Effect of a Symbiotic Drink on the Microbiota

NCT ID: NCT06626997

Last Updated: 2025-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-22
• Study Completion Date: 2024-06-28

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Study Group

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.

Group Type: EXPERIMENTAL

Kombucha tea

Intervention Type: 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).

Control Group

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.

Group Type: PLACEBO_COMPARATOR

Kombucha tea

Intervention Type: 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).

Interventions

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).

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.
• Non-Caucasian ethnicity

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

IMDEA Food

OTHER

Sponsor Role: lead

Responsible Party

María Isabel Espinosa

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Imdea Food

Madrid, Madrid, Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 40689297 (View on PubMed)

Other Identifiers

IMD: PI-060

Identifier Type: -

Identifier Source: org_study_id