Oral MicrobiotaBIOQUALIMNCT06315088
Food Biodiversity and Human Health
A study testing Einkorn Diet, Intermediate oral microbiota and Periodontal health status in people with Oral Microbiota and Periodontal Diseases, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Oral Microbiota, Periodontal Diseases
- What is being tested?
- Einkorn Diet, Intermediate oral microbiota and Periodontal health status
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteFrance
- Study dates
- 13 Feb 2025to 27 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: BIOQUALIM: From Cultivated Biodiversity to Prevention in Human Health
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.
Read more
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
- Being tested
- Einkorn Diet, Intermediate oral microbiota, Periodontal health status, General health status
- Keywords
- biodiversity, diet, environmental and medical impact, oral health, oral microbiota, general health, quality of life
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Einkorn DietOther
Also called Total Oral microbiota
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 microbiotaOther
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 statusOther
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 statusOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Einkorn Diet; Other: Intermediate oral microbiota; Other: Periodontal health status; Other: General health status |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (T0), 3 months after baseline (T2)
Secondary outcomes (11)
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.
Measured: Baseline (T0), 1 month later (T1)
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
Measured: Baseline (T0), 1 month later (T1), 3 months after baseline (T2)
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
Measured: Baseline (T0), 1 month later (T1), 3 months after baseline (T2)
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
Measured: Baseline (T0), 1 month later (T1), 3 months after baseline (T2)
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
Measured: Baseline (T0), 1 month later (T1), 3 months after baseline (T2)
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
Measured: Baseline (T0), 1 month later (T1), 3 months after baseline (T2)
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
Measured: Baseline (T0), 1 month later (T1), 3 months after baseline (T2)
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
Measured: Baseline (T0), 1 month later (T1), 3 months after baseline (T2)
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
Measured: Baseline (T0), 1 month later (T1), 3 months after baseline (T2)
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
Measured: Baseline (T0), 1 month later (T1), 3 months after baseline (T2)
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
Measured: Baseline (T0), 1 month later (T1), 3 months after baseline (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start13 Feb 2025
- Primary completion24 Feb 2025
- Study completion27 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral MicrobiotaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06315088
- Sponsor's protocol ID
- 69HCL24_0144
- Acronym
- BIOQUALIM
- Status last verified
- Feb 2026
- First submitted
- 1 Mar 2024
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39458490
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BIOQUALIM: From Cultivated Biodiversity to Prevention in Human Health
- ClinicalTrials.gov ID
- NCT06315088
- Acronym / sponsor ID
- BIOQUALIM / 69HCL24_0144
- Conditions
- Oral Microbiota, Periodontal Diseases
- Keywords
- biodiversity, diet, environmental and medical impact, oral health, oral microbiota, general health, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 13 Feb 2025 (actual)
- Primary completion
- 24 Feb 2025 (actual)
- Study completion
- 27 May 2025 (actual)
- First posted
- 18 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Einkorn Diet | Experimental | Other: Einkorn Diet, Other: Intermediate oral microbiota, Other: Periodontal health status, Other: General health statusHealthy 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). |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Einkorn DietAlso: Total Oral microbiotaAnalysis 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. | Other | Einkorn Diet |
| Intermediate oral microbiotaComparison 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. | Other | Einkorn Diet |
| Periodontal health statusAnalysis 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 | Other | Einkorn Diet |
| General health statusAnalysis 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 | Other | Einkorn Diet |
Primary outcome
Total periodontal bacteria count
Time frame: 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.
11 secondary outcomes
Intermediate periodontal bacteria count
Time frame: Baseline (T0), 1 month later (T1)
Periodontal health analysis:plaque index
Time frame: Baseline (T0), 1 month later (T1), 3 months after baseline (T2)
Periodontal health analysis: gingival index
Time frame: Baseline (T0), 1 month later (T1), 3 months after baseline (T2)
Periodontal health analysis : pocket depth and loss of clinical attachment
Time frame: Baseline (T0), 1 month later (T1), 3 months after baseline (T2)
Periodontal health analysis : interdental inflammation
Time frame: Baseline (T0), 1 month later (T1), 3 months after baseline (T2)
Periodontal health analysis : salivary pH
Time frame: Baseline (T0), 1 month later (T1), 3 months after baseline (T2)
General health analysis : body mass index
Time frame: Baseline (T0), 1 month later (T1), 3 months after baseline (T2)
General health analysis : measurement of abdominal circumference
Time frame: Baseline (T0), 1 month later (T1), 3 months after baseline (T2)
General health analysis : blood pressure
Time frame: Baseline (T0), 1 month later (T1), 3 months after baseline (T2)
General health analysis : MOS SF-36 quality of life questionnaire
Time frame: Baseline (T0), 1 month later (T1), 3 months after baseline (T2)
General health analysis : eating habits
Time frame: Baseline (T0), 1 month later (T1), 3 months after baseline (T2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Results publication: PubMed 39458490Murat-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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Einkorn Diet, Intermediate oral microbiota and Periodontal health status in people with Oral Microbiota and Periodontal Diseases, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total periodontal bacteria count (time frame: Baseline (T0), 3 months after baseline (T2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06315088, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026; AzTrials last refreshed its copy on 7 Nov 2026.