction day 3 |
| Changes in glucose | (mg/dl) | Baseline, fasting day 10, and food reintroduction day 3 |
| Changes in HbA1c | (mmol/mol) | Baseline, fasting day 10, and food reintroduction day 3 |
| Changes in sodium | (mmol/l) | Baseline, fasting day 10, and food reintroduction day 3 |
| Changes in potassium | (mmol/l) | Baseline, fasting day 10, and food reintroduction day 3 |
| Changes in calcium | (mmol/l) | Baseline, fasting day 10, and food reintroduction day 3 |
| Changes in magnesium | (mmol/l) | Baseline, fasting day 10, and food reintroduction day 3 |
| Changes in erythrocyte sedimentation rate | (mm/h) | Baseline, fasting day 10, and food reintroduction day 3 |
| Changes in C - reactive protein | (mg/l) | Baseline, fasting day 10, and food reintroduction day 3 |
| Changes in pH value of saliva | (mol/l) | Baseline, fasting day 10, food reintroduction day 3, 1 and 3 months afterwards |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |