Oral and Gut Microbiota Changes During Long-term Fasting in Humans
- Conditions
- PeriodontitisHealthy
- Interventions
- Procedure: Long-term fasting
- Registration Number
- NCT05449249
- Lead Sponsor
- Buchinger Wilhelmi Development & Holding GmbH
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
- Both subjects with periodontitis and healthy periodontium will be included.
- Signed informed consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Long-term fasting Long-term fasting Long-term fasting according to the Buchinger Wilhelmi fasting program.
- Primary Outcome Measures
Name Time Method Changes in total antioxidant capacity (TAC) Baseline, fasting day 3, 5, 10 (mmol DPPH/L)
Changes in halitosis 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 composition in faeces Baseline, first spontaneous stool after food reintroduction (up to day 3), 1 and 3 months afterwards 16 rRNA gene amplicon sequencing
Changes in hydrogen sulfide production capacity 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
Changes in microbiota compositions of subgingival microbial and plaque sampling 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 Baseline, fasting day 10, food reintroduction day 3, 1 and 3 months afterwards 16 rRNA gene amplicon sequencing
- Secondary Outcome Measures
Name Time Method Changes in amino acid metabolites Baseline, fasting day 10, food reintroduction day 3 using a targeted approach in serum and urine
Changes in persulfidation Baseline, fasting day 10, food reintroduction day 3 persulfidation in serum and urine
Changes in glutathione peroxidase (GPx) activity Baseline, fasting day 3, 5, 10 (U/g Hb)
Changes in IFN-γ in blood Baseline, fasting day 10, food reintroduction day 3 analysed in blood with Bio-Plex 200 Suspension array System
Changes in glutathione (GSH) Baseline, fasting day 3, 5, 10 (µmol/g Hb)
Changes in malondialdehyde (MDA) Baseline, fasting day 3, 5, 10 nM/L
Changes in peroxiredoxin activity Baseline, fasting day 3, 5, 10 (U/g Hb)
Changes in hydroxyl radical scavenging Baseline, fasting day 3, 5, 10 (mmol deoxyribose/ml)
Changes in glutathione reductase (GR) activity Baseline, fasting day 3, 5, 10 (U/g Hb)
Changes in catalase (CAT) activity Baseline, fasting day 3, 5, 10 (U/mg Hb)
Changes in thiobarbituric acid reactive substances (TBARS) Baseline, fasting day 3, 5, 10 (µmol/L)
Changes in thiosulfate Baseline, fasting day 10, food reintroduction day 3 measured using the monobromobimane method using HPLC and LC-MS/MS
Changes in protein carbonyls Baseline, fasting day 3, 5, 10 (nmol/mg protein)
Changes in nicotinamide adenine dinucleotide phosphate (NADPH) oxidase Baseline, fasting day 3, 5, 10 (µL)
Changes in superoxide dismutase (SOD) activity Baseline, fasting day 3, 5, 10 (U/g Hb)
Changes in IL-17 in gingival crevicular fluid 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 blood Baseline, fasting day 10, food reintroduction day 3 analysed in blood with Bio-Plex 200 Suspension array System
Changes in G-CSF in blood Baseline, fasting day 10, food reintroduction day 3 analysed in blood with Bio-Plex 200 Suspension array System
Changes in TNF-α in blood 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 Baseline, fasting day 10, food reintroduction day 3 analysed in gingival crevicular fluid with Bio-Plex 200 Suspension array System
Changes in superoxydradical scavenging Baseline, fasting day 3, 5, 10 (mmol NBT/L plasma)
Changes in IL-6 in blood Baseline, fasting day 10, food reintroduction day 3 analysed in blood with Bio-Plex 200 Suspension array System
Changes in IL-8 in blood Baseline, fasting day 10, food reintroduction day 3 analysed in blood with Bio-Plex 200 Suspension array System
Changes in G-CSF in gingival crevicular fluid 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 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 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 Baseline, fasting day 10, food reintroduction day 3 analysed in gingival crevicular fluid with Bio-Plex 200 Suspension array System
Changes in ABTS scavenging Baseline, fasting day 3, 5, 10 (mmol/L)
Changes in reducing power Baseline, fasting day 3, 5, 10 (mmol/L plasma)
Changes in cystein 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 IL-10 in blood Baseline, fasting day 10, food reintroduction day 3 analysed in blood with Bio-Plex 200 Suspension array System
Changes in IL-1β in blood Baseline, fasting day 10, food reintroduction day 3 analysed in blood with Bio-Plex 200 Suspension array System
Changes in IFN-γ in gingival crevicular fluid 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 Baseline, fasting day 10, food reintroduction day 3 analysed in gingival crevicular fluid with Bio-Plex 200 Suspension array System
Trial Locations
- Locations (1)
Buchinger Wilhelmi clinic
🇩🇪Überlingen, Germany