Effect of a Symbiotic Drink on the Microbiota (NCT06626997) | Clinical Trial Compass
CompletedNot Applicable
Effect of a Symbiotic Drink on the Microbiota
Spain60 participantsStarted 2024-01-22
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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