Actively Recruiting

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

Study of Live vs. Pasteurized Kombucha Effects on Gut Health, Metabolism, and Liver Function in Overweight and Class 1 Obesity

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

Researchers are investigating the effects of kombucha, a fermented tea beverage, on individuals who are overweight or have class 1 obesity. The study focuses on how kombucha impacts gut microbiota composition, metabolic parameters such as glucose and insulin levels, lipid profiles, and liver function. Previous animal studies suggested potential benefits, but this clinical study aims to provide stronger evidence in humans through a randomized controlled pilot trial. Participants will be randomly assigned to one of three groups: one group will consume 33 cl of live (non-pasteurized, non-filtered) kombucha daily, another will consume 33 cl of pasteurized kombucha daily, and the control group will receive 33 cl of sparkling water daily. Each intervention lasts for 4 weeks (28 days), allowing comparison between the effects of live versus pasteurized kombucha and the control on health markers. During the 4-week study, participants will provide fecal samples to analyze gut microbiota changes and undergo measurements of fasting glucose, insulin levels, insulin resistance (HOMA-IR), and lipid profiles. The study will monitor these outcomes to evaluate the metabolic and microbiome effects of kombucha consumption. Participants must comply with the study protocol and attend scheduled assessments throughout the study period.

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

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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

F

Filomena Pereira, Nutritionist

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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Published Research Related To This Trial