NCT06626997

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: IMDEA Food · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Kombucha 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).

Timeline

• Start date: 2024-01-22
• Primary completion: 2024-03-14
• Completion: 2024-06-28
• First posted: 2024-10-04
• Last updated: 2025-05-09

Locations

1 site across 1 country: Spain