Fasting-mimicking Diet and Periodontitis (FMD)

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

Interventions

PROCEDURE

Fasting-mimicking diet + non-surgical periodontal therapy

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.

Sponsors & Collaborators

• Universidad Complutense de Madrid

  collaborator OTHER

• University of Santiago de Compostela

  collaborator OTHER

• Universidad de Granada

  collaborator OTHER

• Universidad de Murcia

  collaborator OTHER

• King's College London

  collaborator OTHER

• Universitat Internacional de Catalunya

  lead OTHER

Principal Investigators

• Luigi Nibali, DDS, PhD · King's College London

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-12-04

Primary Completion

2024-04-26

Completion

2024-11-30

Countries

• Spain

Study Locations