Clinical trial NCT06315088: Food Biodiversity and Human Health
Official title: BIOQUALIM: from Cultivated Biodiversity to Prevention in Human Health
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Oral Microbiota
Periodontal Diseases
Keywords: biodiversity
diet
environmental and medical impact
oral health
oral microbiota
general health
quality of life
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2024-03-18
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Person between 20 and 60 years old
* Person with an omnivorous diet
* Person who has given free, informed, express written consent
* Person affiliated to a French social security system
* Person with a body mass greater than 18 kg/m²
* Person able to attend at least 1 culinary workshop

Exclusion Criteria:

* Person with a smoking addiction
* Person with a known food allergy/intolerance
* Person unable to consume dairy or solid products (e.g. chocolate milk pudding, chocolate jelly)
* Person participating in another study related to nutrition
* Patients at high risk of infective endocarditis
* Person with chronic pathologies
* Person having taken antibiotic treatment during the month preceding the start of the study
* Pregnant, parturient or breastfeeding woman
* Minors
* Persons deprived of liberty by a judicial or administrative decision
* People receiving psychiatric care
* Persons admitted to a health or social establishment for purposes other than research
* Adults subject to a legal protection measure (guardianship, curatorship)
* Persons not affiliated to a social security scheme or beneficiaries of a similar scheme
* Person with fewer than 20 natural teeth
* Person performing interdental hygiene and/or daily mouthwashes.
* Person wearing orthodontic appliance
* Person with periodontal disease (stage ≥ II periodontal lesions according to the Chicago 2017 classification (i.e. PD ≥ 4 mm, and/or CAL ≥ 4 mm) and/or generalized (\>30% of sites )), active caries or during dental care

Primary outcomes:
measure: Total periodontal bacteria count
timeFrame: Baseline (T0), 3 months after baseline (T2)
Secondary outcomes:
measure: Intermediate periodontal bacteria count
timeFrame: Baseline (T0), 1 month later (T1)
measure: Periodontal health analysis:plaque index
timeFrame: Baseline (T0), 1 month later (T1), 3 months after baseline (T2)
measure: Periodontal health analysis: gingival index
timeFrame: Baseline (T0), 1 month later (T1), 3 months after baseline (T2)
measure: Periodontal health analysis : pocket depth and loss of clinical attachment
timeFrame: Baseline (T0), 1 month later (T1), 3 months after baseline (T2)
measure: Periodontal health analysis : interdental inflammation
timeFrame: Baseline (T0), 1 month later (T1), 3 months after baseline (T2)
measure: Periodontal health analysis : salivary pH
timeFrame: Baseline (T0), 1 month later (T1), 3 months after baseline (T2)
measure: General health analysis : body mass index
timeFrame: Baseline (T0), 1 month later (T1), 3 months after baseline (T2)
measure: General health analysis : measurement of abdominal circumference
timeFrame: Baseline (T0), 1 month later (T1), 3 months after baseline (T2)
measure: General health analysis : blood pressure
timeFrame: Baseline (T0), 1 month later (T1), 3 months after baseline (T2)
measure: General health analysis : MOS SF-36 quality of life questionnaire
timeFrame: Baseline (T0), 1 month later (T1), 3 months after baseline (T2)
measure: General health analysis : eating habits
timeFrame: Baseline (T0), 1 month later (T1), 3 months after baseline (T2)
Other outcomes:
Locations:
city: Lyon
country: France
facility: Maison des professionnels
Study officials:
References: