Application of a Fasting-mimicking Diet in Obese Patients With Periodontitis Stage III-IV
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorAkdeniz University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
18-70-year-old patients,
Severe Periodontitis (Stages III-IV),
Systemically healthy,
Overweight (body mass index - BMI > 30 kg/m2),
Disqualifiers
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,
Trial design
Design model
Crossover
Treatments tested in this trial
Fast mimicking diet group
Dietary supplementParticipants 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.
Normal diet group
Procedure/SurgeryParticipants 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Fasting mimicking diet groupExperimental treatment 1 intervention
Group B: Normal diet groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Serum CRP values
CRP level will be evaluated biochemically
Time frame
at 90- and 360 days post-treatmentSecondary outcomes
1
Serum CRP values
Time frame
baseline, 1 day post-treatment, 7 days post-treatment, 45 days post-treatment, 180 days post-treatment, 225 days post-treatment, 270 days post-treatment2
Analysis of inflammatory cytokines in GCF
Time frame
baseline, 1 day post-treatment, 7 days post-treatment, 45 days post-treatment, 180 days post-treatment, 225 days post-treatment, 270 days post-treatment3
Analysis of sub-gingival plaque samples
Relative abundance of selected periodontal pathogens in sub-gingival plaque samples
Time frame
baseline, 90 days post-treatment, 180 days post-treatment and 360 days post-treatment4
Patients reported quality of life measurements
Patients' outcomes will be assessed by Oral Health Impact Profile-14 (OHIP-14) questionnaire which is used to evaluate the impact oral health (including functional limitations, pain, physiological discomfort, physical disability, social disability, sense of taste, diet unsatisfactory and handicap) on person's life. The Oral Health Impact Profile-14 (OHIP-14) was designed to assess patients' perception of the impact of oral disorders on their quality of life (QoL).
Time frame
baseline, 90 days post-treatment, 180 days post-treatment and 360 days post-treatmentSponsors and contacts
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Source ClinicalTrials.gov
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