Effects of kombucha on overweight and obese individuals
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]
This study is testing whether drinking live or pasteurized kombucha can help people who are overweight or mildly obese improve their health over four weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 33 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Associação Centro de Apoio Tecnológico Agro Alimentar Academic / other |
| Locations | 2 sites (Castelo Branco, Castelo Branco District and 1 other locations) |
| Trial ID | NCT06759324 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of kombucha, a fermented beverage, on individuals with overweight and class 1 obesity. Participants aged 18 to 60 will be randomly assigned to receive either live kombucha, pasteurized kombucha, or sparkling water for four weeks. The study aims to assess metabolic parameters such as glucose and insulin levels, lipid profiles, gut microbiota composition, and liver function. By comparing the effects of live versus pasteurized kombucha, the research seeks to understand the potential health benefits of this beverage.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 18 to 60 with a Body Mass Index (BMI) between 25 kg/m² and 34.9 kg/m².
Not a fit: Patients with sensitivities to kombucha or those who have consumed fermented products recently may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into how kombucha consumption may improve metabolic health and liver function in overweight and obese individuals.
How similar studies have performed: While previous studies have shown promising results with kombucha in animal models, strong scientific evidence in humans remains limited, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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. Exclusion Criteria: Volunteers will be excluded from the study if they present one or more of the following conditions: 1. Subjects with sensitivity to kombucha; 2. 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. 3. Use of antibiotics in the 6 months prior to the start of the study; 4. 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; 5. Specific dietary regimen (e.g., vegan); specific dietary treatment (e.g., high protein); 6. Excessive consumption of substances and alcohol; smokers; 7. Diagnosis of gastrointestinal disorders, hormonal or thyroid diseases, autoimmune diseases, and/or chronic use of corticosteroids; psychiatric disease; Type 1 or 2 diabetes; 8. Use of proton pump inhibitors; antidiabetic drugs or insulin and statins; 9. Subjects with insulin sensitivity; 10. Pregnant or lactating women; 11. Subjects with tooth sensitivity 12. Participation in another clinical trial in the last 3 months.
Where this trial is running
Castelo Branco, Castelo Branco District and 1 other locations
- Centro de Apoio Tecnológico Agro Alimentar (CATAA) — Castelo Branco, Castelo Branco District, Portugal (Recruiting)
- Centro de Apoio Tecnológico Agro Alimentar (CATAA) (facilities temporarily provided by the Affidea clinical analysis center) — Covilha, Portugal (Recruiting)
Study contacts
- Principal investigator: Brandão, PhD — Cataa
- Study coordinator: Inês Brandão, PhD
- Email: inesbrandao@cataa.pt
- Phone: +351926777221
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.