NCT06759324Recruiting
Kombucha in Overweight and Obese: Live Vs. Pasteurized Effects on Microbiota, Metabolism, and Liver Function
Randomized Controlled Pilot Clinical Study Including Kombucha in the Diet of Individuals with Overweight and Class 1 Obesity: Comparative Assessment Between Live and Pasteurized Kombucha and Its Effects on Gut Microbiota, Metabolic Parameters, and Liver Function [FUSILLI Project -H2020]
Source: ClinicalTrials.gov · Last updated 6 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 33 (estimated)
- First submitted
- 9 Dec 2024
- Start date
- 11 Oct 2024
- Primary completion date
- 28 Feb 2025
- Lead sponsor
- Associação Centro de Apoio Tecnológico Agro Alimentar
- Diseases
- Obesity
- NCT number
- NCT06759324
What you commit to
- Study type: Interventional
- Planned participants: 33
- From 11 Oct 2024 to the primary completion date, 28 Feb 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
- Use of proton pump inhibitors; antidiabetic drugs or insulin and statins;
Other illness
- Volunteers will be excluded from the study if they present one or more of the following conditions:
- Diagnosis of gastrointestinal disorders, hormonal or thyroid diseases, autoimmune diseases, and/or chronic use of corticosteroids; psychiatric disease; Type 1 or 2 diabetes;
Other
- Subjects with sensitivity to kombucha;
- Specific dietary regimen (e.g., vegan); specific dietary treatment (e.g., high protein);
- Excessive consumption of substances and alcohol; smokers;
- Subjects with insulin sensitivity;
- Pregnant or lactating women;
- Subjects with tooth sensitivity
- Participation in another clinical trial in the last 3 months.
Who the study is looking for
- Individuals with a Body Mass Index (BMI) between 25 kg/m² and 34.9 kg/m², of both biological sexes, aged between 18 and 60 years, available to comply with the study protocol (described in this document) and sign informed consent.
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centro de Apoio Tecnológico Agro Alimentar (CATAA) Coordinator of this site? Confirm its status | Castelo Branco | Portugal | Recruiting |
| Centro de Apoio Tecnológico Agro Alimentar (CATAA) (facilities temporarily provided by the Affidea clinical analysis center) Coordinator of this site? Confirm its status | Covilha | Portugal | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.