Emotion, Well-being
Conditions
Keywords
Biomarkers, Related, Probiotic, Kefir
Brief summary
Many societies traditionally use fermentation as a means of producing beverages, whose microbial transformation is spontaneously triggered or facilitated by the addition of a catalyst (yeasts, bacteria). Kefir is a traditional beverage belonging to the latter category. It is a probiotic that is supposed to modify the intestinal microbiota and the metabolites produced. Links between kefir and metabolic syndromes (insulin resistance, etc.) have also been described in animal models. Very few clinical studies have evaluated the effects of kefir in humans. A 'positive feeling' has also been described by people who consume kefir. Kefir could therefore have an effect on people's well-being.
Detailed description
Many societies traditionally use fermentation as a means of producing beverages, whose microbial transformation is spontaneously triggered or facilitated by the addition of a catalyst (yeasts, bacteria). Kefir is a traditional beverage belonging to the latter category. This beverage is obtained by inoculating sugared water, supplemented with fresh and dried fruits, with translucent grains composed of symbiotic microorganism communities (mainly lactic acid bacteria and yeasts). Kefir conveys an image of a 'healthy' beverage, naturally sparkling and non-alcoholic (alcohol content \<1%), rich in probiotics), which undoubtedly explains the enthusiasm it generates among consumers. The traditional nature of kefir lies in the use of fresh kefir grains as the sole ferment, passed down from producer to producer over generations. Kefir is a probiotic that is supposed to modify the intestinal microbiota and the metabolites produced. Recent studies have described positive health effects of kefir. These effects could be exerted by a combination of live microorganisms contained in the fermented beverage, as well as by the bioactive components released in foods as by-products of the fermentation process. Links between kefir and metabolic syndromes (insulin resistance, etc.) have also been described in animal models. Very few clinical studies have evaluated the effects of kefir in humans. Branched-chain amino acids (BCAAs) are provided by the diet and are essential to the human body. They are also markers of insulin resistance. Measuring metabolites such as BCAAs in biofluids would verify if kefir has an effect on food degradation and thus on the intake of essential amino acids. This information is important both to better understand the mechanism of action of kefir and its effects on the production of metabolites such as BCAAs.
Interventions
OTHERConsumption of a control beverage, non-fermented carbonated drink
Consumption of a control beverage, non-fermented carbonated drink and measurement of the concentrations of metabolites such as BCAAs (valine, leucine, and isoleucine) in the biofluids (urine and saliva) of subjects, before and after regular consumption of fruit kefir.
OTHERConsumption of fruit kefir
Consumption of fruit kefir and measurement of the concentrations of metabolites such as BCAAs (valine, leucine, and isoleucine) in the biofluids (urine and saliva) of subjects, before and after regular consumption of fruit kefir.
OTHERConsumption of micro-filtered fruit kefir
Consumption of micro-filtered fruit kefir and measurement of the concentrations of metabolites such as BCAAs (valine, leucine, and isoleucine) in the biofluids (urine and saliva) of subjects, before and after regular consumption of fruit kefir.
Sponsors
Sys2Diag
Centre National de la Recherche Scientifique, France
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
: * Subject aged between 18 and 65 years * Subject agreeing to follow the study procedures * Subject capable of understanding the purpose, nature, and methodology of the study * Subject having signed the informed consent * Subject who has never regularly consumed kefir and/or kombucha.
Exclusion criteria
: * Pregnant or breastfeeding woman * Subject not affiliated with a French Social Security scheme or not a beneficiary of such a scheme * Subject deprived of liberty, protected adults, vulnerable persons, or minors * Refusal to sign the consent to participate in the research * Subject who has already regularly consumed kefir and/or kombucha * Subject with confirmed diabetes Criteria for Discontinuation of Participation in the Research : * Withdrawal of consent to participate in the research * Investigator's decision * Occurrence of a non-inclusion criterion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the effects of fruit kefir | 3 years | Evaluate the effects of fruit kefir on the release of amino acids such as BCAAs and more generally of metabolites in human biofluids (urine and saliva). The measurement of the concentrations of metabolites such as BCAAs (valine, leucine, and isoleucine) carried out in the biofluids (urine and saliva) of subjects, before and after regular consumption of fruit kefir using IDIR enzymatic dosage kit for BCAAs in a urine sample (SkillCell, France) according to the supplier's instructions. The concentrations are expressed in µM. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the effects of kefir on the well-being of participants | 3 years | Evaluate the effects of kefir on the well-being of participants who regularly consume this beverage, by measuring molecular biomarkers linked to the emotions felt. The levels of four biomarkers of interest (cortisol, alpha-amylase, DHEA, and oxytocin) will be measured in the saliva of participating subjects using enzymatic dosage methods or ELISA-type methods carried out using commercial kits. Concentrations are expressed in pM for cortisol and oxytocin, in U/mL for alpha-amylase, and in nM for DHEA. |
| Compare the signatures of these molecular biomarkers in the saliva of subjects who consume different types of kefir preparations and subjects who consume a non-alcoholic carbonated placebo beverage | 3 years | The comparison of the signatures of the biomarkers (cortisol, DHEA, oxytocin abd lapha amylase) in the saliva of subjects who consume fruit kefir, micro-filtered fruit kefir, or a non-alcoholic carbonated control beverage. Saliva samples are collected before and after consuming kefir. The baseline concentrations of biomarkers observed prior to kefir consumption revealed relatively high inter-individual variability. To account for the above and differing units of measurement, biomarker values are expressed as ratios following kefir consumption relative to the baseline value (prior to kefir consumption), thereby enabling comparisons on a consistent scale. Emotional assessments will be performed using a questionnaire. The variation profiles of the four biomarkers will be associated to emotional profiles induced by the drinks. |
| Compare the rate of BCAAs in the urine and saliva | 3 years | Compare the rate of BCAAs in the urine and saliva of subjects who consume different types of kefir preparations and subjects who consume a non-alcoholic carbonated placebo beverage. |
| Establish a correlation between the rate of BCAAs and the molecular signature established | 3 years | Establish a correlation between the rate of BCAAs and the molecular signature established from the dosage of biological biomarkers linked to emotions. |
| Establish a correlation between the metabolic changes measured with the rate of BCAAs | 3 years | Establish a correlation between the metabolic changes measured with the rate of BCAAs and the evaluation of the feelings of consumers according to other criteria such as questionnaires (self-assessment) for example. |
| Establish a correlation between the molecular signature established from the dosage | 3 years | Establish a correlation between the molecular signature established from the dosage of biological biomarkers of emotions and the evaluation of the well-being of consumers according to other criteria such as questionnaires (self-assessment) for example. |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORLaurence MOLINA, PhD
Sys2Diag
Outcome results
None listed