An interventional study of Long-term fasting in Healthy and Periodontitis, sponsored by Buchinger Wilhelmi Development & Holding GmbH. Completed at 1 site in Germany. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-13.
Sponsored by Buchinger Wilhelmi Development & Holding GmbH · Not applicable, Interventional, and Prevention
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.
1,231 studies on the registry are indexed under Periodontitis; 295 are open to participants now.
This study's enrollment of 36 is below the median of 44 across 846 interventional studies indexed under Periodontitis.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Long-term fasting according to the Buchinger Wilhelmi fasting program.
Procedure: Long-term fasting
The participants will undergo a fasting program that includes the daily intake of 250 kcal under medical supervision.
Changes in halitosis
Concentration of volatile sulfide compounds (hydrogen sulfide, methylmercaptan and dimethyl sulphide) using the OralChrome devise
Time frame: 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
Time frame: Baseline, fasting day 10, food reintroduction day 3
Changes in microbiota composition in saliva
16 rRNA gene amplicon sequencing
Time frame: Baseline, fasting day 10, food reintroduction day 3, 1 and 3 months afterwards
Changes in microbiota composition in faeces
16 rRNA gene amplicon sequencing
Time frame: 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)
Time frame: Baseline, fasting day 3, 5, 10
Changes in hydrogen sulfide production capacity
measured in serum and urine using the lead acetate assay
Time frame: at the beginning and the end of fasting, on day 3 and 5, as well as at the food reintroduction
Changes in glutathione (GSH)
(µmol/g Hb)
Time frame: Baseline, fasting day 3, 5, 10
Changes in thiobarbituric acid reactive substances (TBARS)
(µmol/L)
Time frame: Baseline, fasting day 3, 5, 10
Changes in malondialdehyde (MDA)
nM/L
Time frame: Baseline, fasting day 3, 5, 10
Changes in protein carbonyls
(nmol/mg protein)
Time frame: Baseline, fasting day 3, 5, 10
Changes in nicotinamide adenine dinucleotide phosphate (NADPH) oxidase
(µL)
Time frame: Baseline, fasting day 3, 5, 10
Changes in glutathione reductase (GR) activity
(U/g Hb)
Time frame: Baseline, fasting day 3, 5, 10
Changes in glutathione peroxidase (GPx) activity
(U/g Hb)
Time frame: Baseline, fasting day 3, 5, 10
Changes in peroxiredoxin activity
(U/g Hb)
Time frame: Baseline, fasting day 3, 5, 10
Changes in catalase (CAT) activity
(U/mg Hb)
Time frame: Baseline, fasting day 3, 5, 10
Changes in superoxide dismutase (SOD) activity
(U/g Hb)
Time frame: Baseline, fasting day 3, 5, 10
Changes in hydroxyl radical scavenging
(mmol deoxyribose/ml)
Time frame: Baseline, fasting day 3, 5, 10
Changes in superoxydradical scavenging
(mmol NBT/L plasma)
Time frame: Baseline, fasting day 3, 5, 10
Changes in ABTS scavenging
(mmol/L)
Time frame: Baseline, fasting day 3, 5, 10
Changes in reducing power
(mmol/L plasma)
Time frame: Baseline, fasting day 3, 5, 10
Changes in thiosulfate
measured using the monobromobimane method using HPLC and LC-MS/MS
Time frame: Baseline, fasting day 10, food reintroduction day 3
Changes in persulfidation
persulfidation in serum and urine
Time frame: 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
Time frame: Baseline, fasting day 10, food reintroduction day 3
Changes in amino acid metabolites
using a targeted approach in serum and urine
Time frame: Baseline, fasting day 10, food reintroduction day 3
Changes in IL-10 in blood
analysed in blood with Bio-Plex 200 Suspension array System
Time frame: Baseline, fasting day 10, food reintroduction day 3
Changes in G-CSF in blood
analysed in blood with Bio-Plex 200 Suspension array System
Time frame: Baseline, fasting day 10, food reintroduction day 3
Changes in IFN-γ in blood
analysed in blood with Bio-Plex 200 Suspension array System
Time frame: Baseline, fasting day 10, food reintroduction day 3
Changes in TNF-α in blood
analysed in blood with Bio-Plex 200 Suspension array System
Time frame: Baseline, fasting day 10, food reintroduction day 3
Changes in IL-1β in blood
analysed in blood with Bio-Plex 200 Suspension array System
Time frame: Baseline, fasting day 10, food reintroduction day 3
Changes in IL-6 in blood
analysed in blood with Bio-Plex 200 Suspension array System
Time frame: Baseline, fasting day 10, food reintroduction day 3
Changes in IL-8 in blood
analysed in blood with Bio-Plex 200 Suspension array System
Time frame: Baseline, fasting day 10, food reintroduction day 3
Changes in IL-17 in blood
analysed in blood with Bio-Plex 200 Suspension array System
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline, fasting day 10, food reintroduction day 3
Changes in Rosenberg scale
organoleptic intensity scale for measuring oral malodor: 0 = no odor to 5 = intense odor
Time frame: daily from baseline to the 3rd day of food reintroduction
Changes in Seemann scale
organoleptic assessment: 1 = odor noticable from 10 cm to 3 = odor noticeable from 1m
Time frame: daily from baseline to the 3rd day of food reintroduction
Changes in Ayurvedic diagnosis of the tongue
examination of the tongue
Time frame: daily from baseline to the 3rd day of food reintroduction
Changes in urinary ketone bodies
using ketostix
Time frame: daily from baseline to the 3rd day of food reintroduction
Changes in capillary blood ketones
using GlucoMen areo 2k
Time frame: daily from baseline to the 3rd day of food reintroduction
Changes in capillary blood glucose
using GlucoMen areo 2k
Time frame: daily from baseline to the 3rd day of food reintroduction
Changes in ph value of the urin
using test strips
Time frame: daily from baseline to the 3rd day of food reintroduction
Changes in weight
kg
Time frame: 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
Time frame: daily from baseline to the 3rd day of food reintroduction as well as 1 and 3 months after
Changes in pulse
beats per minute
Time frame: 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
Time frame: baseline
Gingival index score
Löe \& Sillness, 1963: from 0 = normal gingiva to 3 = severe inflammation
Time frame: baseline
Probing pocket depth
Bleeding on probing, recorded as present within 30 sec (1) or absent (0)
Time frame: baseline
clinical attachment level
distance between the cemento-enamel junction and the tip of the graduated steel
Time frame: baseline
recession
distance between CEJ and marginal edge of the free gingiva
Time frame: baseline
Changes in leucocytes
(thousands/µl)
Time frame: Baseline, fasting day 10, and food reintroduction day 3
Changes in erythrocytes
(millions/µl)
Time frame: Baseline, fasting day 10, and food reintroduction day 3
Changes in haemoglobin
(g/dl)
Time frame: Baseline, fasting day 10, and food reintroduction day 3
Changes in haematocrit
(in %)
Time frame: Baseline, fasting day 10, and food reintroduction day 3
Changes in MCV
(fl)
Time frame: Baseline, fasting day 10, and food reintroduction day 3
Changes in MCH
(pg)
Time frame: Baseline, fasting day 10, and food reintroduction day 3
Changes in MCHC
(g/dl)
Time frame: Baseline, fasting day 10, and food reintroduction day 3
Changes in thrombocytes
(thousands/µl)
Time frame: Baseline, fasting day 10, and food reintroduction day 3
Changes in international normalized ratio
ratio
Time frame: Baseline, fasting day 10, and food reintroduction day 3
Changes in Quick
(in %)
Time frame: Baseline, fasting day 10, and food reintroduction day 3
Changes in partial thromboplastin time
(sec)
Time frame: Baseline, fasting day 10, and food reintroduction day 3
Changes in aspartate aminotransferase (AST/GOT)
(U/l)
Time frame: Baseline, fasting day 10, and food reintroduction day 3
Changes in alanine aminotransferase (ALT/GPT)
(U/l)
Time frame: Baseline, fasting day 10, and food reintroduction day 3
Changes in gamma-glutamyl transferase (GGT)
(U/l)
Time frame: Baseline, fasting day 10, and food reintroduction day 3
Changes in alkaline phosphatase
(U/l)
Time frame: Baseline, fasting day 10, and food reintroduction day 3
Changes in uric acid
(mg/dl)
Time frame: Baseline, fasting day 10, and food reintroduction day 3
Changes in urea
(mg/dl)
Time frame: Baseline, fasting day 10, and food reintroduction day 3
Changes in glomerular Filtration Rate (GFR)
(ml/min/1.73m2KOF)
Time frame: Baseline, fasting day 10, and food reintroduction day 3
Changes in creatinine
(mg/dl)
Time frame: Baseline, fasting day 10, and food reintroduction day 3
Changes in thyroid-stimulating hormone (TSH)
(mE/l)
Time frame: Baseline, fasting day 10, and food reintroduction day 3
Changes in total cholesterol
(mg/dl)
Time frame: Baseline, fasting day 10, and food reintroduction day 3
Changes in triglyceride
(mg/dl)
Time frame: Baseline, fasting day 10, and food reintroduction day 3
Changes in high-density lipoprotein (HDL)
(mg/dl)
Time frame: Baseline, fasting day 10, and food reintroduction day 3
Changes in low-density lipoprotein (LDL)
(mg/dl)
Time frame: Baseline, fasting day 10, and food reintroduction day 3
Changes in LDL / HDL - ratio
ratio
Time frame: Baseline, fasting day 10, and food reintroduction day 3
Changes in glucose
(mg/dl)
Time frame: Baseline, fasting day 10, and food reintroduction day 3
Changes in HbA1c
(mmol/mol)
Time frame: Baseline, fasting day 10, and food reintroduction day 3
Changes in sodium
(mmol/l)
Time frame: Baseline, fasting day 10, and food reintroduction day 3
Changes in potassium
(mmol/l)
Time frame: Baseline, fasting day 10, and food reintroduction day 3
Changes in calcium
(mmol/l)
Time frame: Baseline, fasting day 10, and food reintroduction day 3
Changes in magnesium
(mmol/l)
Time frame: Baseline, fasting day 10, and food reintroduction day 3
Changes in erythrocyte sedimentation rate
(mm/h)
Time frame: Baseline, fasting day 10, and food reintroduction day 3
Changes in C - reactive protein
(mg/l)
Time frame: Baseline, fasting day 10, and food reintroduction day 3
Changes in pH value of saliva
(mol/l)
Time frame: Baseline, fasting day 10, food reintroduction day 3, 1 and 3 months afterwards
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Buchinger Wilhelmi Development & Holding GmbH