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RECRUITING
NCT06759324
NA

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

Sponsor: Associação Centro de Apoio Tecnológico Agro Alimentar

View on ClinicalTrials.gov

Summary

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.

Official title: 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]

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

33

Start Date

2024-10-11

Completion Date

2025-02-28

Last Updated

2025-01-06

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Live kombucha (non filtered/ non pasteurized)

Participants receive a daily amount of 33 cl of live kombucha (non-pasteurized/ non-filtered) for 4 weeks (28 days).

DIETARY_SUPPLEMENT

Pasteurized kombucha (non filtered)

Participants receive a daily amount of 33 cl of kombucha (pasteurized drink) for 4 weeks (28 days).

OTHER

Control (sparkling water)

Participants receive a daily amount of 33 cl of sparkling water for 4 weeks.

Locations (2)

Centro de Apoio Tecnológico Agro Alimentar (CATAA)

Castelo Branco, Castelo Branco District, Portugal

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

Covilha, Portugal