Effect of a Symbiotic Drink on the Microbiota

NCT06626997 | Completed

• 1 other identifier: IMD: PI-060
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Kombucha; Microbiota

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Dietary Supplement: Kombucha tea

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.

Dietary Supplement: Kombucha tea

Interventions

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).

Control Group; Study Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• IMDEA Food: lead

Study Sites (1)

Imdea Food

Madrid, Madrid, 28049, Spain

Location

Related Publications (1)

• 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.

  PMID: 40689297 DERIVED

MeSH Terms

Interventions

Kombucha Tea

Intervention Hierarchy (Ancestors)

Tea; Plant Preparations; Biological Products; Complex Mixtures; Fermented Beverages; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Fermented Foods; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective, parallel, randomized 6-week nutritional intervention study.

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: October 4, 2024
• Study Start: January 22, 2024
• Primary Completion: March 14, 2024
• Study Completion: June 28, 2024
• Last Updated: May 9, 2025

Record last verified: 2025-05

Locations

ES (1)