Food Biodiversity and Human Health

NCT06315088 | Completed

• 1 other identifier: 69HCL24_0144
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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

Keywords

biodiversity; diet; environmental and medical impact; oral health; oral microbiota; general health; quality of life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• 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: gingival 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)

Study Arms (1)

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).

Other: Einkorn Diet; Other: Intermediate oral microbiota; Other: Periodontal health status; Other: General health status

Interventions

Einkorn Diet 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.

Also known as: Total Oral microbiota

Einkorn Diet

Intermediate oral microbiota 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.

Einkorn Diet

Periodontal health status 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

Einkorn Diet

General health status 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

Einkorn Diet

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Maison des professionnels

Lyon, 69000, France

Location

Related Publications (1)

• Murat-Ringot A, Lan R, Fraticelli L, Fayet Y, Bourgeois D, Nugem R, Piton M, Goetz E, Preau M, Dutertre F, Bernoud-Hubac N, Basbous L, Lastmann A, Charreyre MT, Carrouel F. An Innovative One Health Approach: BIOQUALIM, a Transdisciplinary Research Action Protocol-From Cultivated Biodiversity to Human Health Prevention. Nutrients. 2024 Oct 15;16(20):3495. doi: 10.3390/nu16203495.

  PMID: 39458490 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Periodontal Diseases

Interventions

Health Status

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 18, 2024
• Study Start: February 13, 2025
• Primary Completion: February 24, 2025
• Study Completion: May 27, 2025
• Last Updated: February 20, 2026

Record last verified: 2026-02

Locations

FR (1)