RecruitingNot ApplicableNCT06759324

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

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]


Sponsor

Associação Centro de Apoio Tecnológico Agro Alimentar

Enrollment

33 participants

Start Date

Oct 11, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Control (sparkling water), Live kombucha (non filtered/ non pasteurized), and others for people with obesity and overweight. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTLive 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_SUPPLEMENTPasteurized kombucha (non filtered)

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

OTHERControl (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

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NCT06759324


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