Healthy Volunteers
Conditions
Keywords
Kombucha, Microbiota
Brief 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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTKombucha tea
During Visit 1 (week 0), a fasting blood test must be performed at the IMDEA Alimentación facilities to obtain different markers: blood lipids, blood glucose, etc. Approximately 20 mL will be extracted (for comparison, keep in mind that a donation requires 450 mL). The blood sample will be extracted by qualified nursing staff from the UNILABS Laboratory. The blood tests based on the security and privacy requirements for handling samples will be carried out by the same laboratory. You will also be asked to provide the stool sample that you must have collected at home prior to attending that visit with the material provided at the screening visit (V0) and at the intermediate visit (V2).
Sponsors
IMDEA Food
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
The study will be masked by using identical packaging for both the study group and the control group (placebo), which participants will consume at home or at their mealtimes during the 6 weeks of the intervention. The researchers themselves will administer the product (with identical external appearance for both groups) individually to each participant.
Intervention model description
Prospective, parallel, randomized 6-week nutritional intervention study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relative abundance of the gut microbial species | 6 weeks | Analyze the variations in the relative abundance of the microbial species present, including taxonomic identification, diversity analysis, and phylogenetic composition. |
Countries
Spain
Outcome results
None listed