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

NCT07549633 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-04-24

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Fast mimicking diet group

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.

PROCEDURE

Normal diet group

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.

Sponsors & Collaborators

  • Akdeniz University

    lead OTHER

Principal Investigators

  • Luigi Nibali, Prof. Dr. · King's College London, Guy's Hospital

  • Kemal Üstün, Prof. Dr. · Akdeniz University

  • Mükerrem Hatipoğlu, Prof. Dr. · Akdeniz University

  • Giuseppe Mainas, Dr. · King's College London, Guy's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2027-01-01
Completion
2027-12-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07549633 on ClinicalTrials.gov