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临床试验/NCT06315088
NCT06315088已完成不适用

BIOQUALIM: From Cultivated Biodiversity to Prevention in Human Health

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2025年2月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
31
试验地点
1
主要终点
Total periodontal bacteria count

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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
  • •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

研究组 & 干预措施

Einkorn Diet

Experimental

Healthy adult volunteers (not suffering from chronic pathologies) and non-smokers, having an omnivorous diet, and agreeing to change their eating habits for 3 months (reducing meat consumption by half and replacing it with einkorn).

干预措施: Intermediate oral microbiota (Other)

Einkorn Diet

Experimental

Healthy adult volunteers (not suffering from chronic pathologies) and non-smokers, having an omnivorous diet, and agreeing to change their eating habits for 3 months (reducing meat consumption by half and replacing it with einkorn).

干预措施: Periodontal health status (Other)

Einkorn Diet

Experimental

Healthy adult volunteers (not suffering from chronic pathologies) and non-smokers, having an omnivorous diet, and agreeing to change their eating habits for 3 months (reducing meat consumption by half and replacing it with einkorn).

干预措施: Einkorn Diet (Other)

Einkorn Diet

Experimental

Healthy adult volunteers (not suffering from chronic pathologies) and non-smokers, having an omnivorous diet, and agreeing to change their eating habits for 3 months (reducing meat consumption by half and replacing it with einkorn).

干预措施: General health status (Other)

结局指标

主要结局

Total periodontal bacteria count

时间窗: Baseline (T0), 3 months after baseline (T2)

Comparison of the number of total bacteria and pathogens of the interdental microbiota before (T0) and after (T2) introduction of einkorn into the diet, by interdental sampling, on 4 sites, pooled then analyzed by bacterial PCR.

次要结局

  • Intermediate periodontal bacteria count(Baseline (T0), 1 month later (T1))
  • Periodontal health analysis:plaque index(Baseline (T0), 1 month later (T1), 3 months after baseline (T2))
  • Periodontal health analysis : pocket depth and loss of clinical attachment(Baseline (T0), 1 month later (T1), 3 months after baseline (T2))
  • Periodontal health analysis : interdental inflammation(Baseline (T0), 1 month later (T1), 3 months after baseline (T2))
  • Periodontal health analysis : salivary pH(Baseline (T0), 1 month later (T1), 3 months after baseline (T2))
  • General health analysis : MOS SF-36 quality of life questionnaire(Baseline (T0), 1 month later (T1), 3 months after baseline (T2))
  • Periodontal health analysis: gingival index(Baseline (T0), 1 month later (T1), 3 months after baseline (T2))
  • General health analysis : blood pressure(Baseline (T0), 1 month later (T1), 3 months after baseline (T2))
  • General health analysis : body mass index(Baseline (T0), 1 month later (T1), 3 months after baseline (T2))
  • General health analysis : measurement of abdominal circumference(Baseline (T0), 1 month later (T1), 3 months after baseline (T2))
  • General health analysis : eating habits(Baseline (T0), 1 month later (T1), 3 months after baseline (T2))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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