Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
NCT06759324

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

Led by Associação Centro de Apoio Tecnológico Agro Alimentar · Updated on 2025-01-06

33

Participants Needed

2

Research Sites

20 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official 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 between 18 and 60 years
  • Body Mass Index (BMI) between 25 kg/m² and 34.9 kg/m²
  • Both biological sexes eligible
  • Willingness to comply with the study protocol and sign informed consent
Not Eligible

You will not qualify if you...

  • Sensitivity to kombucha
  • Consumption of kombucha or other fermented products within 3 weeks before or during the study
  • Antibiotic use within 6 months before the study
  • Use of probiotics, prebiotics, fibers, or laxatives within 6 weeks before recruitment
  • Following specific dietary regimens or treatments (e.g., vegan, high protein)
  • Excessive alcohol consumption or smoking
  • Diagnosis of gastrointestinal, hormonal, thyroid, autoimmune, psychiatric diseases, or diabetes types 1 or 2
  • Use of proton pump inhibitors, antidiabetic drugs, insulin, or statins
  • Presence of insulin sensitivity
  • Pregnant or lactating women
  • Tooth sensitivity
  • Participation in another clinical trial within the last 3 months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Centro de Apoio Tecnológico Agro Alimentar (CATAA)

Castelo Branco, Castelo Branco District, Portugal, 6000-459

Actively Recruiting

2

Centro de Apoio Tecnológico Agro Alimentar (CATAA) (facilities temporarily provided by the Affidea clinical analysis center)

Covilha, Portugal, 6200-077

Actively Recruiting

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Research Team

I

Inês Brandão, PhD

CONTACT

F

Filomena Pereira, Nutritionist

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

3

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