protocolSection identificationModule nctId: NCT06315088, orgStudyIdInfo id: 69HCL24_0144, briefTitle: Food Biodiversity and Human Health, acronym: BIOQUALIM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-10-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-03-01, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Hospices Civils de Lyon, class: OTHER, descriptionModule briefSummary: In Western countries, one of the major nutritional challenges requires reducing the proportion of animal proteins and increasing the proportion of vegetable proteins in the daily plate. Added to this nutritional challenge is an environmental challenge, with plant proteins being much less expensive to produce. However, plant proteins are mainly provided by cereals and legumes, a large diversity of which is necessary to cover the recommended daily intake of amino acids. However, given the collapse of cultivated biodiversity (loss of 75% in 100 years, FAO), the diversity of the supply is very reduced.Furthermore, for several years, public health studies have indicated a chronic deficit in micronutrients (minerals/trace elements, vitamins, antioxidants) as well as fiber in the diet of the French population. This comes in particular from the impoverishment of the nutritional quality of the fruits/vegetables/cereals/legumes consumed. In general, diet plays a major role in the primary prevention of chronic diseases (cardiovascular, diabetes, cancer) including periodontal disease. Thus, a diet low in sugars, saturated fats and rich in fiber would reduce the appearance of periodontal disease by strengthening salivary capacity. However, certain pathogenic periodontal bacteria (such as Porphyromonas gingivalis) can migrate (blood, digestive or respiratory routes) to reach other organs and represent a risk factor for other chronic diseases. Thus, the prevention of periodontal diseases through diet control would also contribute to the prevention of other chronic diseases.The benefit of plant-based diets to reduce the risk of cancer is now established. In addition, certain cereals such as spelled have superior nutritional qualities to common wheat, notably their protein content and they also contain higher quantities of certain bioactive compounds with anti-cancer properties (such as phytosterols).Furthermore, the potential impact of the oral microbiota on chronic diseases is now being studied: in healthy adults, a dysbiotic periodontal microbiota may be likely to lead to systemic para-inflammation. It has also been shown that a dietary change (Mediterranean diet) could lead to a reduction in pathogenic bacteria in the oral microbiota (including P. gingivalis). However, the link between the introduction of cereals into the diet and the evolution of cancer risk factor bacteria in the oral microbiota has never been demonstrated.This pilot clinical study plans to focus on the oral microbiota, with the aim of objectivizing a possible link between a modification of the diet by the introduction of cereals (einkorn type) and the evolution of certain bacteria of this microbiota., notably P. gingivalis (but also T. forsythia, S. anginosus, A. actinomycetemcomitans, T. denticola and F. nucleatum), considered as cancer risk factors and thus observe an improvement in health status oral and general., conditionsModule conditions: Oral Microbiota, conditions: Periodontal Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Einkorn Diet, interventions name: Intermediate oral microbiota, interventions name: Periodontal health status, interventions name: General health status, outcomesModule primaryOutcomes measure: Total periodontal bacteria count, secondaryOutcomes measure: Intermediate periodontal bacteria count, secondaryOutcomes measure: Periodontal health analysis:plaque index, secondaryOutcomes measure: Periodontal health analysis: gingival index, secondaryOutcomes measure: Periodontal health analysis : pocket depth and loss of clinical attachment, secondaryOutcomes measure: Periodontal health analysis : interdental inflammation, secondaryOutcomes measure: Periodontal health analysis : salivary pH, secondaryOutcomes measure: General health analysis : body mass index, secondaryOutcomes measure: General health analysis : measurement of abdominal circumference, secondaryOutcomes measure: General health analysis : blood pressure, secondaryOutcomes measure: General health analysis : MOS SF-36 quality of life questionnaire, secondaryOutcomes measure: General health analysis : eating habits, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Maison des professionnels, city: Lyon, zip: 69000, country: France, contacts name: Bourgeois Denis, MD,PhD, role: CONTACT, phone: 04 27 85 40 00, email: denis.bourgeois@chu-lyon.fr, geoPoint lat: 45.74848, lon: 4.84669, hasResults: False