Food Biodiversity and Human Health

Periodontal Diseases Clinical Trial

— BIOQUALIM  

Official title:

BIOQUALIM: From Cultivated Biodiversity to Prevention in Human Health

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06315088
• Other study ID #: 69HCL24_0144
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2024
• Est. completion date: March 1, 2025

Study information

• Verified date: March 2024
• Source: Hospices Civils de Lyon
• Contact: Denis Bourgeois
• Phone: 04 27 85 40 00
• Email: denis.bourgeois[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: March 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Oral Microbiota
• Periodontal Diseases

Intervention

Other:
• Einkorn Diet
Analysis of the oral microbiota before (T0) and after (T2) introduction of einkorn into the diet by interdental sampling, on 4 sites, pooled then analyzed by bacterial PCR.
• Intermediate oral microbiota
Comparison of the number of total bacteria and pathogens of the interdental microbiota before (T0) and in interim analysis (T1) for evaluation of the minimum period of effectiveness, by interdental sampling, on 4 sites, pooled then analyzed by bacterial PCR.
• Periodontal health status
Analysis of the periodontal and oral clinical parameters (plaque index, gingival index, interdental inflammation, pocket depth and loss of clinical attachment, salivary pH) before (T0) and after (T2) introduction of einkorn into the diet, by sampling and periodontal analysis of all of the participants' teeth
• General health status
Analysis of general health indicators (body mass index, measurement of abdominal circumference, blood pressure, MOS SF-36 quality of life questionnaire and eating habits) before (T0) and after (T2) introduction of einkorn in the diet

Locations

Country	Name	City	State
France	Maison des professionnels	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total periodontal bacteria count	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.	Baseline (T0), 3 months after baseline (T2)
Secondary	Intermediate periodontal bacteria count	Comparison of the number of total bacteria and pathogens of the interdental microbiota before (T0) and in interim analysis (T1) for evaluation of the minimum period of effectiveness, by interdental sampling, on 4 sites, pooled then analyzed by bacterial PCR.	Baseline (T0), 1 month later (T1)
Secondary	Periodontal health analysis:plaque index	Comparison of periodontal and oral clinical parameters (plaque index) before (T0), intermediate (T1) and after (T2) introduction of einkorn into the diet, by sampling and periodontal analysis of all of the participants' teeth	Baseline (T0), 1 month later (T1), 3 months after baseline (T2)
Secondary	Periodontal health analysis: gingival index	Comparison of periodontal and oral clinical parameters (gingival index) before (T0), intermediate (T1) and after (T2) introduction of einkorn into the diet, by sampling and periodontal analysis of all of the participants' teeth	Baseline (T0), 1 month later (T1), 3 months after baseline (T2)
Secondary	Periodontal health analysis : pocket depth and loss of clinical attachment	Comparison of periodontal and oral clinical parameters (pocket depth and loss of clinical attachment) before (T0), intermediate (T1) and after (T2) introduction of einkorn into the diet, by sampling and periodontal analysis of all of the participants' teeth	Baseline (T0), 1 month later (T1), 3 months after baseline (T2)
Secondary	Periodontal health analysis : interdental inflammation	Comparison of periodontal and oral clinical parameters (interdental inflammation) before (T0), intermediate (T1) and after (T2) introduction of einkorn into the diet, by sampling and periodontal analysis of all of the participants' teeth	Baseline (T0), 1 month later (T1), 3 months after baseline (T2)
Secondary	Periodontal health analysis : salivary pH	Comparison of periodontal and oral clinical parameters (salivary pH) before (T0), intermediate (T1) and after (T2) introduction of einkorn into the diet, by sampling and periodontal analysis of all of the participants' teeth	Baseline (T0), 1 month later (T1), 3 months after baseline (T2)
Secondary	General health analysis : body mass index	Comparison of general health indicators (body mass index) before (T0), intermediate (T1) and after (T2) introduction of einkorn in the diet, by a consultation and a general medical examination	Baseline (T0), 1 month later (T1), 3 months after baseline (T2)
Secondary	General health analysis : measurement of abdominal circumference	Comparison of general health indicators (measurement of abdominal circumference) before (T0), intermediate (T1) and after (T2) introduction of einkorn in the diet, by a consultation and a general medical examination	Baseline (T0), 1 month later (T1), 3 months after baseline (T2)
Secondary	General health analysis : blood pressure	Comparison of general health indicators (blood pressure) before (T0), intermediate (T1) and after (T2) introduction of einkorn in the diet, by a consultation and a general medical examination	Baseline (T0), 1 month later (T1), 3 months after baseline (T2)
Secondary	General health analysis : MOS SF-36 quality of life questionnaire	Comparison of general health indicators (MOS SF-36 quality of life questionnaire) before (T0), intermediate (T1) and after (T2) introduction of einkorn in the diet, by a consultation and a general medical examination	Baseline (T0), 1 month later (T1), 3 months after baseline (T2)
Secondary	General health analysis : eating habits	Comparison of general health indicators (eating habits) before (T0), intermediate (T1) and after (T2) introduction of einkorn in the diet, by a consultation and a general medical examination	Baseline (T0), 1 month later (T1), 3 months after baseline (T2)