Clinical trial NCT05449249: Oral and Gut Microbiota Changes During Long-term Fasting in Humans
Official title: Oral and Gut Microbiota Changes During Long-term Fasting in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Periodontitis
Keywords: oral microbiota
intestinal microbiota
inflammatory status
redox status
sulfur metabolism
halitosis
Lead sponsor: Buchinger Wilhelmi Development & Holding GmbH
Sponsor class: OTHER
Collaborators: name: Buchinger Wilhelmi Clinic
name: University of Geneva, Switzerland
name: King's College London
name: ETH Zurich (Switzerland)
First posted: 2022-07-08
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single-arm, prospective, monocentric, interventional study
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in halitosis
timeFrame: daily from baseline to the 3rd day of food reintroduction
measure: Changes in microbiota compositions of subgingival microbial and plaque sampling
timeFrame: Baseline, fasting day 10, food reintroduction day 3
measure: Changes in microbiota composition in saliva
timeFrame: Baseline, fasting day 10, food reintroduction day 3, 1 and 3 months afterwards
measure: Changes in microbiota composition in faeces
timeFrame: Baseline, first spontaneous stool after food reintroduction (up to day 3), 1 and 3 months afterwards
measure: Changes in total antioxidant capacity (TAC)
timeFrame: Baseline, fasting day 3, 5, 10
measure: Changes in hydrogen sulfide production capacity
timeFrame: at the beginning and the end of fasting, on day 3 and 5, as well as at the food reintroduction
Secondary outcomes:
measure: Changes in glutathione (GSH)
timeFrame: Baseline, fasting day 3, 5, 10
measure: Changes in thiobarbituric acid reactive substances (TBARS)
timeFrame: Baseline, fasting day 3, 5, 10
measure: Changes in malondialdehyde (MDA)
timeFrame: Baseline, fasting day 3, 5, 10
measure: Changes in protein carbonyls
timeFrame: Baseline, fasting day 3, 5, 10
measure: Changes in nicotinamide adenine dinucleotide phosphate (NADPH) oxidase
timeFrame: Baseline, fasting day 3, 5, 10
measure: Changes in glutathione reductase (GR) activity
timeFrame: Baseline, fasting day 3, 5, 10
measure: Changes in glutathione peroxidase (GPx) activity
timeFrame: Baseline, fasting day 3, 5, 10
measure: Changes in peroxiredoxin activity
timeFrame: Baseline, fasting day 3, 5, 10
measure: Changes in catalase (CAT) activity
timeFrame: Baseline, fasting day 3, 5, 10
measure: Changes in superoxide dismutase (SOD) activity
timeFrame: Baseline, fasting day 3, 5, 10
measure: Changes in hydroxyl radical scavenging
timeFrame: Baseline, fasting day 3, 5, 10
measure: Changes in superoxydradical scavenging
timeFrame: Baseline, fasting day 3, 5, 10
measure: Changes in ABTS scavenging
timeFrame: Baseline, fasting day 3, 5, 10
measure: Changes in reducing power
timeFrame: Baseline, fasting day 3, 5, 10
measure: Changes in thiosulfate
timeFrame: Baseline, fasting day 10, food reintroduction day 3
measure: Changes in persulfidation
timeFrame: Baseline, fasting day 10, food reintroduction day 3
measure: Changes in cystein
timeFrame: Baseline, fasting day 10, food reintroduction day 3
measure: Changes in amino acid metabolites
timeFrame: Baseline, fasting day 10, food reintroduction day 3
measure: Changes in IL-10 in blood
timeFrame: Baseline, fasting day 10, food reintroduction day 3
measure: Changes in G-CSF in blood
timeFrame: Baseline, fasting day 10, food reintroduction day 3
measure: Changes in IFN-γ in blood
timeFrame: Baseline, fasting day 10, food reintroduction day 3
measure: Changes in TNF-α in blood
timeFrame: Baseline, fasting day 10, food reintroduction day 3
measure: Changes in IL-1β in blood
timeFrame: Baseline, fasting day 10, food reintroduction day 3
measure: Changes in IL-6 in blood
timeFrame: Baseline, fasting day 10, food reintroduction day 3
measure: Changes in IL-8 in blood
timeFrame: Baseline, fasting day 10, food reintroduction day 3
measure: Changes in IL-17 in blood
timeFrame: Baseline, fasting day 10, food reintroduction day 3
measure: Changes in IL-10 in gingival crevicular fluid
timeFrame: Baseline, fasting day 10, food reintroduction day 3
measure: Changes in G-CSF in gingival crevicular fluid
timeFrame: Baseline, fasting day 10, food reintroduction day 3
measure: Changes in IFN-γ in gingival crevicular fluid
timeFrame: Baseline, fasting day 10, food reintroduction day 3
measure: Changes in TNF-α in gingival crevicular fluid
timeFrame: Baseline, fasting day 10, food reintroduction day 3
measure: Changes in IL-1β in gingival crevicular fluid
timeFrame: Baseline, fasting day 10, food reintroduction day 3
measure: Changes in IL-6 in gingival crevicular fluid
timeFrame: Baseline, fasting day 10, food reintroduction day 3
measure: Changes in IL-8 in gingival crevicular fluid
timeFrame: Baseline, fasting day 10, food reintroduction day 3
measure: Changes in IL-17 in gingival crevicular fluid
timeFrame: Baseline, fasting day 10, food reintroduction day 3
Other outcomes:
measure: Changes in Rosenberg scale
timeFrame: daily from baseline to the 3rd day of food reintroduction
measure: Changes in Seemann scale
timeFrame: daily from baseline to the 3rd day of food reintroduction
measure: Changes in Ayurvedic diagnosis of the tongue
timeFrame: daily from baseline to the 3rd day of food reintroduction
measure: Changes in urinary ketone bodies
timeFrame: daily from baseline to the 3rd day of food reintroduction
measure: Changes in capillary blood ketones
timeFrame: daily from baseline to the 3rd day of food reintroduction
measure: Changes in capillary blood glucose
timeFrame: daily from baseline to the 3rd day of food reintroduction
measure: Changes in ph value of the urin
timeFrame: daily from baseline to the 3rd day of food reintroduction
measure: Changes in weight
timeFrame: daily from baseline to the 3rd day of food reintroduction as well as 1 and 3 months after
measure: Changes in blood pressure
timeFrame: daily from baseline to the 3rd day of food reintroduction as well as 1 and 3 months after
measure: Changes in pulse
timeFrame: daily from baseline to the 3rd day of food reintroduction as well as 1 and 3 months after
measure: Plaque Index score
timeFrame: baseline
measure: Gingival index score
timeFrame: baseline
measure: Probing pocket depth
timeFrame: baseline
measure: clinical attachment level
timeFrame: baseline
measure: recession
timeFrame: baseline
measure: Changes in leucocytes
timeFrame: Baseline, fasting day 10, and food reintroduction day 3
measure: Changes in erythrocytes
timeFrame: Baseline, fasting day 10, and food reintroduction day 3
measure: Changes in haemoglobin
timeFrame: Baseline, fasting day 10, and food reintroduction day 3
measure: Changes in haematocrit
timeFrame: Baseline, fasting day 10, and food reintroduction day 3
measure: Changes in MCV
timeFrame: Baseline, fasting day 10, and food reintroduction day 3
measure: Changes in MCH
timeFrame: Baseline, fasting day 10, and food reintroduction day 3
measure: Changes in MCHC
timeFrame: Baseline, fasting day 10, and food reintroduction day 3
measure: Changes in thrombocytes
timeFrame: Baseline, fasting day 10, and food reintroduction day 3
measure: Changes in international normalized ratio
timeFrame: Baseline, fasting day 10, and food reintroduction day 3
measure: Changes in Quick
timeFrame: Baseline, fasting day 10, and food reintroduction day 3
measure: Changes in partial thromboplastin time
timeFrame: Baseline, fasting day 10, and food reintroduction day 3
measure: Changes in aspartate aminotransferase (AST/GOT)
timeFrame: Baseline, fasting day 10, and food reintroduction day 3
measure: Changes in alanine aminotransferase (ALT/GPT)
timeFrame: Baseline, fasting day 10, and food reintroduction day 3
measure: Changes in gamma-glutamyl transferase (GGT)
timeFrame: Baseline, fasting day 10, and food reintroduction day 3
measure: Changes in alkaline phosphatase
timeFrame: Baseline, fasting day 10, and food reintroduction day 3
measure: Changes in uric acid
timeFrame: Baseline, fasting day 10, and food reintroduction day 3
measure: Changes in urea
timeFrame: Baseline, fasting day 10, and food reintroduction day 3
measure: Changes in glomerular Filtration Rate (GFR)
timeFrame: Baseline, fasting day 10, and food reintroduction day 3
measure: Changes in creatinine
timeFrame: Baseline, fasting day 10, and food reintroduction day 3
measure: Changes in thyroid-stimulating hormone (TSH)
timeFrame: Baseline, fasting day 10, and food reintroduction day 3
measure: Changes in total cholesterol
timeFrame: Baseline, fasting day 10, and food reintroduction day 3
measure: Changes in triglyceride
timeFrame: Baseline, fasting day 10, and food reintroduction day 3
measure: Changes in high-density lipoprotein (HDL)
timeFrame: Baseline, fasting day 10, and food reintroduction day 3
measure: Changes in low-density lipoprotein (LDL)
timeFrame: Baseline, fasting day 10, and food reintroduction day 3
measure: Changes in LDL / HDL - ratio
timeFrame: Baseline, fasting day 10, and food reintroduction day 3
measure: Changes in glucose
timeFrame: Baseline, fasting day 10, and food reintroduction day 3
measure: Changes in HbA1c
timeFrame: Baseline, fasting day 10, and food reintroduction day 3
measure: Changes in sodium
timeFrame: Baseline, fasting day 10, and food reintroduction day 3
measure: Changes in potassium
timeFrame: Baseline, fasting day 10, and food reintroduction day 3
measure: Changes in calcium
timeFrame: Baseline, fasting day 10, and food reintroduction day 3
measure: Changes in magnesium
timeFrame: Baseline, fasting day 10, and food reintroduction day 3
measure: Changes in erythrocyte sedimentation rate
timeFrame: Baseline, fasting day 10, and food reintroduction day 3
measure: Changes in C - reactive protein
timeFrame: Baseline, fasting day 10, and food reintroduction day 3
measure: Changes in pH value of saliva
timeFrame: Baseline, fasting day 10, food reintroduction day 3, 1 and 3 months afterwards
Locations:
city: Überlingen
country: Germany
facility: Buchinger Wilhelmi clinic
Study officials:
affiliation: Buchinger Wilhelmi
name: Françoise Wilhelmi de Toledo, MD
role: PRINCIPAL_INVESTIGATOR
References: