Actively Recruiting
Randomized Controlled Pilot Study of Live Versus Pasteurized Kombucha in Overweight and Class 1 Obesity Assessing Gut Microbiota, Metabolism, and Liver Function FUSILLI Project - H2020
Led by Associação Centro de Apoio Tecnológico Agro Alimentar · Updated on 2025-01-06
33
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are exploring the effects of kombucha, a fermented tea beverage, on individuals who are overweight or have class 1 obesity. This study aims to understand how kombucha, including its live microbiota, influences metabolic factors like glucose, insulin, and lipid levels, as well as gut microbiota diversity and liver function. The trial is a randomized controlled pilot study assessing these impacts through clinical and biological measures. Participants are randomly assigned to one of three groups one group drinks 33 cl of live kombucha daily, another drinks 33 cl of pasteurized kombucha daily, and a third group drinks 33 cl of sparkling water as a control. Each intervention lasts for 4 weeks, and the study includes dietary supplementation with the assigned beverage. The trial involves a triple-blind design to reduce bias. During the study, participants undergo assessments of their gut microbiota through fecal samples, fasting glucose and insulin levels, insulin resistance, lipid profiles, liver enzymes, and biomarkers of oxidative stress and inflammation. Questionnaires about gastrointestinal symptoms and stool consistency are also completed. The trial aims to measure changes over the 4-week period to evaluate kombuchas potential effects on metabolism, microbiota, and liver health.
CONDITIONS
Brief Title
Kombucha in Overweight and Obese: Live Vs. Pasteurized Effects on Microbiota, Metabolism, and Liver Function
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals aged 18 to 60 years
- Body Mass Index (BMI) between 25 and 34.9 kg/m²
- Both biological sexes
- Available to comply with the study protocol and sign informed consent
You will not qualify if you...
- Sensitivity to kombucha
- Consumption of kombucha, kefir, kimchi, cheese, raw vinegar, sauerkraut, kvass, or other fermented products during the study or in the 3 weeks before
- Use of antibiotics in the 6 months before the study
- Use of pro/prebiotics, fibers as supplements, or laxatives 6 weeks before recruitment
- Specific dietary regimen or treatment (e.g., vegan, high protein)
- Excessive alcohol use or smoking
- Diagnosis of gastrointestinal, hormonal, thyroid, autoimmune, psychiatric diseases, or chronic corticosteroid use
- Type 1 or 2 diabetes
- Use of proton pump inhibitors, antidiabetic drugs, insulin, or statins
- Insulin sensitivity
- Pregnant or lactating women
- Tooth sensitivity
- Participation in another clinical trial in the last 3 months
Research Team
I
Inês Brandão, PhD
F
Filomena Pereira, Nutritionist
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