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Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
ID06759324

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

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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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