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]

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other, Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• Individuals with a Body Mass Index (BMI) between 25 kg/m² and 34.9 kg/m², of both biological sexes, aged between 18 and 60 years, available to comply with the study protocol (described in this document) and sign informed consent.

Locations
Other Locations
Portugal
Centro de Apoio Tecnológico Agro Alimentar (CATAA)
RECRUITING
Castelo Branco
Centro de Apoio Tecnológico Agro Alimentar (CATAA) (facilities temporarily provided by the Affidea clinical analysis center)
RECRUITING
Covilha
Contact Information
Primary
Inês Brandão, PhD
inesbrandao@cataa.pt
+351926777221
Backup
Filomena Pereira, Nutritionist
filomenapereira@cataa.pt
Time Frame
Start Date: 2024-10-11
Estimated Completion Date: 2025-02-28
Participants
Target number of participants: 33
Treatments
Experimental: Intervention: Kombucha (live drink)
The first arm receives a daily amount of 33 cl of kombucha (live drink) for 4 weeks (dietary supplement).
Experimental: Intervention: Pasteurized kombucha
The second arm receives a daily amount of 33 cl of kombucha (pasteurized drink) for 4 weeks (dietary supplement).
Active_comparator: Sparkling water
The third arm receives 33 cl of sparkling water for 4 weeks (control).
Sponsors
Leads: Associação Centro de Apoio Tecnológico Agro Alimentar

This content was sourced from clinicaltrials.gov