Effect of a Symbiotic Drink on the Microbiota (KOMFIBRA)

IMDEA Food

Status: Completed

Conditions: Healthy Volunteers

Treatments: Dietary Supplement: Kombucha tea

Study type: Interventional

Funder types: Other

Identifiers

NCT06626997

IMD: PI-060

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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 exclusion criteria that the principal investigator of the study considers relevant.
• Non-Caucasian ethnicity

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Study Group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Kombucha tea

Control Group

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Kombucha tea