Evaluation of the Effect of Kefir Consumption

NCT07522372 | Active Not Recruiting

• 2 other identifiers: 2023-A02587-3824.00472.000223
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Well-being; Emotion

Keywords

Biomarkers; Related; Probiotic; Kefir

Outcome Measures

Primary Outcomes (1)

• Evaluate the effects of fruit kefir

  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.

  3 years

Secondary Outcomes (6)

• 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

Study Arms (3)

BRAS-C

Consumption of a control beverage, non-fermented carbonated drink

Other: Consumption of a control beverage, non-fermented carbonated drink

BRAS-F

Consumption of fruit kefir

Other: Consumption of fruit kefir

BRAS-P

Consumption of micro-filtered fruit kefir

Other: Consumption of micro-filtered fruit kefir

Interventions

Consumption of a control beverage, non-fermented carbonated drink OTHER

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.

BRAS-C

Consumption of micro-filtered fruit kefir OTHER

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.

BRAS-P

Consumption of fruit kefir OTHER

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.

BRAS-F

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A total of 66 subjects will be recruited on a voluntary basis : * 22 subjects who will consume a control beverage, non-fermented carbonated drink (BRAS-C) * 22 subjects who will consume fruit kefir (BRAS-F) * 22 subjects who will consume micro-filtered fruit kefir (BRAS-P). The distribution of subjects into the 3 BRAS will be carried out by a controlled randomized method.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sys2Diag: lead
• Centre National de la Recherche Scientifique, France: collaborator

Study Sites (1)

SYS2DIAG - UMR9005 CNRS/ALCEN, Montpellier, 34184

Montpellier, France

Location

Related Publications (5)

• Renaud Debailly, Christophe Lavelle et Émilien Schultz, " Conserver un aliment vivant ", Techniques & Culture, 69 | 2018, URL : http://journals.openedition.org/tc/8971

  RESULT

• Laureys D,De Vuyst L

  RESULT

• Molina L,Santos Schneider F,Kahli M,Ouedraogo A,Alali M,Almosnino A,Baptiste J,Boulestreau J,Davy M,Houot-Cernettig J,Mountou T,Quenot M,Simphor E,Petit V,Molina F

  RESULT

• Pendon MD, Bengoa AA, Iraporda C, Medrano M, Garrote GL, Abraham AG. Water kefir: Factors affecting grain growth and health-promoting properties of the fermented beverage. J Appl Microbiol. 2022 Jul;133(1):162-180. doi: 10.1111/jam.15385. Epub 2021 Dec 20.

  PMID: 34822204 RESULT

• Lopitz-Otsoa F, Rementeria A, Elguezabal N, Garaizar J. Kefir: a symbiotic yeasts-bacteria community with alleged healthy capabilities. Rev Iberoam Micol. 2006 Jun;23(2):67-74. doi: 10.1016/s1130-1406(06)70016-x.

  PMID: 16854180 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Saliva and urine

Study Officials

• Laurence MOLINA, PhD

  Sys2Diag

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project Manager

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 13, 2026
• Study Start: June 4, 2024
• Primary Completion: June 11, 2025
• Study Completion (Estimated): June 11, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

FR (1)