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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group | Experimental | Participants will consume a 250cl bottle of soluble fibre-enriched kombucha mid-morning or mid-afternoon, avoiding consumption after eating. The drink will be included in a healthy eating plan. They will be advised to continue their usual physical activity during the 6 weeks of the study. |
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| Control Group | Placebo Comparator | Participants will consume one 250cl bottle of a similar unfermented and unfortified beverage mid-morning or mid-afternoon, avoiding consumption after eating. The beverage will be included in a healthy eating plan. Participants will be advised to continue their usual physical activity for the 6 weeks of the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kombucha tea | Dietary Supplement | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Relative abundance of the gut microbial species | Analyze the variations in the relative abundance of the microbial species present, including taxonomic identification, diversity analysis, and phylogenetic composition. | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imdea Food | Madrid | Madrid | 28049 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40689297 | Derived | Arce-Lopez B, Bazan GX, Molina S, Crespo MC, Garcia-Beccaria M, Cruz-Gil S, Fernandez-Diaz CM, Ramirez de Molina A, Ramos-Ruiz R, Espinosa-Salinas MI. Effect of fiber-modified kombucha tea on gut microbiota in healthy population: A randomized controlled trial (RCT). Curr Res Food Sci. 2025 Jun 26;11:101130. doi: 10.1016/j.crfs.2025.101130. eCollection 2025. |
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| ID | Term |
|---|---|
| D000068858 | Kombucha Tea |
| ID | Term |
|---|---|
| D013662 | Tea |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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Prospective, parallel, randomized 6-week nutritional intervention study.
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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.
|
| D000088082 |
| Fermented Beverages |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D000074421 | Fermented Foods |
| D019602 | Food and Beverages |