Application of a Fasting-mimicking Diet in Obese Patients With Periodontitis Stage III-IV

NCT07549633 | Not Yet Recruiting

• 1 other identifier: Akdeniz-U
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate whether a fasting-mimicking diet (FMD) can improve the systemic and periodontal response to non-surgical periodontal treatment in obese adults with severe periodontitis. Periodontitis is a serious inflammatory disease that damages the tissues supporting the teeth and may also contribute to inflammation elsewhere in the body. Obesity is also associated with increased systemic inflammation, which may worsen periodontal disease and affect treatment outcomes. In this pilot randomized cross-over clinical trial, eligible participants will receive full-mouth non-surgical periodontal therapy and will be assigned either to an FMD group or to a control group continuing their usual diet. The FMD will be administered in three 5-day cycles around the periodontal treatment period. After a wash-out period, the groups will switch interventions. The study will assess whether FMD can reduce systemic inflammation, measured primarily by serum C-reactive protein (CRP), and improve periodontal healing after treatment. Additional outcomes include clinical periodontal measurements, inflammatory markers in gingival crevicular fluid, and changes in oral and gut microbiota. Findings from this study will help determine the feasibility of this dietary approach and provide preliminary data for a larger clinical trial.

Conditions

Periodontitis (Stage 3); Periodontitis Stage IV

Keywords

non surgical treatment; periodontitis; fasting mimicking diet; systemic response

Outcome Measures

Primary Outcomes (1)

• Serum CRP values

  CRP level will be evaluated biochemically

  at 90- and 360 days post-treatment

Secondary Outcomes (5)

• Serum CRP values

  baseline, 1 day post-treatment, 7 days post-treatment, 45 days post-treatment, 180 days post-treatment, 225 days post-treatment, 270 days post-treatment

• Analysis of inflammatory cytokines in GCF

  baseline, 1 day post-treatment, 7 days post-treatment, 45 days post-treatment, 180 days post-treatment, 225 days post-treatment, 270 days post-treatment

• Analysis of sub-gingival plaque samples

  baseline, 90 days post-treatment, 180 days post-treatment and 360 days post-treatment

• Patients reported quality of life measurements

  baseline, 90 days post-treatment, 180 days post-treatment and 360 days post-treatment

• Analysis of stool samples

  Baseline and at 90 days post-treatment, 180 days post-treatment and 360 days post-treatment

Study Arms (2)

Fasting mimicking diet group

EXPERIMENTAL

Participants will receive standard non-surgical periodontal therapy and three 5-day cycles of a fasting-mimicking diet administered around the treatment period.

Dietary Supplement: Fast mimicking diet group

Normal diet group

ACTIVE COMPARATOR

Participants will receive standard non-surgical periodontal therapy and will continue their usual diet during the study period.

Procedure: Normal diet group

Interventions

Fast mimicking diet group DIETARY_SUPPLEMENT

Participants assigned to this intervention will undergo standard non-surgical periodontal therapy and will receive a fasting-mimicking diet (FMD) in three 5-day cycles administered around the treatment period. The FMD is a plant-based, calorie-restricted dietary program composed of foods generally recognized as safe, including vegetable-based soups, energy bars, energy drinks, cracker snacks, olives, herbal teas, and supplements. The regimen provides approximately 1,100 kcal on day 1 and approximately 750 kcal per day on days 2 to 5.

Fasting mimicking diet group

Normal diet group PROCEDURE

Participants assigned to this intervention will undergo standard non-surgical periodontal therapy and will continue their usual diet without receiving the fasting-mimicking diet during the assigned study phase.

Normal diet group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• year-old patients,
• Severe Periodontitis (Stages III-IV),
• Systemically healthy,
• Overweight (body mass index - BMI \> 30 kg/m2),
• Absence of hopeless teeth, acute dental conditions, endo-perio lesions and necrotising periodontal diseases,
• Minimum of 20 teeth present.

You may not qualify if:

• Current smokers,
• Pregnant women,
• Patients drinking more than 20 units of alcohol weekly,
• Taking medications including systemic anti-inflammatory medication within 3 months of the study,
• Periodontal treatment and/or systemic antibiotics intake within preceding 3 months
• Denture wearer/presence of dental implants,
• Significant food allergies and/or special dietary requirements which would make the subject unable to consume the food provided.

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Akdeniz University Faculty of Dentistry

Antalya, 07070, Turkey (Türkiye)

Location

Related Publications (1)

• Mainas G, Ozgu I, Sari A, Vinciguerra M, Ide M, Ayakta BB, Ustun K, Nibali L. The application of a fasting-mimicking diet in periodontitis. A feasibility study. J Dent. 2025 May;156:105644. doi: 10.1016/j.jdent.2025.105644. Epub 2025 Feb 19.

  PMID: 39983975 RESULT

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Luigi Nibali, Prof. Dr.

  King's College London, Guy's Hospital

  STUDY DIRECTOR

• Kemal Üstün, Prof. Dr.

  Akdeniz University

  PRINCIPAL INVESTIGATOR

• Mükerrem Hatipoğlu, Prof. Dr.

  Akdeniz University

  PRINCIPAL INVESTIGATOR

• Giuseppe Mainas, Dr.

  King's College London, Guy's Hospital

  STUDY DIRECTOR

Central Study Contacts

İpek Özgü

CONTACT

+90 545 525 83 08; ipekozgu7@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the dietary intervention, participants and treating clinicians cannot be blinded. However, clinical outcome assessors and the statistician will remain blinded to treatment allocation until completion of the analysis.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: April 24, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)