Food Biodiversity and Human Health

NCT ID: NCT06315088

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-13
• Study Completion Date: 2025-05-27

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.

Conditions

Oral Microbiota; Periodontal Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Einkorn Diet

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).

Group Type: EXPERIMENTAL

Einkorn Diet

Intervention Type: OTHER

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

Intervention Type: OTHER

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

Intervention Type: OTHER

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

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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

Intervention Type: OTHER

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

Intervention Type: OTHER

Other Intervention Names

Total Oral microbiota

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Maison des professionnels

Lyon, , France

Countries

France

Other Identifiers

69HCL24_0144

Identifier Type: -

Identifier Source: org_study_id