Evaluation of the Effect of Kefir Consumption on Urinary and Salivary Levels of Metabolites Such as BCAAs and on Biomarkers of Well-being
Overview
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Sys2Diag
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- Evaluate the effects of fruit kefir
Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
BRAS-C
Consumption of a control beverage, non-fermented carbonated drink
Intervention: Consumption of a control beverage, non-fermented carbonated drink (Other)
BRAS-F
Consumption of fruit kefir
Intervention: Consumption of fruit kefir (Other)
BRAS-P
Consumption of micro-filtered fruit kefir
Intervention: Consumption of micro-filtered fruit kefir (Other)
Outcomes
Primary Outcomes
Evaluate the effects of fruit kefir
Time Frame: 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 Outcomes
- Evaluate the effects of kefir on the well-being of participants(3 years)
- 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)
- Compare the rate of BCAAs in the urine and saliva(3 years)
- Establish a correlation between the rate of BCAAs and the molecular signature established(3 years)
- Establish a correlation between the metabolic changes measured with the rate of BCAAs(3 years)
- Establish a correlation between the molecular signature established from the dosage(3 years)
Investigators
Laurence MOLINA
Project Manager
Sys2Diag