RecruitingNot Applicable

Kombucha in Overweight and Obese: Live Vs. Pasteurized Effects on Microbiota, Metabolism, and Liver Function

Portugal33 participantsStarted 2024-10-11

Plain-language summary

Kombucha, a fermented beverage made from Camellia sinensis tea (black, oolong, or green) with sugar and a symbiotic culture of bacteria and yeast (SCOBY), has gained global attention for its potential health benefits. Factors like the type and amount of sugar substrate, fermentation time, and temperature significantly influence its organic compounds, total phenolics, vitamin content, and alcohol levels. In a previous study, kombucha's impact on glucose tolerance, insulin sensitivity, body composition, and liver function was tested in male prediabetic mice with diet-induced obesity. Daily supplementation (200 µL per mouse) improved glucose tolerance after nine days (equivalent to one year in humans) and reduced liver steatosis, despite no changes in body composition. Although kombucha has been associated with antioxidant, antimicrobial, probiotic, antidiabetic, and anticancer activities, strong scientific evidence in humans remains limited. Further clinical studies are needed to substantiate kombucha's health benefits in humans.

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. Subjects with sensitivity to kombucha;
. Consumption of kombucha, kefir, kimchi, cheese, raw vinegar, sauerkraut, kvass, and other fermented products during the study and in the 3 weeks before the study.
. Use of antibiotics in the 6 months prior to the start of the study;
. Use of pro/prebiotics or fibers as dietary supplements or any food/molecule that modifies intestinal transit time 6 weeks before recruitment; use of laxatives 6 weeks before recruitment;
. Specific dietary regimen (e.g., vegan); specific dietary treatment (e.g., high protein);
. Excessive consumption of substances and alcohol; smokers;
. Diagnosis of gastrointestinal disorders, hormonal or thyroid diseases, autoimmune diseases, and/or chronic use of corticosteroids; psychiatric disease; Type 1 or 2 diabetes;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Gut microbiota composition and diversity (fecal samples)

Timeframe: 4 weeks

Change in fasting glucose levels

Timeframe: 4 weeks

Change in fasting insulin levels

Timeframe: 4 weeks

Changes in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) values

Timeframe: 4 weeks

Changes in Lipid profile

Timeframe: 4 weeks

Trial details

NCT IDNCT06759324

SponsorAssociação Centro de Apoio Tecnológico Agro Alimentar

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-02-28

Contact for this trial

Inês Brandão, PhD

+351926777221 inesbrandao@cataa.pt

View on ClinicalTrials.gov More Obesity and Overweight trials

Plain-language summary

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. Subjects with sensitivity to kombucha;
. Consumption of kombucha, kefir, kimchi, cheese, raw vinegar, sauerkraut, kvass, and other fermented products during the study and in the 3 weeks before the study.
. Use of antibiotics in the 6 months prior to the start of the study;
. Use of pro/prebiotics or fibers as dietary supplements or any food/molecule that modifies intestinal transit time 6 weeks before recruitment; use of laxatives 6 weeks before recruitment;
. Specific dietary regimen (e.g., vegan); specific dietary treatment (e.g., high protein);
. Excessive consumption of substances and alcohol; smokers;
. Diagnosis of gastrointestinal disorders, hormonal or thyroid diseases, autoimmune diseases, and/or chronic use of corticosteroids; psychiatric disease; Type 1 or 2 diabetes;

What they're measuring

Change in Gut microbiota composition and diversity (fecal samples)

Timeframe: 4 weeks

Change in fasting glucose levels

Timeframe: 4 weeks

Change in fasting insulin levels

Timeframe: 4 weeks

Changes in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) values

Timeframe: 4 weeks

Changes in Lipid profile

Timeframe: 4 weeks