HealthyOralFastNCT05449249
Oral and Gut Microbiota Changes During Long-term Fasting in Humans
A study testing Long-term fasting in people with Healthy and Periodontitis, run by Buchinger Wilhelmi Development & Holding GmbH at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Periodontitis
- What is being tested?
- Long-term fasting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2022to 6 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Both subjects with periodontitis and healthy periodontium will be included.
- Signed informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Healthy, Periodontitis
- Being tested
- Long-term fasting
- Keywords
- oral microbiota, intestinal microbiota, inflammatory status, redox status, sulfur metabolism, halitosis
- Medical subject headings
- Periodontitis, Halitosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long-term fastingProcedure or surgery
The participants will undergo a fasting program that includes the daily intake of 250 kcal under medical supervision.
| Study group | Role | What they receive |
|---|---|---|
| Long-term fasting | Experimental | Long-term fasting according to the Buchinger Wilhelmi fasting program. Receives: Procedure: Long-term fasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in halitosis
Concentration of volatile sulfide compounds (hydrogen sulfide, methylmercaptan and dimethyl sulphide) using the OralChrome devise
Measured: 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
Measured: Baseline, fasting day 10, food reintroduction day 3
Changes in microbiota composition in saliva
16 rRNA gene amplicon sequencing
Measured: Baseline, fasting day 10, food reintroduction day 3, 1 and 3 months afterwards
Changes in microbiota composition in faeces
16 rRNA gene amplicon sequencing
Measured: 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)
Measured: Baseline, fasting day 3, 5, 10
Changes in hydrogen sulfide production capacity
measured in serum and urine using the lead acetate assay
Measured: at the beginning and the end of fasting, on day 3 and 5, as well as at the food reintroduction
Secondary outcomes (34)
Changes in glutathione (GSH)
(µmol/g Hb)
Measured: Baseline, fasting day 3, 5, 10
Changes in thiobarbituric acid reactive substances (TBARS)
(µmol/L)
Measured: Baseline, fasting day 3, 5, 10
Changes in malondialdehyde (MDA)
nM/L
Measured: Baseline, fasting day 3, 5, 10
Changes in protein carbonyls
(nmol/mg protein)
Measured: Baseline, fasting day 3, 5, 10
Changes in nicotinamide adenine dinucleotide phosphate (NADPH) oxidase
(µL)
Measured: Baseline, fasting day 3, 5, 10
Changes in glutathione reductase (GR) activity
(U/g Hb)
Measured: Baseline, fasting day 3, 5, 10
Changes in glutathione peroxidase (GPx) activity
(U/g Hb)
Measured: Baseline, fasting day 3, 5, 10
Changes in peroxiredoxin activity
(U/g Hb)
Measured: Baseline, fasting day 3, 5, 10
Changes in catalase (CAT) activity
(U/mg Hb)
Measured: Baseline, fasting day 3, 5, 10
Changes in superoxide dismutase (SOD) activity
(U/g Hb)
Measured: Baseline, fasting day 3, 5, 10
Changes in hydroxyl radical scavenging
(mmol deoxyribose/ml)
Measured: Baseline, fasting day 3, 5, 10
Changes in superoxydradical scavenging
(mmol NBT/L plasma)
Measured: Baseline, fasting day 3, 5, 10
Changes in ABTS scavenging
(mmol/L)
Measured: Baseline, fasting day 3, 5, 10
Changes in reducing power
(mmol/L plasma)
Measured: Baseline, fasting day 3, 5, 10
Changes in thiosulfate
measured using the monobromobimane method using HPLC and LC-MS/MS
Measured: Baseline, fasting day 10, food reintroduction day 3
Changes in persulfidation
persulfidation in serum and urine
Measured: 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
Measured: Baseline, fasting day 10, food reintroduction day 3
Changes in amino acid metabolites
using a targeted approach in serum and urine
Measured: Baseline, fasting day 10, food reintroduction day 3
Changes in IL-10 in blood
analysed in blood with Bio-Plex 200 Suspension array System
Measured: Baseline, fasting day 10, food reintroduction day 3
Changes in G-CSF in blood
analysed in blood with Bio-Plex 200 Suspension array System
Measured: Baseline, fasting day 10, food reintroduction day 3
Changes in IFN-γ in blood
analysed in blood with Bio-Plex 200 Suspension array System
Measured: Baseline, fasting day 10, food reintroduction day 3
Changes in TNF-α in blood
analysed in blood with Bio-Plex 200 Suspension array System
Measured: Baseline, fasting day 10, food reintroduction day 3
Changes in IL-1β in blood
analysed in blood with Bio-Plex 200 Suspension array System
Measured: Baseline, fasting day 10, food reintroduction day 3
Changes in IL-6 in blood
analysed in blood with Bio-Plex 200 Suspension array System
Measured: Baseline, fasting day 10, food reintroduction day 3
Changes in IL-8 in blood
analysed in blood with Bio-Plex 200 Suspension array System
Measured: Baseline, fasting day 10, food reintroduction day 3
Changes in IL-17 in blood
analysed in blood with Bio-Plex 200 Suspension array System
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, fasting day 10, food reintroduction day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study start1 Sep 2022
- Primary completion8 Oct 2022
- Study completion6 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single-arm, prospective, monocentric, interventional study
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Buchinger Wilhelmi Development & Holding GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- University of Geneva, Switzerland, King's College London, ETH Zurich (Switzerland)
- Responsible party
- Principal investigator, Françoise Wilhelmi de Toledo, Buchinger Wilhelmi Development & Holding GmbH
- Investigators
- Françoise Wilhelmi de Toledo, MD, Principal investigator, Buchinger Wilhelmi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05449249
- Sponsor's protocol ID
- BuWi_OralFast_2022
- Acronym
- OralFast
- Status last verified
- Jan 2023
- First submitted
- 29 Jun 2022
- Last updated
- 13 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral and Gut Microbiota Changes During Long-term Fasting in Humans
- ClinicalTrials.gov ID
- NCT05449249
- Acronym / sponsor ID
- OralFast / BuWi_OralFast_2022
- Conditions
- Healthy, Periodontitis
- Keywords
- oral microbiota, intestinal microbiota, inflammatory status, redox status, sulfur metabolism, halitosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Buchinger Wilhelmi Development & Holding GmbHUniversity, hospital or other
- Collaborators
- University of Geneva, Switzerland, King's College London, ETH Zurich (Switzerland)
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 8 Oct 2022 (actual)
- Study completion
- 6 Jan 2023 (actual)
- First posted
- 8 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single-arm, prospective, monocentric, interventional study
| Arm | Type | Receives |
|---|---|---|
| Long-term fasting | Experimental | Procedure: Long-term fastingLong-term fasting according to the Buchinger Wilhelmi fasting program. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Both subjects with periodontitis and healthy periodontium will be included.
- Signed informed consent
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Long-term fastingThe participants will undergo a fasting program that includes the daily intake of 250 kcal under medical supervision. | Procedure or surgery | Long-term fasting |
Primary outcome
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
34 secondary outcomes
Changes in glutathione (GSH)
Time frame: Baseline, fasting day 3, 5, 10
Changes in thiobarbituric acid reactive substances (TBARS)
Time frame: Baseline, fasting day 3, 5, 10
Changes in malondialdehyde (MDA)
Time frame: Baseline, fasting day 3, 5, 10
Changes in protein carbonyls
Time frame: Baseline, fasting day 3, 5, 10
Changes in nicotinamide adenine dinucleotide phosphate (NADPH) oxidase
Time frame: Baseline, fasting day 3, 5, 10
Changes in glutathione reductase (GR) activity
Time frame: Baseline, fasting day 3, 5, 10
Changes in glutathione peroxidase (GPx) activity
Time frame: Baseline, fasting day 3, 5, 10
Changes in peroxiredoxin activity
Time frame: Baseline, fasting day 3, 5, 10
Changes in catalase (CAT) activity
Time frame: Baseline, fasting day 3, 5, 10
Changes in superoxide dismutase (SOD) activity
Time frame: Baseline, fasting day 3, 5, 10
Changes in hydroxyl radical scavenging
Time frame: Baseline, fasting day 3, 5, 10
Changes in superoxydradical scavenging
Time frame: Baseline, fasting day 3, 5, 10
Changes in ABTS scavenging
Time frame: Baseline, fasting day 3, 5, 10
Changes in reducing power
Time frame: Baseline, fasting day 3, 5, 10
Changes in thiosulfate
Time frame: Baseline, fasting day 10, food reintroduction day 3
Changes in persulfidation
Time frame: Baseline, fasting day 10, food reintroduction day 3
Changes in cystein
Time frame: Baseline, fasting day 10, food reintroduction day 3
Changes in amino acid metabolites
Time frame: Baseline, fasting day 10, food reintroduction day 3
Changes in IL-10 in blood
Time frame: Baseline, fasting day 10, food reintroduction day 3
Changes in G-CSF in blood
Time frame: Baseline, fasting day 10, food reintroduction day 3
Changes in IFN-γ in blood
Time frame: Baseline, fasting day 10, food reintroduction day 3
Changes in TNF-α in blood
Time frame: Baseline, fasting day 10, food reintroduction day 3
Changes in IL-1β in blood
Time frame: Baseline, fasting day 10, food reintroduction day 3
Changes in IL-6 in blood
Time frame: Baseline, fasting day 10, food reintroduction day 3
Changes in IL-8 in blood
Time frame: Baseline, fasting day 10, food reintroduction day 3
Changes in IL-17 in blood
Time frame: Baseline, fasting day 10, food reintroduction day 3
Changes in IL-10 in gingival crevicular fluid
Time frame: Baseline, fasting day 10, food reintroduction day 3
Changes in G-CSF in gingival crevicular fluid
Time frame: Baseline, fasting day 10, food reintroduction day 3
Changes in IFN-γ in gingival crevicular fluid
Time frame: Baseline, fasting day 10, food reintroduction day 3
Changes in TNF-α in gingival crevicular fluid
Time frame: Baseline, fasting day 10, food reintroduction day 3
Changes in IL-1β in gingival crevicular fluid
Time frame: Baseline, fasting day 10, food reintroduction day 3
Changes in IL-6 in gingival crevicular fluid
Time frame: Baseline, fasting day 10, food reintroduction day 3
Changes in IL-8 in gingival crevicular fluid
Time frame: Baseline, fasting day 10, food reintroduction day 3
Changes in IL-17 in gingival crevicular fluid
Time frame: Baseline, fasting day 10, food reintroduction day 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Françoise Wilhelmi de Toledo, MD principal investigator
Buchinger Wilhelmi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Long-term fasting in people with Healthy and Periodontitis, run by Buchinger Wilhelmi Development & Holding GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in halitosis (time frame: daily from baseline to the 3rd day of food reintroduction). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2023.