Trials / Completed
CompletedNCT05449249
Oral and Gut Microbiota Changes During Long-term Fasting in Humans
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- Buchinger Wilhelmi Development & Holding GmbH · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Long-term fasting | The participants will undergo a fasting program that includes the daily intake of 250 kcal under medical supervision. |
Timeline
- Start date
- 2022-09-01
- Primary completion
- 2022-10-08
- Completion
- 2023-01-06
- First posted
- 2022-07-08
- Last updated
- 2023-01-13
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT05449249. Inclusion in this directory is not an endorsement.