Oral and Gut Microbiota Changes During Long-term Fasting in Humans

NCT ID: NCT05449249

Last Updated: 2023-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2023-01-06

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.

Conditions

Healthy; Periodontitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Long-term fasting

Long-term fasting according to the Buchinger Wilhelmi fasting program.

Group Type: EXPERIMENTAL

Long-term fasting

Intervention Type: PROCEDURE

The participants will undergo a fasting program that includes the daily intake of 250 kcal under medical supervision.

Interventions

Long-term fasting

The participants will undergo a fasting program that includes the daily intake of 250 kcal under medical supervision.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Buchinger Wilhelmi Clinic

UNKNOWN

Sponsor Role: collaborator

University of Geneva, Switzerland

OTHER

Sponsor Role: collaborator

King's College London

OTHER

Sponsor Role: collaborator

ETH Zurich (Switzerland)

OTHER

Sponsor Role: collaborator

Buchinger Wilhelmi Development & Holding GmbH

OTHER

Sponsor Role: lead

Responsible Party

Françoise Wilhelmi de Toledo

Scientific Director; Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Françoise Wilhelmi de Toledo, MD

Role: PRINCIPAL_INVESTIGATOR

Buchinger Wilhelmi

Locations

Buchinger Wilhelmi clinic

Überlingen, , Germany

Countries

Germany

Other Identifiers

BuWi_OralFast_2022

Identifier Type: -

Identifier Source: org_study_id