FMD
The Effect of a Fast-mimicking Diet on Periodontal Clinical and Systemic Response to Non-surgical Treatment of Stage III-IV Periodontitis: a Multi-centre Randomised Controlled Trial With Internal Pilot
Sponsor study identifier
interventional
28
1 country
5
Study Start
December 4, 2023
Actual (reported)Primary Completion
April 26, 2024
Actual (reported)Study Completion
November 30, 2024
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 30, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 27, 2023
Actual (reported)October 10, 2023
Actual (reported)December 4, 2023
Actual (reported)April 26, 2024
Actual (reported)November 30, 2024
Actual (reported)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.
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
Patients will receive the non-surgical periodontal therapy plus three cycles of fasting-mimicking diet.
Patients will receive the non-surgical periodontal therapy and will continue with their normal (and ad libitum) diet.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Universitat Internacional de Catalunya
Sant Cugat del Vallès, Barcelona, Spain
Universidad de Granada
Granada, Spain
Universidad Complutense de Madrid
Madrid, Spain
Universidad de Murcia
Murcia, Spain
Universida de Santiago de Compostela
Santiago de Compostela, Spain
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.
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.
Luigi Nibali, DDS, PhD
King's College London
28 participants (actual enrollment reported by the registry).
First Submitted
September 27, 2023
First Posted
October 10, 2023
Study Start
December 4, 2023
Actual (reported)Contact the study team to confirm eligibility.
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.
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.
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.
Primary Completion
April 26, 2024
Actual (reported)Study Completion
November 30, 2024
Actual (reported)Last Updated
October 6, 2025
Record last verified: 2025-09
IPD will be not shared. Data will be anonymized. In the future publication data of each patient will be pooled with the ones of the other patients according to the statistics method that will be followed.
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Source: ClinicalTrials.gov.
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