Fasting-mimicking Diet and Periodontitis (FMD)

NCT06074861 | Completed

• 1 other identifier: PER-ECL-2022-02
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 5

Brief Summary

Periodontitis (gum disease) leads to the formation of gum pockets. Its treatment involves deep cleaning of the teeth, to remove soft and hard tooth deposits under the gum line. Although in the long term this leads to improvement of the gum conditions and reduced inflammation, in the hours and days post-treatment, inflammation may increase, sometimes also associated with a high temperature. A method to reduce this response has not been found yet. The goal of this multi-centre randomized controlled trial is to to test if a diet which acts to mimic periodic fasting can influence responses in the mouth and throughout the body after treatment of gum disease in patients with advanced gum disease but general health conditions. Five Spanish centres (Universidad Complutense de Madrid, Universidad Internacional de Catalunya, Universidad de Murcia, Universidad de Santiago de Compostela, Universidad de Granada) will perform the clinical part of the study, whereas the King's College of London (Guy's Hospital) will provide the analyses and processing of the data. Researchers will include 28 patients in total. The main question it aims to answer is: \- Is a mimic periodic fasting (together with the classical gum treatment) effective at reducing the local and systemic inflammation provoked by the gum disease (and by the same treatment) in the short- and medium term? Although all participants will receive the necessary gum treatment (deep cleaning), researchers will randomly assign them to one of two groups. The test group will follow three cycles (the same day of the treatment, and 45- and 85 days after treatment) of 5 days each of a fasting-mimicking diet (FMD). The FMD program is a plant-based diet program designed to attain fasting-like effects while providing both macro- and micronutrients to minimize the burden of fasting and adverse effects. The FMD consists of 100% ingredients that are generally regarded as safe (GRAS) and comprises proprietary vegetable-based soups, energy bars, energy drinks, cracker snacks, olives, herbal teas, and supplements. All items to be consumed per day are individually boxed. In contrast, the control group will continue with their current diet. All patients will complete dietary diaries to estimate calorie intake during this time period. Researchers will collect blood, stool, plaque and gingival crevicular fluid samples from each patient at different time points. Besides, they will call the patients one or two times during each FMD cycle to check that everything is proceeding properly and to solve any problems or concerns they may have. In addition, a trained registered dietitian will be available during the whole study period in case participants need some support or have doubts and/or questions. If participants miss multiple visits (e.g. 2/3) will be considered as a drop-out and, if they develop a serious medical condition, they might be excluded from the study. However, independently from the participation into this study, each patient will have their gum disease regularly treated. People with periodontal disease usually have a bad dietary-habits. This investigation with its holistic approach might lead people to modify their unbalanced diet due to the possible related local and systemic benefits. In addition, cycles of 5 days might consistently raise the adherence and willingness to follow such a fasting regime.

Conditions

Periodontal Disease, AVDC Stage 3; Periodontal Disease, AVDC Stage 4; Periodontitis

Outcome Measures

Primary Outcomes (1)

• High-sensitivity C-reactive protein (hs-CRP) values in serum

  Blood samples will be taken. A multiple bead immunoassay technique (Luminex) will be used to detect the serum levels of CRP (as alternative ELISA technique may be used). CRP will be measured in milligrams of the protein per liter of plasma (mg/L).

  It will be measured at baseline and 90 days after treatment.

Secondary Outcomes (9)

• Hs-CRP values in serum

  It will be measured at baseline and 1-, 7-, 45- and 180 days after treatment

• Clinical attachment level (CAL)

  It will be measured at baseline (before treatment) and 90- and 180 days after treatment

• Probing pocket depth (PPD)

  It will be measured at baseline (before treatment) and 90- and 180 days after treatment

• Bleeding on probing (BOP)

  It will be measured at baseline (before treatment) and 90- and 180 days after treatment

• Plaque index (PI)

  It will be measured at baseline (before treatment) and 90- and 180 days after treatment

Study Arms (2)

Test group

ACTIVE COMPARATOR

Patients will receive the non-surgical periodontal therapy plus three cycles of fasting-mimicking diet.

Procedure: Fasting-mimicking diet + non-surgical periodontal therapy

Control group

NO INTERVENTION

Patients will receive the non-surgical periodontal therapy and will continue with their normal (and ad libitum) diet.

Interventions

Fasting-mimicking diet + non-surgical periodontal therapy PROCEDURE

Test group will receive a full-mouth non-surgical periodontal therapy (also named professional mechanical plaque removal-PMPR) and, in the same day (starting at morning), a fasting-mimicking diet (FMD) will be started (for a cycle of 5 days). Other two cycles of FMD will be followed at 45- and 85- days after treatment, respectively.

Test group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-70 years
• Periodontitis stages III-IV, generalized, grade C-B (according to the New World Workshop 2017)
• Minimum of 20 teeth present: to ensure there are sufficient teeth for study and that the same teeth can be examined in all participants.
• Systemically healthy participants (self-reported questionnaires will be used).
• Body mass index: 18.5-30 kg/m2 (normal weight to overweight, but not obese)
• Be willing and competent (verbally and cognitively) to give written informed consent and complete a medical history form
• Be willing and physically able to carry out all study procedures (e.g. multiple cycles of a 5-day dietary regimen and blood samples)
• Absence of hopeless teeth, acute dental conditions, teeth with endodontic-periodontal lesions and necrotising periodontal diseases

You may not qualify if:

• Less than 20 teeth present
• Patients who received any periodontal treatment in the last 12 months
• Smoking (defined as self-reported use of any cigarettes or electronic cigarettes for at least 5 years): to avoid the potential confounding effect of smoking
• Mental illness, including severe depression, dementia. To ensure safety and compliance of the protocol
• Drug dependency
• Hormone replacement therapy (DHEA, estrogen, thyroid, testosterone).
• Severe hypertension (systolic BP \> 200 mm Hg and/or diastolic BP \> 105 mm Hg)
• Underweight (BMI \< 18.5 kg/m2)
• Currently taking part in other clinical trials: to prevent either from interfering with the results of the other
• Pregnant or breastfeeding women: to prevent hormonal changes from influencing the amount of inflammation
• Taking medications including systemic anti-inflammatory medication within 3 months of the study (NSAIDs, no more than once per week and not in the week before sample collection, is permitted)
• Systemic antibiotic intake within 3 months: to prevent their microbiome-modulating effects from impacting the inflammatory status.
• Current orthodontic treatment: interferes with plaque control measures.
• Alcoholism (alcohol intake greater than two drinks per day for women and three drinks per day for men)
• Denture wearer/presence of dental implants: They may have an effect on periodontal parameters of neighbouring teeth

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead
• Universidad Complutense de Madrid: collaborator
• University of Santiago de Compostela: collaborator
• Universidad de Granada: collaborator
• Universidad de Murcia: collaborator
• King's College London: collaborator

Study Sites (5)

Universitat Internacional de Catalunya

Sant Cugat del Vallès, Barcelona, Spain

Location

Universidad de Granada

Granada, Spain

Location

Universidad Complutense de Madrid

Madrid, Spain

Location

Universidad de Murcia

Murcia, Spain

Location

Universida de Santiago de Compostela

Santiago de Compostela, Spain

Location

Related Publications (5)

• Wei M, Brandhorst S, Shelehchi M, Mirzaei H, Cheng CW, Budniak J, Groshen S, Mack WJ, Guen E, Di Biase S, Cohen P, Morgan TE, Dorff T, Hong K, Michalsen A, Laviano A, Longo VD. Fasting-mimicking diet and markers/risk factors for aging, diabetes, cancer, and cardiovascular disease. Sci Transl Med. 2017 Feb 15;9(377):eaai8700. doi: 10.1126/scitranslmed.aai8700.

  PMID: 28202779 BACKGROUND

• Longo VD, Di Tano M, Mattson MP, Guidi N. Intermittent and periodic fasting, longevity and disease. Nat Aging. 2021 Jan;1(1):47-59. doi: 10.1038/s43587-020-00013-3. Epub 2021 Jan 14.

  PMID: 35310455 BACKGROUND

• Graziani F, Cei S, Tonetti M, Paolantonio M, Serio R, Sammartino G, Gabriele M, D'Aiuto F. Systemic inflammation following non-surgical and surgical periodontal therapy. J Clin Periodontol. 2010 Sep;37(9):848-54. doi: 10.1111/j.1600-051X.2010.01585.x. Epub 2010 Jun 4.

  PMID: 20546085 BACKGROUND

• Machado V, Botelho J, Escalda C, Hussain SB, Luthra S, Mascarenhas P, Orlandi M, Mendes JJ, D'Aiuto F. Serum C-Reactive Protein and Periodontitis: A Systematic Review and Meta-Analysis. Front Immunol. 2021 Jul 28;12:706432. doi: 10.3389/fimmu.2021.706432. eCollection 2021.

  PMID: 34394107 BACKGROUND

• Mainas G, Santamaria P, Ide M, Longo V, Vinciguerra M, Nart J, Nibali L. Could dietary restrictions affect periodontal disease? A systematic review. Clin Oral Investig. 2023 Aug;27(8):4107-4116. doi: 10.1007/s00784-023-05052-9. Epub 2023 May 18.

  PMID: 37199773 BACKGROUND

MeSH Terms

Conditions

Periodontal Diseases; Periodontitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Luigi Nibali, DDS, PhD

  King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: There will be a Test group and a Control group

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: October 10, 2023
• Study Start: December 4, 2023
• Primary Completion: April 26, 2024
• Study Completion: November 30, 2024
• Last Updated: October 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (5)