Effect of a Symbiotic Drink on the Microbiota

Nutritional Intervention Study to Evaluate the Effect of a Symbiotic Drink on the Microbiota and Different Nutritional Markers in Healthy Volunteers

This study is expected to involve 60 volunteers who will be recruited by IMDEA-Alimentación and randomly assigned between a study group (which will consume the fermented drink) and a control group, which will consume a drink with similar characteristics, but without the presence of bioactive components.

At the beginning of the trial, you will have an interview (screening visit) with a dietician-nutritionist who will explain the entire procedure to you and answer any questions you may have about it. If it is confirmed that you meet the criteria to participate in the study, after your assent and informed consent have been obtained, you will be able to do so. At the first visit, you will be assigned a code by a random method (computerized) and neither you nor the researcher will know whether you are receiving the enriched product or the traditional one that will be used as a control.

Inclusion Criteria:

• Men and women ≥ 18 years of age.
• Caucasian ethnicity
• Adequate level of culture and understanding of the clinical study.
• Agree to voluntarily participate in the study and give written informed consent.

Exclusion Criteria:

• Subjects with dementia, mental illness or decreased cognitive function that prevents the study from being carried out.
• Subjects with serious diseases (liver, kidney, immunosuppressed, etc.).
• BMI ≥ 30 kg/m2, pregnant or breastfeeding women.
• Presence of immunological pathologies, gallstones, gastric ulcer or coagulation problems.
• Presence of any other specific pathology that contraindicates the intake of dietary supplements, specifically inulin and probiotics (diverticulitis, etc.).
• Subjects who are undergoing antibiotic treatment or consuming probiotic supplements.
• Subjects who are undergoing pharmacological treatment for weight loss.
• Subjects who refuse to follow the guidelines for healthy eating or the consumption of the study drink in the indicated guidelines.
• Any other exclusion criteria that the principal investigator of the study considers relevant.
• Non-Caucasian ethnicity